A Phase 3 interventional study of Benznidazole in Chagas Disease, sponsored by Insud Pharma. Active, not recruiting at 9 sites in 3 countries. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Insud Pharma · Phase 3, Interventional, and Treatment
This study evaluate the efficacy and safety of benznidazole in the treatment of chronic indeterminate Chagas disease in children. All subjects will receive benznidazole and results will be compared to historically to a placebo arm.
73 studies on the registry are indexed under Chagas Disease; 5 are open to participants now.
This study's enrollment of 178 is above the median of 87 across 49 interventional studies indexed under Chagas Disease.
Browse Chagas Disease studies →Insud Pharma is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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 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.
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.
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.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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 recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
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.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
Benznidazole 100 mg Tablets or Benznidazole 12.5 mg Tablets by mouth, every 12 hours for 60 days
Drug: Benznidazole
Drug: Benznidazole Tablets 100 mg (functionally scored) or Tablets 12.5 mg
Also known as: National Drug Code (NDC) 0642-7464-10, National Drug Code (NDC) 0642-7464-12
Serological Cure by Conventional ELISA
Percentage of patients with negative conventional ELISA results as a measure of serological cure at the end of the 72-month follow up
Time frame: 72-month follow up
Serological Cure by Conventional ELISA at different timepoints
Percentage of patients with negative conventional ELISA results as a measure of serological cure
Time frame: Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up
Serological Cure by two conventional serology tests at 72 month
Percentage of patients with two negative conventional serology results as a measure of serological cure
Time frame: 72 months of follow-up
Serological Cure by two conventional serology tests at 48 months
Percentage of patients with two negative conventional serology results as a measure of serological cure
Time frame: 48 months of follow-up
Serological Cure by three serology tests at different timepoints
Percentage of patients with three negative serology results as a measure of serological cure
Time frame: Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up
Serological Cure by Non-Conventional ELISA at different timepoints
Percentage of patients with negative non-conventional ELISA (F29) results as a measure of serological cure
Time frame: Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up
Cure by qPCR at different timepoints
Consistently negative quantitative polymerase chain reaction (qPCR) results as a surrogate measure of cure
Time frame: Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up
Serological titres reduction at different timepoints
Reduction of conventional and nonconventional serological titres over the period of follow-up
Time frame: Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up
Progression of clinical disease at different timepoints
Percentage of patients with progression to clinical disease over the period of follow-up
Time frame: Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up
Progression of clinical disease and serological cure by one assay at different timepoints
Percentage of patients with no evidence of established cardiomyopathy over the period of follow-up and seroconversion to negative by one assay
Time frame: 48 and 72 months of follow-up
Progression of clinical disease and serological cure by two assays at different timepoints
Percentage of patients with no evidence of established cardiomyopathy over the period of follow-up and seroconversion to negative by two assay
Time frame: 48 and 72 months of follow-up
Safety and Tolerability
Rate and severity of adverse events (AEs)
Time frame: Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up
Population Pharmacokinetic - blood concentration
Benznidazole blood concentrations
Time frame: pre-dose, day 7 and day 30
Population Pharmacokinetic - area under the curve (AUC)
Benznidazole area under the curve (AUC)
Time frame: pre-dose, day 7 and day 30
Population Pharmacokinetic - volume of distribution
Benznidazole volume of distribution
Time frame: pre-dose, day 7 and day 30
Intensive Pharmacokinetic - blood concentrations
Benznidazole blood concentrations
Time frame: Day 1 or day 7
Intensive Pharmacokinetic - area under the curve (AUC)
Benznidazole area under the curve (AUC)
Time frame: Day 1 or day 7
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2019 (actual). Primary completion is estimated for Aug 2027, 95 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Benzonidazole
Insud Pharma