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CompletedNCT02625974Updated Aug 19, 2024Results posted

A Study to Learn How Well Nifurtimox Works and How Safe it is in Children Aged 0 to 17 Years With Chagas' Disease, an Inflammatory, Infectious Disease Caused by the Parasite Trypanosoma Cruzi

A Phase 3 interventional study of Nifurtimox (Lampit, BAYA2502) and Placebo in Chagas Disease, sponsored by Bayer. Completed at 25 sites in 3 countries. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2024-08-19.

Sponsored by Bayer · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
330
Allocation
Randomized
Ages
Up to 17 Years
Sex
All
01

Study summary

Researchers are looking for a better way to treat children who have an infectious disease caused by the parasite Trypanosoma cruzi (Chagas' disease).

Chagas'disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas' disease is left untreated, it can later cause serious heart and digestive problems.

The study treatment nifurtimox has been used for more than 50 years to treat Chagas' disease. When used early after infection, it kills the parasite. In people who have long-term Chagas' disease, it's no longer possible to kill the parasite. However, nifurtimox may help slow the progression of the disease and its most serious complications.

Nifurtimox was developed for use in adults only, but has also been used in children (off-label) for over 40 years. Currently it is available for doctors to give to adults and to children. However, there are not enough data about nifurtimox in children.

The main purpose of this study is to learn how well nifurtimox works in children aged 8 months to less than 18 years with Chagas' disease. To answer this, the researchers will compare the amount of antibodies against the parasite Trypanosoma cruzi in the serum (fluid from blood without the clotting factors) between children treated with nifurtimox for 60 days with untreated children from the past (control group):

  • 12 months and
  • 4 years after the end of treatment. The data for the control group will come from 2 previous studies conducted in children.
02

Conditions studied

  • Chagas Disease

Browse trials for

03

In context

Chagas Disease

73 studies on the registry are indexed under Chagas Disease; 5 are open to participants now.

This study's enrollment of 330 is above the median of 87 across 49 interventional studies indexed under Chagas Disease.

Browse Chagas Disease studies →

Lead sponsor

Bayer is the lead sponsor of 1,674 studies on the registry; 51 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 132 (62%) have results posted.

Browse Bayer studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Part 1:

  • Male and female pediatric subjects aged 0 days to younger than 18 years
  • Chagas' disease diagnosed/ confirmed for a) Subjects \< 8 months of age at randomization must demonstrate direct observation of Trypanosoma cruzi by concentration test; b) Subjects ≥ 8 months to \< 18 years of age at randomization must demonstrate a positive conventional ELISA result for both recombinant ELISA and total purified antigen ELISA

Part 2:

  • Male and female subjects who were randomized and received at least one dose of their assigned 60- or 30-day regimen of nifurtimox treatment

Exclusion criteria

Exclusion Criteria:

Part 1:

  • Subjects aged 0 to 27 days who, at birth, were pre-term, weighed less than 2500 g, or had a maximum Apgar score \< 7 at 5 minutes
  • Known evidence of Chagas' disease-related cardiomyopathy/ Chagas' heart disease
  • Known evidence of Chagas' disease-related gastrointestinal dysfunction (e.g. megaoesophagus, megacolon, or both) or Chagas' digestive disease
  • Serious manifestations of acute Chagas' disease, including myocarditis, meningoencephalitis, or pneumonitis
  • Known evidence of Chagas' disease-related damage to the peripheral nervous system or peripheral neuropathy
  • psychiatric disorder (e.g. moderate to severe depression, severe anxiety, or psychosis) or epilepsy
  • Subjects with / warnings to nifurtimox administration, or with conditions that may increase the risk of the undesirable effects of nifurtimox
  • Subjects who have had previous treatment with trypanocidal agents or an accepted indication for antiparasitic therapy (e.g. reactivation of Chagas' infection due to by several diseases or treatment with )
  • Subjects living in housing conditions where there is no active or effective vector control to Trypanosoma cruzi reinfection as determined by Ministry of Health guidelines in each country

Part 2:

  • Subjects with acute or chronic health conditions or congenital disorders which, in the opinion of the investigator, would make them unsuitable for participation in the clinical study
  • Subjects living in housing conditions where there is no active or effective vector-control to Trypanosoma cruzi reinfection as determined by Ministry of Health guideline of the respective country
  • Subjects with clinical manifestations of Chagas' disease-related gastrointestinal dysfunction or serious manifestations of acute Chagas' disease
  • Immuno-compromised subjects (e.g. with or treated with immunosuppressive drugs)
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
330 participants (actual)

Study arms

  • Experimental
    Nifurtimox 60 days / Arm 1

    Nifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment)

    Drug: Nifurtimox (Lampit, BAYA2502)

  • Experimental
    Nifurtimox 30 days / Arm 2

    Nifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo)

    Drug: Nifurtimox (Lampit, BAYA2502) · Drug: Placebo

Interventions

  • DrugNifurtimox (Lampit, BAYA2502)

    For pediatric participants with body weight ≤ 40 kg: dosage 10 to 20 mg/kg/day in three divided doses. For pediatric participants with body weight \> 40 kg: 8 - 10 mg/kg/day in three divided doses. 60 days or 30 days of nifurtimox treatment

  • DrugPlacebo

    Matching placebo

06

What researchers measure

Primary outcomes

  1. Part 1 - Percentage of Sero-reduction or Sero-conversion (Cured Subjects)

    Cure is defined as sero-reduction (in subjects ≥8 months to \<18 years of age at randomization) or sero-conversion (in all subjects). Sero-reduction is defined as a ≥20% reduction in optical density \[OD\]) measured by two conventional ELISA serology tests and sero-conversion is defined as negative Immunoglobulin G (IgG) concentration measured by two conventional ELISA serology tests. Subjects who have missing conventional serology results at the 12 month time point were treated as failures (ie, no cure). For the primary objective in the study, superiority over placebo was confirmed if the lower limit of the 95% Confidence Interval (CI) for the nifurtimox (60-day regimen) cure rate is greater than 16%, the larger of the upper limits of the 95% CIs for historical placebo control.

    Time frame: At 12 months post-treatment

  2. Part 2 - Incidence Rate of Seronegative Conversion in Subjects Received at Least One Dose of the 60-day Nifurtimox Treatment Regimen.

    Seronegative conversion measured by two types of assay (recombinant ELISA and indirect hemagglutination assay \[IHA\]) in subjects who were randomized and received at least one dose of the 60-day nifurtimox treatment regimen compared to an external control group of historical placebo patients with Chagas' disease. Incidence rate is the number of new cases of seronegative conversion over the study period (i.e., 4 years after end of nifurtimox treatment) divided by the person-time at risk. It was modelled using a Poisson distribution with a 2-sided 95% exact CI. Number of participants with events were reported.

    Time frame: Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1

Secondary outcomes

  1. Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2

    Measured in sub-population.

    Time frame: At Visit 2 (Day 1): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours

  2. Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 3

    Measured in sub-population.

    Time frame: At Visit 3 (Day 7): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours

  3. Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 6

    The evaluation was based on clinical examinations. Measured in sub-population.

    Time frame: At Visit 6 (Day 30): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours

  4. Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 8

    Measured in sub-population.

    Time frame: At Visit 8 (Day 60): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours

  5. Part 2 - Incidence Rate of Seronegative Conversion in Subjects Who Received at Least One Dose of the 30-day Nifurtimox Treatment Regimen

    Seronegative conversion measured by two types of assay (recombinant ELISA and indirect hemagglutination assay \[IHA\]) in subjects who were randomized and received at least one dose of the 30-day nifurtimox treatment regimen. Incidence rate is the number of new cases of seronegative conversion over the study period (i.e., 4 years after end of nifurtimox treatment) divided by the person-time at risk. It was modelled using a Poisson distribution with a 2-sided 95% exact CI. Number of participants with events were reported.

    Time frame: Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1

  6. Part 2 - ECG Signs of Established Chagas-related Cardiomyopathy

    Summary of subjects by evidence of established Chagas-related cardiomyopathy as measured by electrocardiogram (ECG). Evidence of established Chagas-related cardiomyopathy: Total

    Time frame: Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1

  7. Part 2 - Serological Response of Established Chagas-related Cardiomyopathy

    Summary of subjects by evidence of established Chagas-related cardiomyopathy as measured by Serological response. Evidence of established Chagas-related cardiomyopathy: Total

    Time frame: Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1

  8. Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA

    Summary and change from baseline of optical density values measured by total purified antigen ELISA. Optical density is the measure of absorbance, and is defined as the ratio of the intensity of light falling upon a material and the intensity transmitted.

    Time frame: Baseline and Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1

  9. Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA

    Summary and change from baseline of optical density values measured by recombinant ELISA. Optical density is the measure of absorbance, and is defined as the ratio of the intensity of light falling upon a material and the intensity transmitted.

    Time frame: Baseline and Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1

  10. Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 1

    The evaluation was based on clinical examinations.

    Time frame: At Visit 1 (before treatment started)

  11. Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 3

    The evaluation was based on clinical examinations.

    Time frame: Up to 7 days (Visit 3)

  12. Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 6

    The evaluation was based on clinical examinations.

    Time frame: Up to 30 days (Visit 6)

  13. Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 8

    The evaluation was based on clinical examinations.

    Time frame: Up to 60 days (Visit 8; end of treatment)

  14. Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 9

    The evaluation was based on clinical examinations.

    Time frame: Up to 90 days (Visit 9 post-treatment)

  15. Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 10

    The evaluation was based on clinical examinations.

    Time frame: Up to 240 days (Visit 10 post-treatment)

  16. Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 11

    The evaluation was based on clinical examinations.

    Time frame: Up to 420 days (Visit 11 post-treatment)

  17. Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age)

    Time frame: Up to 90 days (Visit 9 post-treatment)

  18. Part 1 - Number of Subjects With a Positive Serological Response Using Non-conventional Enzyme-linked Immunosorbent Assay-F29 (ELISAF29) Test

    The non-conventional ELISA-F29 test is considered an early marker of treatment efficacy in chronic Chagas disease.

    Time frame: Up to 420 days (Visit 11 post-treatment)

  19. Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results

    The qPCR is molecular technique, considered a tool to diagnose acute and congenital Chagas disease, as well as a marker to measure treatment failure when demonstrating positive (detectable) results

    Time frame: Up to 420 days (Visit 11 post-treatment)

  20. Part 1 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

    TEAEs comprised events which first occurred or worsened at or after first application of study drug during the course of the study up to and including 7 days after last application of study drug

    Time frame: up to 7 days after last application of study drug

  21. Part 2 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

    TEAEs comprised events which first occurred or worsened at study start up to end of study in part 2. In Part 2, only AEs considered at least possibly related to nifurtimox (administered in part 1) and those caused by protocol-related procedures were reported.

    Time frame: Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1

  22. Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment

    The Number Analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. The number of subjects represents subjects with at least one high laboratory assessment after start of treatment who had a normal or lower than normal laboratory assessment at baseline.

    Time frame: Up to 420 days (Visit 11 post-treatment)

  23. Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment

    The number analyzed represents the number of subjects at baseline with a normal or higher than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. The number of subjects represents subjects with at least one low laboratory assessment after start of treatment who had a normal or higher than normal laboratory assessment at baseline.

    Time frame: Up to 420 days (Visit 11 post-treatment)

  24. Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment

    The number analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. Subjects with missing or high abnormal values at baseline are not included in the number analyzed. The number of subjects represents subjects with at least one high laboratory assessment after start of treatment who had a normal or lower than normal laboratory assessment at baseline.

    Time frame: Up to 420 days (Visit 11 post-treatment)

  25. Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment

    The number analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. Subjects with missing or low abnormal values at baseline are not included in the number analyzed. The number of subjects represents subjects with at least one low laboratory assessment after start of treatment who had a normal or higher than normal laboratory assessment at baseline.

    Time frame: Up to 420 days (Visit 11 post-treatment)

  26. Part 1 - Number of Subjects With Treatment-emergent High Coagulation Abnormalities by Treatment

    The Number Analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. The number of subjects represents subjects with at least one high laboratory assessment after start of treatment who had a normal or lower than normal laboratory assessment at baseline.

    Time frame: Up to 420 days (Visit 11 post-treatment)

  27. Part 1 - Number of Subjects With Treatment-emergent Low Coagulation Abnormalities by Treatment

    The number analyzed represents the number of subjects at baseline with a normal or higher than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. The number of subjects represents subjects with at least one low laboratory assessment after start of treatment who had a normal or higher than normal laboratory assessment at baseline.

    Time frame: Up to 420 days (Visit 11 post-treatment)

  28. Part 1 - Number of Subjects With Abnormal Urinalysis Findings Considered as Clinically Significant or Reported as Adverse Events (AEs)

    Urinalysis was performed and the following parameters evaluated: bilirubin, blood (red blood cells, white blood cells), chorionic gonadotropin β, glucose, ketones, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen.

    Time frame: Up to 420 days (Visit 11 post-treatment)

  29. Part 1 - Number of Subjects With Abnormal ECG Findings Considered as Clinically Significant by Investigators

    Clinical significance of abnormal ECG was based on the judgement of the investigator

    Time frame: Up to 420 days (Visit 11 post-treatment)

  30. Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline

    Systolic Blood Pressure

    Time frame: Baseline and up to 420 days (Visit 11 post-treatment)

  31. Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline

    Diastolic Blood Pressure

    Time frame: Baseline and up to 420 days (Visit 11 post-treatment)

  32. Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline

    Respiratory Rate

    Time frame: Baseline and up to 420 days (Visit 11 post-treatment)

  33. Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline

    Heart Rate

    Time frame: Baseline and up to 420 days (Visit 11 post-treatment)

  34. Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline

    Temperature

    Time frame: Baseline and up to 420 days (Visit 11 post-treatment)

Other outcomes

  1. Part 1: Number of Participants Cured With 60-day Regimen Compared With Historical Active Control (Benznidazole)

    This exploratory efficacy analysis evaluated the cure rate assessed as seroconversion of nifurtimox after 1-year post-treatment follow-up with that of published data for benznidazole (Sosa Estani et al. 1998 and de Andrade et al. 1996) at 4- and 3-year post-treatment follow-up, respectively, used as historical control.

    Time frame: Up to 420 days (Visit 11 post-treatment)

  2. Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit

    Using frequencies of matches and mismatches to assess agreement Reactive = Reac ELISA Detectable = Detec qPCR Non-reactive = Nonreac ELISA Non-detectable = Nondetec qPCR Non evaluable = Noneval qPCR qPCR Missing = Miss qPCR Missing conventional testing = Miss ELISA

    Time frame: Up to 420 days (Visit 11 post-treatment)

  3. Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit

    Using frequencies of matches and mismatches to assess agreement Reactive = Reac ELISA Reactive = Reac F29 Non-reactive = Nonreac ELISA Non-reactive = Nonreac F29

    Time frame: Up to 420 days (Visit 11 post-treatment)

  4. Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit

    Using frequencies of matches and mismatches to assess agreement Reactive = Reac ELISA Reactive = Reac F29 Non-reactive = Nonreac ELISA Non-reactive= Nonreac F29

    Time frame: Up to 420 days (Visit 11 post-treatment)

  5. Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results

    Sero-reduction is defined as a =\> 20% reduction in optical density \[OD\]) using two conventional ELISA serology tests in subjects =\> 8 months to \< 18 years of age at randomization; Others: reactive results that are not sero-reduction in subjects =\> 8 months to \< 18 years of age at randomization; or reactive results in subjects \< 8 months of age at randomization. Non-reactive ELISA = Nonreac ELISA Non-reactive IHA = Nonreac IHA Reactive IHA decrease = Reac IHA dec React IHA nochange = Reac IHA nochange Reactive ELISA: seroreduction = Reac ELISA reduc Reactive ELISA: others = Reac ELISA other

    Time frame: Up to 420 days (Visit 11 post-treatment)

  6. Part 1 - Relationship Between Conventional ELISA Results in Terms of Cure or No Cure and IHA Results in All Patients

    Cure is defined as sero-reduction (in subjects =\> 8 months to \< 18 years of age at randomization) or sero-conversion (in all subjects). Sero-reduction is defined as a =\> 20% reduction in optical density \[OD\]) measured by two conventional ELISA serology tests and sero-conversion is defined as negative Immunoglobulin G \[IgG\] concentration measured by two conventional ELISA serology tests. Cure = Cure Non reactive/reactive decreasing = Nonreac/reac dec Reactive non-decreasing = Reac nondec No cure = No Cure Missing IHA testing = IHA missing

    Time frame: Up to 420 days (Visit 11 post-treatment)

07

Results

Posted Oct 29, 2019
Limitations and caveats
Abnormal findings on neurological examination by physical examination after Screening will be documented as AEs.

Participant flow

Part 1 of the study was conducted from 27 JAN 2016 (First subject first visit) to 25 JUL 2018 (Last subject last visit) in Argentina, Bolivia and Colombia. Part 2 of the study was conducted from 26 SEP 2018 (First subject first visit) to 10 AUG 2021 (Last subject last visit) in Argentina, Bolivia and Colombia.

Part 1
Participant flow — Part 1
MilestoneNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Started219111
Received treatment219111
Completed210108
Not completed93
Withdrew: Lost to follow-up93
Part 2
Participant flow — Part 2
MilestoneNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Started19798
Completed19191
Not completed67
Withdrew: Lost to follow-up46
Withdrew: Other, including due to the covid-19 pandemic21

Outcome measures

PrimaryPart 1 - Percentage of Sero-reduction or Sero-conversion (Cured Subjects)

Cure is defined as sero-reduction (in subjects ≥8 months to \<18 years of age at randomization) or sero-conversion (in all subjects). Sero-reduction is defined as a ≥20% reduction in optical density \[OD\]) measured by two conventional ELISA serology tests and sero-conversion is defined as negative Immunoglobulin G (IgG) concentration measured by two conventional ELISA serology tests. Subjects who have missing conventional serology results at the 12 month time point were treated as failures (ie, no cure). For the primary objective in the study, superiority over placebo was confirmed if the lower limit of the 95% Confidence Interval (CI) for the nifurtimox (60-day regimen) cure rate is greater than 16%, the larger of the upper limits of the 95% CIs for historical placebo control.

Time frame:
At 12 months post-treatment
Reported as:
Number · Percentage of subjects
Part 1 - Percentage of Sero-reduction or Sero-conversion (Cured Subjects)
Percentage of subjectsNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Part 1 - Percentage of Sero-reduction or Sero-conversion (Cured Subjects)32.9 (26.4 to 39.3)18.9 (11.2 to 26.7)
Statistical analysis
  • Nifurtimox 60 Days / Arm 1 vs Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 · Difference in cure rate: 14 · 95% CI 3.7 to 24.2
PrimaryPart 2 - Incidence Rate of Seronegative Conversion in Subjects Received at Least One Dose of the 60-day Nifurtimox Treatment Regimen.

Seronegative conversion measured by two types of assay (recombinant ELISA and indirect hemagglutination assay \[IHA\]) in subjects who were randomized and received at least one dose of the 60-day nifurtimox treatment regimen compared to an external control group of historical placebo patients with Chagas' disease. Incidence rate is the number of new cases of seronegative conversion over the study period (i.e., 4 years after end of nifurtimox treatment) divided by the person-time at risk. It was modelled using a Poisson distribution with a 2-sided 95% exact CI. Number of participants with events were reported.

Time frame:
Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1
Reported as:
Number · Participants
Part 2 - Incidence Rate of Seronegative Conversion in Subjects Received at Least One Dose of the 60-day Nifurtimox Treatment Regimen.
ParticipantsNifurtimox 60 Days / Arm 1
Part 2 - Incidence Rate of Seronegative Conversion in Subjects Received at Least One Dose of the 60-day Nifurtimox Treatment Regimen.16
Statistical analysis
  • Nifurtimox 60 Days / Arm 1 · Risk ratio (rr): 2.12 · 95% CI 1.21 to 3.45Person-year = 754
SecondaryPart 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2

Measured in sub-population.

Time frame:
At Visit 2 (Day 1): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours
Reported as:
Median · ug/L
Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2
ug/LNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
PredoseNA (NA to 26.8)NA (NA to NA)
5 - 10 MIN POSTNA (NA to 154.8)21.1 (NA to 695.0)
10 - 120 MIN POST78.2 (5.8 to 847.5)49.0 (NA to 524.3)
2 - 4 HOURS POST215.4 (77.9 to 516.3)300.7 (106.9 to 533.5)
4 - 8 HOURS POST267.6 (40.2 to 508.1)289.6 (103.2 to 301.0)
SecondaryPart 1 - Nifurtimox Concentration Over Time in Plasma at Visit 3

Measured in sub-population.

Time frame:
At Visit 3 (Day 7): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours
Reported as:
Median · ug/L
Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 3
ug/LNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Predose47.7 (NA to 407.6)38.3 (NA to 472.3)
5 - 10 MIN POST82.6 (NA to 561.6)56.0 (NA to 442.8)
10 - 120 MIN POST250.6 (13.8 to 1035.6)232.3 (13.9 to 706.3)
2 - 4 HOURS POST497.2 (57.1 to 1027.4)257.7 (46.3 to 660.2)
4 - 8 HOURS POST427.5 (141.2 to 778.2)267.0 (NA to 339.6)
SecondaryPart 1 - Nifurtimox Concentration Over Time in Plasma at Visit 6

The evaluation was based on clinical examinations. Measured in sub-population.

Time frame:
At Visit 6 (Day 30): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours
Reported as:
Median · ug/L
Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 6
ug/LNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Predose23.8 (NA to 459.3)40.8 (NA to 284.3)
5 - 10 MIN POST71.7 (NA to 153.7)73.7 (NA to 266.7)
10 - 120 MIN POST135.0 (NA to 932.4)172.7 (14.1 to 387.3)
2 - 4 HOURS POST369.5 (92.1 to 1277.0)103.8 (12.3 to 1107.2)
4 - 8 HOURS POST249.7 (70.9 to 504.3)165.2 (84.9 to 1089.3)
SecondaryPart 1 - Nifurtimox Concentration Over Time in Plasma at Visit 8

Measured in sub-population.

Time frame:
At Visit 8 (Day 60): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours
Reported as:
Median · ug/L
Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 8
ug/LNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
PredoseNA (NA to 258.7)NA (NA to NA)
5 - 10 MIN POST92.4 (15.9 to 255.1)NA (NA to NA)
10 - 120 MIN POST139.1 (23.6 to 711.4)NA (NA to 21.5)
2 - 4 HOURS POST395.6 (166.9 to 883.0)NA (NA to NA)
4 - 8 HOURS POST300.6 (28.5 to 1217.2)NA (NA to NA)
SecondaryPart 2 - Incidence Rate of Seronegative Conversion in Subjects Who Received at Least One Dose of the 30-day Nifurtimox Treatment Regimen

Seronegative conversion measured by two types of assay (recombinant ELISA and indirect hemagglutination assay \[IHA\]) in subjects who were randomized and received at least one dose of the 30-day nifurtimox treatment regimen. Incidence rate is the number of new cases of seronegative conversion over the study period (i.e., 4 years after end of nifurtimox treatment) divided by the person-time at risk. It was modelled using a Poisson distribution with a 2-sided 95% exact CI. Number of participants with events were reported.

Time frame:
Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1
Reported as:
Number · Participants
Part 2 - Incidence Rate of Seronegative Conversion in Subjects Who Received at Least One Dose of the 30-day Nifurtimox Treatment Regimen
ParticipantsNifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Part 2 - Incidence Rate of Seronegative Conversion in Subjects Who Received at Least One Dose of the 30-day Nifurtimox Treatment Regimen8
Statistical analysis
  • Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2 · Risk ratio (rr): 2.11 · 95% CI 0.91 to 4.16Person-year = 379
SecondaryPart 2 - ECG Signs of Established Chagas-related Cardiomyopathy

Summary of subjects by evidence of established Chagas-related cardiomyopathy as measured by electrocardiogram (ECG). Evidence of established Chagas-related cardiomyopathy: Total

Time frame:
Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1
Reported as:
Number · Participants
Part 2 - ECG Signs of Established Chagas-related Cardiomyopathy
ParticipantsNifurtimox 60 Days: Chagas-related CardiomyopathyNifurtimox 30 Days: Chagas-related Cardiomyopathy
YES00
NO18990
MISSING88
SecondaryPart 2 - Serological Response of Established Chagas-related Cardiomyopathy

Summary of subjects by evidence of established Chagas-related cardiomyopathy as measured by Serological response. Evidence of established Chagas-related cardiomyopathy: Total

Time frame:
Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1
Reported as:
Number · Participants
Part 2 - Serological Response of Established Chagas-related Cardiomyopathy
ParticipantsNifurtimox 60 Days: Chagas-related CardiomyopathyNifurtimox 30 Days: Chagas-related Cardiomyopathy
Non Reactive146
Reactive17684
Missing78
SecondaryPart 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA

Summary and change from baseline of optical density values measured by total purified antigen ELISA. Optical density is the measure of absorbance, and is defined as the ratio of the intensity of light falling upon a material and the intensity transmitted.

Time frame:
Baseline and Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1
Reported as:
Mean · Optical density
Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA
Optical densityNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Part 1 - Baseline (Visit 1)1.47 ± 0.551.52 ± 0.55
Part 1 - Up to 420 days post-treatment (Visit 11)1.24 ± 0.621.30 ± 0.61
Part 1 - Change from Baseline (Visit 11)-0.24 ± 0.29-0.23 ± 0.41
Part 2 - Year 2: (FU Visit 1)1.23 ± 0.591.29 ± 0.61
Part 2 - Year 2: Change from Baseline (FU Visit 1)-0.25 ± 0.41-0.23 ± 0.49
Part 2 - Year 3 (FU Visit 3)1.16 ± 0.581.23 ± 0.58
Part 2 - Year 3: Change from Baseline (FU Visit 3)-0.30 ± 0.42-0.30 ± 0.50
Part 2 - Year 4 (FU Visit 5)1.12 ± 0.571.23 ± 0.59
Part 2 - Year 4: Change from Baseline (FU Visit 5)-0.35 ± 0.40-0.30 ± 0.46
SecondaryPart 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA

Summary and change from baseline of optical density values measured by recombinant ELISA. Optical density is the measure of absorbance, and is defined as the ratio of the intensity of light falling upon a material and the intensity transmitted.

Time frame:
Baseline and Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1
Reported as:
Mean · Optical density
Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA
Optical densityNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Part 1 - Baseline (Visit 1)2.74 ± 0.632.73 ± 0.63
Part 1 - Up to 420 days post-treatment (Visit 11)2.27 ± 0.982.31 ± 1.00
Part 1 - Change from Baseline (Visit 11)-0.47 ± 0.74-0.41 ± 0.79
Part 2 - Year 2: (FU Visit 1)2.5 ± 0.952.57 ± 0.88
Part 2 - Year 2: Change from Baseline (FU Visit 1)-0.23 ± 0.87-0.17 ± 0.90
Part 2 - Year 3 (FU Visit 3)2.17 ± 0.982.25 ± 0.91
Part 2 - Year 3: Change from Baseline (FU Visit 3)-0.56 ± 0.86-0.45 ± 0.87
Part 2 - Year 4 (FU Visit 5)2.09 ± 1.012.22 ± 1.00
Part 2 - Year 4: Change from Baseline (FU Visit 5)-0.64 ± 0.89-0.48 ± 0.87
SecondaryPart 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 1

The evaluation was based on clinical examinations.

Time frame:
At Visit 1 (before treatment started)
Reported as:
Count of participants · Participants
Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 1
ParticipantsNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 120
SecondaryPart 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 3

The evaluation was based on clinical examinations.

Time frame:
Up to 7 days (Visit 3)
Reported as:
Count of participants · Participants
Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 3
ParticipantsNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Anemia10
Chagas disease20
Hepatomegaly10
Known ECG abnormality40
SecondaryPart 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 6

The evaluation was based on clinical examinations.

Time frame:
Up to 30 days (Visit 6)
Reported as:
Count of participants · Participants
Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 6
ParticipantsNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Known ECG abnormality10
Romana sign01
SecondaryPart 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 8

The evaluation was based on clinical examinations.

Time frame:
Up to 60 days (Visit 8; end of treatment)
Reported as:
Count of participants · Participants
Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 8
ParticipantsNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Anemia10
Chagas disease10
Known ECG abnormality10
Lymphadenopathy10
SecondaryPart 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 9

The evaluation was based on clinical examinations.

Time frame:
Up to 90 days (Visit 9 post-treatment)
Reported as:
Count of participants · Participants
Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 9
ParticipantsNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 910
SecondaryPart 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 10

The evaluation was based on clinical examinations.

Time frame:
Up to 240 days (Visit 10 post-treatment)
Reported as:
Count of participants · Participants
Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 10
ParticipantsNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 1010
SecondaryPart 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 11

The evaluation was based on clinical examinations.

Time frame:
Up to 420 days (Visit 11 post-treatment)
Reported as:
Count of participants · Participants
Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 11
ParticipantsNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 1133
SecondaryPart 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age)
Time frame:
Up to 90 days (Visit 9 post-treatment)
Reported as:
Count of participants · Participants
Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age)
ParticipantsNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Visit 1|Positive127
Visit 3|Positive11
Visit 6|Positive00
Visit 8|Positive00
Visit 9|Positive10
Visit 1|Negative00
Visit 3|Negative115
Visit 6|Negative127
Visit 8|Negative127
Visit 9|Negative117
Visit 1|Missing00
Visit 3|Missing01
Visit 6|Missing00
Visit 8|Missing00
Visit 9|Missing00
SecondaryPart 1 - Number of Subjects With a Positive Serological Response Using Non-conventional Enzyme-linked Immunosorbent Assay-F29 (ELISAF29) Test

The non-conventional ELISA-F29 test is considered an early marker of treatment efficacy in chronic Chagas disease.

Time frame:
Up to 420 days (Visit 11 post-treatment)
Reported as:
Count of participants · Participants
Part 1 - Number of Subjects With a Positive Serological Response Using Non-conventional Enzyme-linked Immunosorbent Assay-F29 (ELISAF29) Test
ParticipantsNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Reactive9654
Non-reactive11454
Missing93
SecondaryPart 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results

The qPCR is molecular technique, considered a tool to diagnose acute and congenital Chagas disease, as well as a marker to measure treatment failure when demonstrating positive (detectable) results

Time frame:
Up to 420 days (Visit 11 post-treatment)
Reported as:
Count of participants · Participants
Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results
ParticipantsNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Visit 1 - Non-detectable9953
Visit 1 - Detectable11757
Visit 1 - Non-evaluable11
Visit 1 - Missing20
Visit 3 - Non-detectable17186
Visit 3 - Detectable4621
Visit 3 - Non-evaluable01
Visit 3 - Missing23
Visit 6 - Non-detectable207105
Visit 6 - Detectable43
Visit 6 - Non-evaluable32
Visit 6 - Missing51
Visit 8 - Non-detectable210105
Visit 8 - Detectable31
Visit 8 - Non-evaluable22
Visit 8 - Missing43
Visit 10 - Non-detectable206105
Visit 10 - Detectable32
Visit 10 - Non-evaluable22
Visit 10 - Missing82
Visit 11 - Non-detectable205102
Visit 11 - Detectable35
Visit 11 - Non-evaluable11
Visit 11 - Missing103
SecondaryPart 1 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

TEAEs comprised events which first occurred or worsened at or after first application of study drug during the course of the study up to and including 7 days after last application of study drug

Time frame:
up to 7 days after last application of study drug
Reported as:
Count of participants · Participants
Part 1 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
ParticipantsNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Any treatment-emergent adverse event (TEAE)14766
Any Serious TEAE63
SecondaryPart 2 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

TEAEs comprised events which first occurred or worsened at study start up to end of study in part 2. In Part 2, only AEs considered at least possibly related to nifurtimox (administered in part 1) and those caused by protocol-related procedures were reported.

Time frame:
Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1
Reported as:
Count of participants · Participants
Part 2 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
ParticipantsNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Any AE00
Any study drug-related AE00
Any AE related to protocol00
Any SAE00
Any study drug-related SAE00
Any SAE related to protocol00
AE with outcome death00
SecondaryPart 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment

The Number Analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. The number of subjects represents subjects with at least one high laboratory assessment after start of treatment who had a normal or lower than normal laboratory assessment at baseline.

Time frame:
Up to 420 days (Visit 11 post-treatment)
Reported as:
Count of participants · Participants
Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment
ParticipantsNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Creatinine (mg/dL)32
Albumin (g/dL)4921
Alkaline Phosphatase (U/L)113
Alanine Aminotransferase (U/L)197
Aspartate Aminotransferase (U/L)277
Bilirubin (mg/dL)199
Direct Bilirubin (mg/dL)219
Blood Urea Nitrogen (mg/dL)113
Urate (mg/dL)71
Glucose (mg/dL)1513
Protein (g/dL)4214
SecondaryPart 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment

The number analyzed represents the number of subjects at baseline with a normal or higher than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. The number of subjects represents subjects with at least one low laboratory assessment after start of treatment who had a normal or higher than normal laboratory assessment at baseline.

Time frame:
Up to 420 days (Visit 11 post-treatment)
Reported as:
Count of participants · Participants
Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment
ParticipantsNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Creatinine (mg/dL)2210
Albumin (g/dL)144
Alkaline Phosphatase (U/L)44
Alanine Aminotransferase (U/L)63
Aspartate Aminotransferase (U/L)15
Bilirubin (mg/dL)73
Direct Bilirubin (mg/dL)00
Blood Urea Nitrogen (mg/dL)3115
Urate (mg/dL)3218
Glucose (mg/dL)2918
Protein (g/dL)1715
SecondaryPart 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment

The number analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. Subjects with missing or high abnormal values at baseline are not included in the number analyzed. The number of subjects represents subjects with at least one high laboratory assessment after start of treatment who had a normal or lower than normal laboratory assessment at baseline.

Time frame:
Up to 420 days (Visit 11 post-treatment)
Reported as:
Count of participants · Participants
Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment
ParticipantsNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Hematocrit (%198
Hemoglobin (g/dL)153
Erythrocytes (T/L) in Blood219
Ery. Mean Corpuscular Volume (fL) in Blood207
Ery. Mean Corpuscular Hemoglobin (pg) in Blood145
Ery. Mean Corpuscular HGB Conc. (g/dL) in Blood236
Leukocytes (GIGA/L) in Blood4116
Neutrophils/Leukocytes (%)3812
Neutrophils (GIGA/L)368
Lymphocytes/Leukocytes (%)3517
Lymphocytes (GIGA/L)217
Monocytes/Leukocytes (%)3317
Monocytes (GIGA/L)1715
Eosinophils/Leukocytes (%)5826
Eosinophils (GIGA/L)5322
Basophils/Leukocytes (%)207
Basophils (GIGA/L)102
Platelets (GIGA/L) in Blood2713
SecondaryPart 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment

The number analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. Subjects with missing or low abnormal values at baseline are not included in the number analyzed. The number of subjects represents subjects with at least one low laboratory assessment after start of treatment who had a normal or higher than normal laboratory assessment at baseline.

Time frame:
Up to 420 days (Visit 11 post-treatment)
Reported as:
Count of participants · Participants
Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment
ParticipantsNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Hematocrit (%3017
Hemoglobin (g/dL)2317
Erythrocytes (T/L) in Blood159
Ery. Mean Corpuscular Volume (fL) in Blood166
Ery. Mean Corpuscular Hemoglobin (pg) in Blood1910
Ery. Mean Corpuscular HGB Conc. (g/dL) in Blood2921
Leukocytes (GIGA/L) in Blood3918
Neutrophils/Leukocytes (%)5327
Neutrophils (GIGA/L)4625
Lymphocytes/Leukocytes (%)409
Lymphocytes (GIGA/L)50
Monocytes/Leukocytes (%)5428
Monocytes (GIGA/L)3322
Eosinophils/Leukocytes (%)135
Eosinophils (GIGA/L)145
Basophils/Leukocytes (%)12
Basophils (GIGA/L)12
Platelets (GIGA/L) in Blood63
SecondaryPart 1 - Number of Subjects With Treatment-emergent High Coagulation Abnormalities by Treatment

The Number Analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. The number of subjects represents subjects with at least one high laboratory assessment after start of treatment who had a normal or lower than normal laboratory assessment at baseline.

Time frame:
Up to 420 days (Visit 11 post-treatment)
Reported as:
Count of participants · Participants
Part 1 - Number of Subjects With Treatment-emergent High Coagulation Abnormalities by Treatment
ParticipantsNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Prothrombin Time (sec) in Plasma3823
Activated Partial Thromboplastin910
Time in Plasma Prothrombin Intl. Normalized Ratio2113
SecondaryPart 1 - Number of Subjects With Treatment-emergent Low Coagulation Abnormalities by Treatment

The number analyzed represents the number of subjects at baseline with a normal or higher than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. The number of subjects represents subjects with at least one low laboratory assessment after start of treatment who had a normal or higher than normal laboratory assessment at baseline.

Time frame:
Up to 420 days (Visit 11 post-treatment)
Reported as:
Count of participants · Participants
Part 1 - Number of Subjects With Treatment-emergent Low Coagulation Abnormalities by Treatment
ParticipantsNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Prothrombin Time (sec) in Plasma105
Activated Partial Thromboplastin152
Time in Plasma Prothrombin Intl. Normalized Ratio145
SecondaryPart 1 - Number of Subjects With Abnormal Urinalysis Findings Considered as Clinically Significant or Reported as Adverse Events (AEs)

Urinalysis was performed and the following parameters evaluated: bilirubin, blood (red blood cells, white blood cells), chorionic gonadotropin β, glucose, ketones, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen.

Time frame:
Up to 420 days (Visit 11 post-treatment)
Reported as:
Count of participants · Participants
Part 1 - Number of Subjects With Abnormal Urinalysis Findings Considered as Clinically Significant or Reported as Adverse Events (AEs)
ParticipantsNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Part 1 - Number of Subjects With Abnormal Urinalysis Findings Considered as Clinically Significant or Reported as Adverse Events (AEs)00
SecondaryPart 1 - Number of Subjects With Abnormal ECG Findings Considered as Clinically Significant by Investigators

Clinical significance of abnormal ECG was based on the judgement of the investigator

Time frame:
Up to 420 days (Visit 11 post-treatment)
Reported as:
Count of participants · Participants
Part 1 - Number of Subjects With Abnormal ECG Findings Considered as Clinically Significant by Investigators
ParticipantsNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
Part 1 - Number of Subjects With Abnormal ECG Findings Considered as Clinically Significant by Investigators00
SecondaryPart 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline

Systolic Blood Pressure

Time frame:
Baseline and up to 420 days (Visit 11 post-treatment)
Reported as:
Mean · mmHg
Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline
mmHgNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
VISIT 11.09 ± 7.790.69 ± 7.85
VISIT 2-3.75 ± 7.50-5.00 ± 7.07
VISIT 31.08 ± 9.98-0.50 ± 8.45
VISIT 6-0.74 ± 10.70-1.12 ± 9.89
VISIT 8-0.41 ± 11.010.48 ± 11.24
VISIT 9-0.13 ± 11.11-0.45 ± 10.49
VISIT 10-0.02 ± 10.46-1.48 ± 10.95
VISIT 111.20 ± 11.521.57 ± 10.70
SecondaryPart 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline

Diastolic Blood Pressure

Time frame:
Baseline and up to 420 days (Visit 11 post-treatment)
Reported as:
Mean · mmHg
Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline
mmHgNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
VISIT 11.00 ± 7.720.90 ± 7.90
VISIT 2-1.25 ± 2.50-1.00 ± 2.00
VISIT 30.76 ± 8.360.26 ± 8.05
VISIT 60.26 ± 10.87-0.14 ± 10.21
VISIT 80.08 ± 9.910.93 ± 10.17
VISIT 9-0.68 ± 8.81-0.21 ± 10.03
VISIT 100.99 ± 9.900.85 ± 9.53
VISIT 112.30 ± 11.063.25 ± 10.95
SecondaryPart 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline

Respiratory Rate

Time frame:
Baseline and up to 420 days (Visit 11 post-treatment)
Reported as:
Mean · BREATHS/MIN
Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline
BREATHS/MINNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
VISIT 10.12 ± 4.100.47 ± 2.91
VISIT 2-1.50 ± 3.42-1.00 ± 1.15
VISIT 3-0.05 ± 3.15-0.14 ± 3.91
VISIT 6-0.57 ± 4.16-0.06 ± 3.87
VISIT 8-0.77 ± 4.040.04 ± 4.58
VISIT 9-1.01 ± 4.06-0.50 ± 3.76
VISIT 10-1.36 ± 4.50-0.24 ± 3.60
VISIT 11-1.93 ± 5.10-0.74 ± 4.61
SecondaryPart 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline

Heart Rate

Time frame:
Baseline and up to 420 days (Visit 11 post-treatment)
Reported as:
Mean · BEATS/MIN
Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline
BEATS/MINNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
VISIT 1-1.08 ± 10.190.26 ± 11.37
VISIT 2-6.75 ± 2.22-0.75 ± 2.99
VISIT 30.04 ± 10.11-0.51 ± 11.46
VISIT 6-0.78 ± 11.49-0.75 ± 11.92
VISIT 8-1.27 ± 11.65-1.34 ± 11.03
VISIT 9-1.26 ± 11.97-1.63 ± 10.56
VISIT 10-3.28 ± 11.87-3.28 ± 11.61
VISIT 11-3.57 ± 12.57-4.66 ± 14.73
SecondaryPart 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline

Temperature

Time frame:
Baseline and up to 420 days (Visit 11 post-treatment)
Reported as:
Mean · °C
Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline
°CNifurtimox 60 Days / Arm 1Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2
VISIT 10.01 ± 0.390.04 ± 0.36
VISIT 2-0.35 ± 0.45-0.03 ± 0.39
VISIT 3-0.10 ± 0.360.04 ± 0.43
VISIT 6-0.06 ± 0.440 ± 0.44
VISIT 8-0.06 ± 0.450.05 ± 0.42
VISIT 9-0.03 ± 0.440.02 ± 0.47
VISIT 10-0.07 ± 0.49-0.01 ± 0.52
VISIT 11-0.14 ± 0.51-0.10 ± 0.50
Other pre-specifiedPart 1: Number of Participants Cured With 60-day Regimen Compared With Historical Active Control (Benznidazole)

This exploratory efficacy analysis evaluated the cure rate assessed as seroconversion of nifurtimox after 1-year post-treatment follow-up with that of published data for benznidazole (Sosa Estani et al. 1998 and de Andrade et al. 1996) at 4- and 3-year post-treatment follow-up, respectively, used as historical control.

Time frame:
Up to 420 days (Visit 11 post-treatment)
Reported as:
Count of participants · Participants
Part 1: Number of Participants Cured With 60-day Regimen Compared With Historical Active Control (Benznidazole)
ParticipantsNifurtimox 60 Days / Arm 1
Part 1: Number of Participants Cured With 60-day Regimen Compared With Historical Active Control (Benznidazole)10
Other pre-specifiedPart 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit

Using frequencies of matches and mismatches to assess agreement Reactive = Reac ELISA Detectable = Detec qPCR Non-reactive = Nonreac ELISA Non-detectable = Nondetec qPCR Non evaluable = Noneval qPCR qPCR Missing = Miss qPCR Missing conventional testing = Miss ELISA

Time frame:
Up to 420 days (Visit 11 post-treatment)
Reported as:
Count of participants · Participants
Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and qPCR Testing by Visit
ParticipantsNifurtimox 60 Days Reactive DetectableNifurtimox 60 Days Reactive Non-detectableNifurtimox 60 Days Non-reactive DetectableNifurtimox 60 Days Non-reactive Non-detectableNifurtimox 60 Days Reactive Non EvaluableNifurtimox 60 Days Reactive qPCR MissingNifurtimox 30 Days Reactive DetectableNifurtimox 30 Days Reactive Non-detectableNifurtimox 30 Days Non-reactive DetectableNifurtimox 30 Days Non-reactive Non-detectableNifurtimox 30 Days Reactive Non EvaluableNifurtimox 30 Days Missing Conventional Testing Non-detectable
Visit 111799001257520110
Visit 83210002011030121
Visit 103195011202990620
Visit 113194011115960610
Other pre-specifiedPart 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit

Using frequencies of matches and mismatches to assess agreement Reactive = Reac ELISA Reactive = Reac F29 Non-reactive = Nonreac ELISA Non-reactive = Nonreac F29

Time frame:
Up to 420 days (Visit 11 post-treatment)
Reported as:
Count of participants · Participants
Part 1 - Relationship of Conventional Serology (Total Purified Antigen ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit
ParticipantsNifurtimox 60 Days Reactive and ReactiveNifurtimox 60 Days Reactive and Non-reactiveNifurtimox 60 Days Non-reactive and ReactiveNifurtimox 60 Days Non-reactive and Non-reactiveNifurtimox 30 Days Reactive and ReactiveNifurtimox 30 Days Reactive and Non-reactiveNifurtimox 30 Days Non-reactive and ReactiveNifurtimox 30 Days Non-reactive and Non-reactive
Visit 11427700723801
Visit 31338500644301
Visit 61318300674201
Visit 812491063634301
Visit 101089229614206
Visit 119310638544806
Other pre-specifiedPart 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit

Using frequencies of matches and mismatches to assess agreement Reactive = Reac ELISA Reactive = Reac F29 Non-reactive = Nonreac ELISA Non-reactive= Nonreac F29

Time frame:
Up to 420 days (Visit 11 post-treatment)
Reported as:
Count of participants · Participants
Part 1 - Relationship of Conventional Serology (Recombinant ELISA) and Non-conventional (ELISA-F29) Serologic Testing by Visit
ParticipantsNifurtimox 60 Days Reactive and ReactiveNifurtimox 60 Days Reactive and Non-reactiveNifurtimox 60 Days Non-reactive and ReactiveNifurtimox 60 Days Non-reactive and Non-reactiveNifurtimox 30 Days Reactive and ReactiveNifurtimox 30 Days Non-reactive and ReactiveNifurtimox 30 Days Non-reactive and Non-reactive
Visit 114277007201
Visit 313385006401
Visit 613181026701
Visit 812490016301
Visit 10108912105925
Visit 1193106305316
Other pre-specifiedPart 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results

Sero-reduction is defined as a =\> 20% reduction in optical density \[OD\]) using two conventional ELISA serology tests in subjects =\> 8 months to \< 18 years of age at randomization; Others: reactive results that are not sero-reduction in subjects =\> 8 months to \< 18 years of age at randomization; or reactive results in subjects \< 8 months of age at randomization. Non-reactive ELISA = Nonreac ELISA Non-reactive IHA = Nonreac IHA Reactive IHA decrease = Reac IHA dec React IHA nochange = Reac IHA nochange Reactive ELISA: seroreduction = Reac ELISA reduc Reactive ELISA: others = Reac ELISA other

Time frame:
Up to 420 days (Visit 11 post-treatment)
Reported as:
Count of participants · Participants
Part 1 - Relationship of Conventional Serology (ELISA) to Indirect Hemagglutination Assay (IHA) Results
ParticipantsNon-reactive ELISA and Non-reactive IHANon-reactive ELISA and Reactive IHA DecreaseNon-react ELISA and React IHA NochangeReactive ELISA: Sero-reduction and Non-react IHAReactive ELISA: Sero Reduction and Reactive IHA DecreaseReactive ELISA: Sero-reduction and Reactive IHA NochangeReactive ELISA: Others and Non-reactive IHAReactive ELISA: Others and React IHA DecreaseReactive ELISA: Others and React IHA NochangeReactive ELISA: Others and Missing IHA
Nifurtimox 60 days82024020147891
Nifurtimox 30 days4100124130580
Other pre-specifiedPart 1 - Relationship Between Conventional ELISA Results in Terms of Cure or No Cure and IHA Results in All Patients

Cure is defined as sero-reduction (in subjects =\> 8 months to \< 18 years of age at randomization) or sero-conversion (in all subjects). Sero-reduction is defined as a =\> 20% reduction in optical density \[OD\]) measured by two conventional ELISA serology tests and sero-conversion is defined as negative Immunoglobulin G \[IgG\] concentration measured by two conventional ELISA serology tests. Cure = Cure Non reactive/reactive decreasing = Nonreac/reac dec Reactive non-decreasing = Reac nondec No cure = No Cure Missing IHA testing = IHA missing

Time frame:
Up to 420 days (Visit 11 post-treatment)
Reported as:
Count of participants · Participants
Part 1 - Relationship Between Conventional ELISA Results in Terms of Cure or No Cure and IHA Results in All Patients
ParticipantsCure and Non Reactive/Reactive DecreasingCure and Reactive Non-decreasingNo Cure and Non Reactive/Reactive DecreasingNo Cure and Reactive Non-decreasingNo Cure and Missing IHA Testing
Nifurtimox 60 days522048891
Nifurtimox 30 days17429580

Adverse events

Collected over Part 1: From first application of study drug up to and including 7 days after last application of study drug Part 2: first occurred or worsened at start of study part 2 up to 3 years.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Nifurtimox 60-day Regimen0/219 (0%)6/219 (2.7%)128/219 (58.4%)
Nifurtimox 30-day Regimen0/111 (0%)3/111 (2.7%)51/111 (45.9%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventNifurtimox 60-day RegimenNifurtimox 30-day Regimen
SeizureNervous system disorders2/2190/111
Ear infectionInfections and infestations0/2191/111
GastroenteritisInfections and infestations0/2191/111
PneumoniaInfections and infestations0/2191/111
Febrile convulsionNervous system disorders0/2191/111
Abortion inducedSurgical and medical procedures0/2191/111
Abdominal painGastrointestinal disorders1/2191/111
CellulitisInfections and infestations1/2190/111
Chronic tonsillitisInfections and infestations1/2190/111
Pelvic inflammatory diseaseInfections and infestations1/2190/111
Most frequent other events
Showing 10 of 12
Most frequent other events
EventNifurtimox 60-day RegimenNifurtimox 30-day Regimen
VomitingGastrointestinal disorders33/21910/111
HeadacheNervous system disorders30/21916/111
NauseaGastrointestinal disorders19/21914/111
Decreased appetiteMetabolism and nutrition disorders25/2198/111
NasopharyngitisInfections and infestations22/21911/111
PyrexiaGeneral disorders20/2194/111
Abdominal painGastrointestinal disorders19/2199/111
DiarrhoeaGastrointestinal disorders16/2196/111
Abdominal pain upperGastrointestinal disorders15/2194/111
PharyngitisInfections and infestations13/2191/111

Baseline characteristics

Age, Customized
Age, Customized(Participants)Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2Nifurtimox 60 Days / Arm 1Total
0 to 27 days347
28 days to younger than 8 months4812
8 months to younger than 2 years81725
2 years to younger than 18 years96190286
Sex: Female, Male
Sex: Female, Male(Participants)Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2Nifurtimox 60 Days / Arm 1Total
Female59119178
Male52100152
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2Nifurtimox 60 Days / Arm 1Total
White81155236
American Indian or Alaska native306494
Total Purified Antigen enzyme-linked immunosorbent assay (ELISA) test results
Total Purified Antigen enzyme-linked immunosorbent assay (ELISA) test results(Participants)Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2Nifurtimox 60 Days / Arm 1Total
Reactive110219329
Non Reactive101
Total Purified Antigen ELISA optical density (OD) values
Total Purified Antigen ELISA optical density (OD) values(No dimension)Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2Nifurtimox 60 Days / Arm 1Total
Mean1.532 ± 0.5331.474 ± 0.5531.494 ± 0.546
Recombinant ELISA test results
Recombinant ELISA test results(Participants)Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2Nifurtimox 60 Days / Arm 1Total
Reactive110219329
Non Reactive101
Recombinant ELISA OD values
Recombinant ELISA OD values(No dimension)Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2Nifurtimox 60 Days / Arm 1Total
Mean2.765 ± 0.6052.735 ± 0.6402.745 ± 0.628
Non conventional ELISA-F29 test results
Non conventional ELISA-F29 test results(Participants)Nifurtimox 30 Days, Then Placebo 30 Days / Arm 2Nifurtimox 60 Days / Arm 1Total
Reactive72142214
Non Reactive3977116

2 further baseline measures are reported on the registry.

08

Study locations

25 sites
  • La Plata, Buenos Aires 1900, Argentina
  • Buenos Aires, Ciudad Auton. De Buenos Aires 1281, Argentina
  • Buenos Aires, Ciudad Auton. De Buenos Aires C1270AAN, Argentina
  • Buenos Aires, Ciudad Auton. De Buenos Aires C1425AGP, Argentina
  • Buenos Aires, Ciudad Auton. De Buenos Aires C1425EFD, Argentina
  • San Salvador de Jujuy, Jujuy 4600, Argentina
  • Posadas, Misiones, Argentina
  • Rosario, Santa Fe 2000, Argentina
  • Corrientes, W3400CBI, Argentina
  • Formosa, P3600HZL, Argentina
  • La Rioja, Argentina
  • Mendoza, 5500, Argentina
  • Mendoza, 5535, Argentina
  • Salta, 4400, Argentina
  • Salta, A4400ESE, Argentina
  • San Juan, 5400, Argentina
  • Santiago del Estero, 4202, Argentina
  • Tucuman, 4000, Argentina
  • Cochabamba, Bolivia
  • Punata, Bolivia
  • Tarija, Bolivia
  • Soledad, Atlántico, Colombia
  • Yopal, Casanare 0, Colombia
  • Santa Marta, Magdalena 0, Colombia
  • Floridablabca, Santander 681011, Colombia
09

References and documents

Publications

  • Sosa Estani S, Segura EL, Ruiz AM, Velazquez E, Porcel BM, Yampotis C. Efficacy of chemotherapy with benznidazole in children in the indeterminate phase of Chagas' disease. Am J Trop Med Hyg. 1998 Oct;59(4):526-9. doi: 10.4269/ajtmh.1998.59.526. PubMed 9790423 ↗
  • de Andrade AL, Zicker F, de Oliveira RM, Almeida Silva S, Luquetti A, Travassos LR, Almeida IC, de Andrade SS, de Andrade JG, Martelli CM. Randomised trial of efficacy of benznidazole in treatment of early Trypanosoma cruzi infection. Lancet. 1996 Nov 23;348(9039):1407-13. doi: 10.1016/s0140-6736(96)04128-1. PubMed 8937280 ↗
  • Altcheh J, Castro L, Dib JC, Grossmann U, Huang E, Moscatelli G, Pinto Rocha JJ, Ramirez TE; CHICO Study Group. Prospective, historically controlled study to evaluate the efficacy and safety of a new paediatric formulation of nifurtimox in children aged 0 to 17 years with Chagas disease one year after treatment (CHICO). PLoS Negl Trop Dis. 2021 Jan 7;15(1):e0008912. doi: 10.1371/journal.pntd.0008912. eCollection 2021 Jan. PubMed 33412557 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02625974
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Dec 9, 2015
Start date
Jan 27, 2016
Primary completion
Jul 25, 2018
Completion
Aug 10, 2021
Results posted
Oct 29, 2019
Last update
Aug 19, 2024

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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