A Phase 3 interventional study of Fexinidazole in Trypanosomiasis, African, Sleeping Sickness and Trypanosomiasis; Gambian, sponsored by Drugs for Neglected Diseases. Completed at 8 sites in 2 countries. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2025-01-08.
Sponsored by Drugs for Neglected Diseases · Phase 3, Interventional, and Treatment
This study evaluates the effectiveness of fexinidazole administered to patients with human African trypanosomiasis due to T. b. gambiense (g-HAT) at all stages of the disease. The aim of the present study is to provide additional information on the effectiveness and safety of fexinidazole and to assess its use under conditions as close as possible to those in real life, both in patients treated on an out-patient basis and in the hospital setting, depending on clinical status.
Participants will receive fexinidazole oral treatment for 10 days. Regular blood draws and lumbar punctures will be performed over 18 months to confirm the cure of the disease. Other assessments will include the recording of adverse events, signs and symptoms of the disease, laboratory tests, vital signs, electrocardiograms. Treatment compliance, feasibility, and packaging acceptability will be thoroughly assessed in the participants receiving treatment at home. Those participants will complete questionnaires to check that instructions for fexinidazole administration are clear enough and followed correctly.
See attached protocol.
26 studies on the registry are indexed under Trypanosomiasis, African; 1 is open to participants now.
This study's enrollment of 174 is above the median of 155 across 24 interventional studies indexed under Trypanosomiasis, African.
Browse Trypanosomiasis, African studies →Drugs for Neglected Diseases is the lead sponsor of 58 studies on the registry; 3 are open to participants now.
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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.
Exclusion Criteria:
elevated creatinine at > 3 times the (ULN); elevated alanine aminotranferase (), aspartate aminotransferase (AST), or at > 3 ULN
Temporary Non-inclusion Criteria:
Eligibility Criteria for Out-patient Treatment
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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.
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.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants received fexinidazole orally for 10 days as inpatients (at the hospital)
Drug: Fexinidazole
Participants received fexinidazole orally for 10 days as outpatients (at home)
Drug: Fexinidazole
Tablets of 600 mg; Participants with a weight between 20 and 34 kg received 1200 mg (2 tablets) for 4 days, then 600 mg (1 tablet) for 6 days (with food); Participants with a weight of 35 kg and above received 1800 mg (3 tablets) for 4 days, then 1200 mg (2 tablets) for 6 days (with food)
Percentage of Participants Whose Treatment Outcome at Month 18 is a Success
Treatment outcome at Month 18 is categorized as success or failure. Success is defined as a cure, according to the criteria adapted from the World Health Organization (WHO) update of the methodological framework for clinical trials in Sept 2014 (WHO/HTM/NTD/IDM/2015.5). Failure is defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the Month 18 visit, an unfavorable outcome earlier than Month 18, or signs and symptoms evoking a relapse at Month 18. Success rate at Month 18 is defined as the percentage of participants (regardless of g-HAT stage) whose treatment outcome is a success at Month 18. An estimate of the success rate at Month 18 and the 95% exact Clopper-Pearson confidence interval (CI) of the estimate are provided.
Time frame: Between the first intake of fexinidazole (Day 1) and the end of the follow-up period (18 months)
Percentage of Participants Whose Treatment Outcome at Month 12 is a Success
Treatment outcome at Month 12 is categorized as success or failure. Success is defined as a cure, according to the criteria adapted from the World Health Organization (WHO) update of the methodological framework for clinical trials in Sept 2014 (WHO/HTM/NTD/IDM/2015.5). Failure is defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the Month 12 visit, an unfavorable outcome earlier than Month 12, or signs and symptoms evoking a relapse at Month 12 (data collected at Month 18 are considered, if available). Success rate at Month 12 is defined as the percentage of participants (regardless of g-HAT stage) whose treatment outcome is a success at Month 12. An estimate of the success rate at Month 12 and the 95% exact Clopper-Pearson confidence interval (CI) of the estimate are provided.
Time frame: Between the first intake of fexinidazole (Day 1) and the end of the follow-up period (18 months)
Number of Participants With Any Grade ≥ 3 Treatment-emergent Adverse Events (AEs) Including Laboratory and Hematological Abnormalities (if Considered Clinically Significant)
AE severity is graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for AEs (CTCAE), Version 4.03 and, for certain laboratory parameters, modified CTCAE is used. Grade ≥3 AEs include the following events: Grade 3 events (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living), Grade 4 events (life-threatening consequences; urgent intervention indicated), and Grade 5 events (death related to AE). The observation period extends from the first intake of fexinidazole (Day 1) until the end-of-hospitalization visit (between Day 13 and Day 18) for inpatients and until the end-of-treatment visit (on Day 11) for outpatients.
Time frame: Between the first intake of fexinidazole (Day 1) and the end of the observation period, or the end of the follow-up period (18 months) for non-serious AEs assessed as related to fexinidazole
Number of Participants With Any Treatment-emergent Serious Adverse Event (SAE)
An SAE was defined as any AE that: resulted in death; was life-threatening; required inpatient hospitalisation or prolongation of existing hospitalisation; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was an important medical event that was not immediately life-threatening or did not result in death, but that jeopardised the patient's safety or required an intervention to prevent one of the outcomes above. Patients treated on an outpatient basis who required hospitalisation, for whatever reason, underwent the same procedures as patients initially treated in hospital, up to the end of the hospitalisation period. During this period, and up to Day 13 or Day 18, the reasons for hospitalisation were not to be considered to be SAEs solely based on the criterion of hospitalisation, but could be considered to be SAEs based on other criteria.
Time frame: Between the first intake of fexinidazole (Day 1) and the end of the follow-up period (18 months)
Number of Participants With Any Temporary or Permanent Treatment Discontinuation (Inpatient or Outpatient) for Reasons Related to Safety
Number of patients who prematurely discontinued treatment (temporarily or permanently) for reasons related to safety (including overdose).
Time frame: Between the first intake (Day 1) and last intake of fexinidazole (Day 10, or Day 11 if re-administration occurred)
Number of Participants With Any Hospitalization for Reasons Related to Safety (Outpatients Only)
Number of outpatients who are hospitalized for reasons related to safety (including overdose). An outpatient is considered as "hospitalized for reasons related to safety" if he/she is initially planned to be treated as an outpatient but experiences an AE during the treatment period (Day 1 to Day 10) and is hospitalized during the treatment period.
Time frame: Between the first intake (Day 1) and last intake of fexinidazole (Day 10, or Day 11 if re-administration occurred)
Number of Participants With Any Permanent Treatment Discontinuation (Inpatient or Outpatient) for Reasons Related to Safety
Number of patients who prematurely discontinued treatment permanently for reasons related to safety (including overdose).
Time frame: Between the first intake (Day 1) and last intake of fexinidazole (Day 10, or Day 11 if re-administration occurred)
Number of Outpatients Who Were Compliant With the Full Course of the 10-day Treatment
Number of outpatients who completed the full course of the 10-day treatment. Full completion can be either completing the 10-day treatment in the outpatient setting, or starting treatment as an outpatient but finishing treatment at the hospital, for those who have to be hospitalized (for any reason). At Day 11, the participant and/or caregiver have to present the treatment packaging they received at study inclusion, and the investigator has to record if the treatment calendar was fully completed or not.
Time frame: Between the first intake (Day 1) and last intake of fexinidazole (Day 10, or Day 11 if re-administration occurred)
Number of Outpatients Who Were Compliant With the 10-day Treatment Posology, Including Taking the Correct Number of Tablets During the 2 Phases of Treatment and Taking Tablets All at Once Every Day, With Food and Without Any Interruption of Treatment
Number of patients whose response to the question "How did you take your treatment?" is correct, as determined by the study personnel leading the compliance interview at Day 11 (end-of-treatment visit). The expected answer for participants weighing 35 kg or more is: 2 phases. Day 1 to 4 = 3 tablets. Day 5 to 10 = 2 tablets. Tablets to be taken all at once during a meal. The expected answer for participants weighing less than 35 kg is: 2 phases. Day 1 to 4 = 2 tablets. Day 5 to 10 = 1 tablet. Tablets to be taken all at once during a meal. The answer is considered correct if the 4 key messages have been understood (treatment period composed of 2 phases, each with a different number of tablets to be taken; treatment to be taken for 10 days without interruption; tablets to be taken all at once every day; treatment to be taken during a meal)
Time frame: End-of-treatment visit (Day 11)
Feasibility of Self-management of Treatment Intake in Outpatients: Occurrence of Temporary Treatment Discontinuation
The occurrence of temporary treatment discontinuation is recorded at Day 11 (end-of-treatment visit) in the case report form by the study personnel (Section on feasibility, question "Was the treatment temporarily discontinued?). Occurrence is presented as the number of outpatients who temporarily discontinued their treatment.
Time frame: End-of-treatment visit (Day 11)
Feasibility of Self-management of Treatment Intake in Outpatients: Occurrence of Permanent Treatment Discontinuation
The occurrence of permanent treatment discontinuation is recorded at Day 11 (end-of-treatment visit) in the case report form by the study personnel (Section on feasibility, question "Was the treatment stopped permanently?). Occurrence is presented as the number of outpatients who prematurely (prior to Day 10) discontinued their treatment permanently.
Time frame: End-of-treatment visit (Day 11)
Feasibility of Self-management of Treatment Intake in Outpatients: Delayed Treatment Start
The occurrence of delayed treatment start is recorded at Day 11 (end-of-treatment visit) in the case report form by the study personnel (Section on feasibility, date of first administration \[Day 1\] minus date of dispensing \[Day 0\] \> 1 day). The occurrence of delayed treatment start is presented as the number of outpatients who had their planned treatment start delayed by at least 1 day.
Time frame: End-of-treatment visit (Day 11)
Feasibility of Self-management of Treatment Intake in Outpatients: Hospitalization During the Treatment Period Due to Non-compliance
The occurrence of hospitalization is recorded at Day 11 (end-of-treatment visit) in the case report form by the study personnel (Section on feasibility, question "Did the patient finish his/her treatment in hospital?"), with "non-compliance" as the reason for hospitalization. Occurrence of hospitalization is presented as the number of outpatients who had to be hospitalized during the treatment period due to non-compliance.
Time frame: End-of-treatment visit (Day 11)
Acceptability of Packaging in Outpatients: Full Understanding of Instructions Concerning Dosing Regimen
Full understanding of the instructions concerning the dosing regimen of fexinidazole is assessed at Day 0 (day of treatment dispensing) by the study personnel. During the interview, the study personnel ask the participant and/or caregiver 8 questions about posology. To each of these 8 questions, the study personnel tick 'Yes' if the immediate answer is consistent with the expected answer. Full understanding of the instructions requires all 8 questions to be answered correctly. Full understanding is presented as the number of patients who correctly answered all 8 questions.
Time frame: Before treatment (Day 0)
Acceptability of Packaging in Outpatients: Help Requested to Follow the Treatment
Acceptability of packaging is assessed at Day 11 (end-of-treatment visit) by a questionnaire filled out by the participant and/or caregiver. The occurrence of help needed is presented as the number of outpatients who indicate at the end of treatment that they had to request help to follow the treatment (Section on acceptability, question "Did you have to request help to follow the treatment?").
Time frame: End-of-treatment visit (Day 11)
Acceptability of Packaging in Outpatients: Instructions Found Helpful
Acceptability of packaging is assessed at Day 11 (end-of-treatment visit) by a questionnaire filled out by the participant and/or caregiver. The number of patients who found the instructions helpful is recorded (Section on acceptability, question "Did you find the instruction sheet provided with the medication helpful / Did it help you to remember the important information?").
Time frame: End-of-treatment visit (Day 11)
Whole Blood Concentration of Fexinidazole From Dry Blood Spot, Measured 24 Hours After the Last Dose of Fexinidazole
Concentrations of fexinidazole is determined using a validated analytical method, in all patients with available PK data.
Time frame: End-of-treatment visit (Day 11, 24 hours after last treatment administration)
Whole Blood Concentration of Fexinidazole Metabolite M1 From Dry Blood Spot, Measured 24 Hours After the Last Dose of Fexinidazole
Concentrations of fexinidazole metabolite M1 (fexinidazole sulfoxide) is determined using a validated analytical method, in all patients with available PK data.
Time frame: End-of-treatment visit (Day 11, 24 hours after last treatment administration)
Whole Blood Concentration of Fexinidazole Metabolite M2 From Dry Blood Spot, Measured 24 Hours After the Last Dose of Fexinidazole
Concentrations of fexinidazole metabolite M2 (fexinidazole sulfone) is determined using a validated analytical method, in all patients with available PK data.
Time frame: End-of-treatment visit (Day 11, 24 hours after last treatment administration)
The study was conducted at 8 centers in the Democratic Republic of Congo and 1 center in Guinea. 200 participants were screened and signed informed consent. 3 patients had no trypanosomes in their blood and were not included since g-HAT positivity could not be confirmed. Of the 197 screened HAT-positive participants, 174 were included and treated, and 23 were not included, mainly due to inclusion/exclusion criteria not met. Participants were enrolled between 10 November 2016 and 10 August 2019.
| Milestone | Inpatients | Outpatients |
|---|---|---|
| Started | 136 | 38 |
| Completed | 129 | 35 |
| Not completed | 7 | 3 |
| Withdrew: Lack of efficacy | 6 | 1 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Withdrawal by subject | 0 | 2 |
Treatment outcome at Month 18 is categorized as success or failure. Success is defined as a cure, according to the criteria adapted from the World Health Organization (WHO) update of the methodological framework for clinical trials in Sept 2014 (WHO/HTM/NTD/IDM/2015.5). Failure is defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the Month 18 visit, an unfavorable outcome earlier than Month 18, or signs and symptoms evoking a relapse at Month 18. Success rate at Month 18 is defined as the percentage of participants (regardless of g-HAT stage) whose treatment outcome is a success at Month 18. An estimate of the success rate at Month 18 and the 95% exact Clopper-Pearson confidence interval (CI) of the estimate are provided.
| percentage of participants | All Treated Patients, Regardless of Treatment Setting |
|---|---|
| Percentage of Participants Whose Treatment Outcome at Month 18 is a Success | 93.1 (88.3 to 96.4) |
Treatment outcome at Month 12 is categorized as success or failure. Success is defined as a cure, according to the criteria adapted from the World Health Organization (WHO) update of the methodological framework for clinical trials in Sept 2014 (WHO/HTM/NTD/IDM/2015.5). Failure is defined as a relapse, probable relapse, death, use of rescue medication, loss to follow-up, refusal of all post-treatment lumbar puncture, and, in the absence of lumbar puncture at the Month 12 visit, an unfavorable outcome earlier than Month 12, or signs and symptoms evoking a relapse at Month 12 (data collected at Month 18 are considered, if available). Success rate at Month 12 is defined as the percentage of participants (regardless of g-HAT stage) whose treatment outcome is a success at Month 12. An estimate of the success rate at Month 12 and the 95% exact Clopper-Pearson confidence interval (CI) of the estimate are provided.
| percentage of participants | All Treated Patients, Regardless of Treatment Setting |
|---|---|
| Percentage of Participants Whose Treatment Outcome at Month 12 is a Success | 94.3 (89.7 to 97.2) |
AE severity is graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for AEs (CTCAE), Version 4.03 and, for certain laboratory parameters, modified CTCAE is used. Grade ≥3 AEs include the following events: Grade 3 events (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living), Grade 4 events (life-threatening consequences; urgent intervention indicated), and Grade 5 events (death related to AE). The observation period extends from the first intake of fexinidazole (Day 1) until the end-of-hospitalization visit (between Day 13 and Day 18) for inpatients and until the end-of-treatment visit (on Day 11) for outpatients.
| Participants | Inpatients | Outpatients |
|---|---|---|
| Number of Participants With Any Grade ≥ 3 Treatment-emergent Adverse Events (AEs) Including Laboratory and Hematological Abnormalities (if Considered Clinically Significant) | 10 | 4 |
An SAE was defined as any AE that: resulted in death; was life-threatening; required inpatient hospitalisation or prolongation of existing hospitalisation; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was an important medical event that was not immediately life-threatening or did not result in death, but that jeopardised the patient's safety or required an intervention to prevent one of the outcomes above. Patients treated on an outpatient basis who required hospitalisation, for whatever reason, underwent the same procedures as patients initially treated in hospital, up to the end of the hospitalisation period. During this period, and up to Day 13 or Day 18, the reasons for hospitalisation were not to be considered to be SAEs solely based on the criterion of hospitalisation, but could be considered to be SAEs based on other criteria.
| Participants | Inpatients | Outpatients |
|---|---|---|
| Number of Participants With Any Treatment-emergent Serious Adverse Event (SAE) | 10 | 4 |
Number of patients who prematurely discontinued treatment (temporarily or permanently) for reasons related to safety (including overdose).
| Participants | Inpatients | Outpatients |
|---|---|---|
| Number of Participants With Any Temporary or Permanent Treatment Discontinuation (Inpatient or Outpatient) for Reasons Related to Safety | 4 | 0 |
Number of outpatients who are hospitalized for reasons related to safety (including overdose). An outpatient is considered as "hospitalized for reasons related to safety" if he/she is initially planned to be treated as an outpatient but experiences an AE during the treatment period (Day 1 to Day 10) and is hospitalized during the treatment period.
| Participants | Outpatients |
|---|---|
| Number of Participants With Any Hospitalization for Reasons Related to Safety (Outpatients Only) | 2 |
Number of patients who prematurely discontinued treatment permanently for reasons related to safety (including overdose).
| Participants | Inpatients | Outpatients |
|---|---|---|
| Number of Participants With Any Permanent Treatment Discontinuation (Inpatient or Outpatient) for Reasons Related to Safety | 1 | 0 |
Number of outpatients who completed the full course of the 10-day treatment. Full completion can be either completing the 10-day treatment in the outpatient setting, or starting treatment as an outpatient but finishing treatment at the hospital, for those who have to be hospitalized (for any reason). At Day 11, the participant and/or caregiver have to present the treatment packaging they received at study inclusion, and the investigator has to record if the treatment calendar was fully completed or not.
| Participants | Outpatients |
|---|---|
| Number of Outpatients Who Were Compliant With the Full Course of the 10-day Treatment | 38 |
Number of patients whose response to the question "How did you take your treatment?" is correct, as determined by the study personnel leading the compliance interview at Day 11 (end-of-treatment visit). The expected answer for participants weighing 35 kg or more is: 2 phases. Day 1 to 4 = 3 tablets. Day 5 to 10 = 2 tablets. Tablets to be taken all at once during a meal. The expected answer for participants weighing less than 35 kg is: 2 phases. Day 1 to 4 = 2 tablets. Day 5 to 10 = 1 tablet. Tablets to be taken all at once during a meal. The answer is considered correct if the 4 key messages have been understood (treatment period composed of 2 phases, each with a different number of tablets to be taken; treatment to be taken for 10 days without interruption; tablets to be taken all at once every day; treatment to be taken during a meal)
| Participants | Outpatients |
|---|---|
| Number of Outpatients Who Were Compliant With the 10-day Treatment Posology, Including Taking the Correct Number of Tablets During the 2 Phases of Treatment and Taking Tablets All at Once Every Day, With Food and Without Any Interruption of Treatment | 35 |
The occurrence of temporary treatment discontinuation is recorded at Day 11 (end-of-treatment visit) in the case report form by the study personnel (Section on feasibility, question "Was the treatment temporarily discontinued?). Occurrence is presented as the number of outpatients who temporarily discontinued their treatment.
| Participants | Outpatients |
|---|---|
| Feasibility of Self-management of Treatment Intake in Outpatients: Occurrence of Temporary Treatment Discontinuation | 0 |
The occurrence of permanent treatment discontinuation is recorded at Day 11 (end-of-treatment visit) in the case report form by the study personnel (Section on feasibility, question "Was the treatment stopped permanently?). Occurrence is presented as the number of outpatients who prematurely (prior to Day 10) discontinued their treatment permanently.
| Participants | Outpatients |
|---|---|
| Feasibility of Self-management of Treatment Intake in Outpatients: Occurrence of Permanent Treatment Discontinuation | 0 |
The occurrence of delayed treatment start is recorded at Day 11 (end-of-treatment visit) in the case report form by the study personnel (Section on feasibility, date of first administration \[Day 1\] minus date of dispensing \[Day 0\] \> 1 day). The occurrence of delayed treatment start is presented as the number of outpatients who had their planned treatment start delayed by at least 1 day.
| Participants | Outpatients |
|---|---|
| Feasibility of Self-management of Treatment Intake in Outpatients: Delayed Treatment Start | 0 |
The occurrence of hospitalization is recorded at Day 11 (end-of-treatment visit) in the case report form by the study personnel (Section on feasibility, question "Did the patient finish his/her treatment in hospital?"), with "non-compliance" as the reason for hospitalization. Occurrence of hospitalization is presented as the number of outpatients who had to be hospitalized during the treatment period due to non-compliance.
| Participants | Outpatients |
|---|---|
| Feasibility of Self-management of Treatment Intake in Outpatients: Hospitalization During the Treatment Period Due to Non-compliance | 1 |
Full understanding of the instructions concerning the dosing regimen of fexinidazole is assessed at Day 0 (day of treatment dispensing) by the study personnel. During the interview, the study personnel ask the participant and/or caregiver 8 questions about posology. To each of these 8 questions, the study personnel tick 'Yes' if the immediate answer is consistent with the expected answer. Full understanding of the instructions requires all 8 questions to be answered correctly. Full understanding is presented as the number of patients who correctly answered all 8 questions.
| Participants | Outpatients |
|---|---|
| Acceptability of Packaging in Outpatients: Full Understanding of Instructions Concerning Dosing Regimen | 30 |
Acceptability of packaging is assessed at Day 11 (end-of-treatment visit) by a questionnaire filled out by the participant and/or caregiver. The occurrence of help needed is presented as the number of outpatients who indicate at the end of treatment that they had to request help to follow the treatment (Section on acceptability, question "Did you have to request help to follow the treatment?").
| Participants | Outpatients |
|---|---|
| Acceptability of Packaging in Outpatients: Help Requested to Follow the Treatment | 10 |
Acceptability of packaging is assessed at Day 11 (end-of-treatment visit) by a questionnaire filled out by the participant and/or caregiver. The number of patients who found the instructions helpful is recorded (Section on acceptability, question "Did you find the instruction sheet provided with the medication helpful / Did it help you to remember the important information?").
| Participants | Outpatients |
|---|---|
| Acceptability of Packaging in Outpatients: Instructions Found Helpful | 35 |
Concentrations of fexinidazole is determined using a validated analytical method, in all patients with available PK data.
| µg/mL | Inpatients | Outpatients |
|---|---|---|
| Whole Blood Concentration of Fexinidazole From Dry Blood Spot, Measured 24 Hours After the Last Dose of Fexinidazole | 0.048 (0.01 to 0.27) | 0.054 (0.01 to 0.18) |
Concentrations of fexinidazole metabolite M1 (fexinidazole sulfoxide) is determined using a validated analytical method, in all patients with available PK data.
| µg/mL | Inpatients | Outpatients |
|---|---|---|
| Whole Blood Concentration of Fexinidazole Metabolite M1 From Dry Blood Spot, Measured 24 Hours After the Last Dose of Fexinidazole | 1.928 (0.11 to 7.50) | 2.316 (0.13 to 4.41) |
Concentrations of fexinidazole metabolite M2 (fexinidazole sulfone) is determined using a validated analytical method, in all patients with available PK data.
| µg/mL | Inpatients | Outpatients |
|---|---|---|
| Whole Blood Concentration of Fexinidazole Metabolite M2 From Dry Blood Spot, Measured 24 Hours After the Last Dose of Fexinidazole | 11.014 (3.54 to 33.30) | 11.725 (2.55 to 35.86) |
Collected over Per protocol, non-serious adverse events (AEs) were recorded as follows: for inpatients, from the first intake of fexinidazole (Day 1) until the end-of-hospitalization Visit (Day 13-18) and in outpatients, from the first intake of fexinidazole (Day 1) until the end-of-treatment Visit (Day 11). Treatment-emergent serious AEs were collected from the first intake of fexinidazole (Day 1) until the end of the follow-up (Month 18). The population of analysis corresponds to the mITT population.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Inpatients | 1/136 (0.7%) | 10/136 (7.4%) | 73/136 (53.7%) |
| Outpatients | 0/38 (0%) | 4/38 (10.5%) | 23/38 (60.5%) |
| Event | Inpatients | Outpatients |
|---|---|---|
| AppendicitisInfections and infestations | 0/136 | 1/38 |
| CholeraInfections and infestations | 0/136 | 1/38 |
| MalariaInfections and infestations | 2/136 | 1/38 |
| Confusional statePsychiatric disorders | 0/136 | 1/38 |
| EpilepsyNervous system disorders | 2/136 | 0/38 |
| Tuberculous pleurisyInfections and infestations | 1/136 | 0/38 |
| Uterine ruptureInjury, poisoning and procedural complications | 1/136 | 0/38 |
| StarvationMetabolism and nutrition disorders | 1/136 | 0/38 |
| Psychomotor hyperactivityNervous system disorders | 1/136 | 0/38 |
| Psychomotor skills impairedNervous system disorders | 1/136 | 0/38 |
| Event | Inpatients | Outpatients |
|---|---|---|
| VomitingGastrointestinal disorders | 35/136 | 6/38 |
| HeadacheNervous system disorders | 24/136 | 8/38 |
| NauseaGastrointestinal disorders | 20/136 | 7/38 |
| InsomniaPsychiatric disorders | 12/136 | 7/38 |
| AstheniaGeneral disorders | 22/136 | 1/38 |
| PyrexiaGeneral disorders | 16/136 | 3/38 |
| TremorNervous system disorders | 0/136 | 4/38 |
| Decreased appetiteMetabolism and nutrition disorders | 10/136 | 3/38 |
| AnxietyPsychiatric disorders | 9/136 | 3/38 |
| DizzinessNervous system disorders | 10/136 | 2/38 |
The modified intent-to-treat (mITT) population included all participants who received at least one tablet of fexinidazole.
| Age, Continuous(years) | Inpatients | Outpatients | Total |
|---|---|---|---|
| Mean | 26.0 ± 15.5 | 27.9 ± 18.0 | 26.4 ± 16.0 |
| Sex: Female, Male(Participants) | Inpatients | Outpatients | Total |
|---|---|---|---|
| Female | 78 | 18 | 96 |
| Male | 58 | 20 | 78 |
| Race/Ethnicity, Customized(Participants) | Inpatients | Outpatients | Total |
|---|---|---|---|
| Sub-Saharan African | 136 | 38 | 174 |
| Region of Enrollment(Participants) | Inpatients | Outpatients | Total |
|---|---|---|---|
| Guinea | 26 | 6 | 32 |
| Congo, The Democratic Republic of the | 110 | 32 | 142 |
| g-HAT stage: Stage 1/intermediate, Stage 2(Participants) | Inpatients | Outpatients | Total |
|---|---|---|---|
| Stage 1/intermediate | 53 | 17 | 70 |
| Stage 2 | 83 | 21 | 104 |
| White blood cell (WBC) in cerebrospinal fluid (CSF)(Participants) | Inpatients | Outpatients | Total |
|---|---|---|---|
| 100 cells/µL or lower | 80 | 20 | 100 |
| Higher than 100 cells/µL | 56 | 18 | 74 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Nov 2016 to primary completion in Feb 2021, 50 months.
Results were first posted in Jun 2024, 3 years 4 months after primary completion.
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Studies of the drug tested here: Fexinidazole
Drugs for Neglected Diseases