Chagas DiseasePhase 3NCT04024163
Prospective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas Disease
A Phase 3 study testing Benznidazole in people with Chagas Disease, run by Insud Pharma at 9 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Chagas Disease
- What is being tested?
- Benznidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 19 Sep 2019to 30 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 2 years and 18 years (age limits inclusive)
- Diagnosis of Trypanosoma cruzi (T. cruzi) infection by conventional serology based on positive ELISA and at least 1 other positive conventional serology test (recombinant ELISA or IIF)
- Written informed consent by parent/legal representative and informed assent from patients if >7 years old when applicable (as requirements may vary by country and by site)
- Females of childbearing potential (ie, female patients who have experienced menarche) and male patients must agree to use highly effective contraception if sexually active from the time of signing of the informed consent/assent form until ≥5 days after the last dose of study treatment
Who cannot join
- Pregnant or intending to become pregnant during treatment and within 5 days after the last dose of study treatment
- Patient presenting any other acute or chronic health conditions, which in the opinion of the Principal Investigator (PI), may interfere with the pharmacokinetic (PK), efficacy, and/or safety evaluation of the study treatment
- Signs and/or symptoms of acute Chagas Disease
- Known history of hypersensitivity or serious adverse reactions to nitroimidazoles
- History of Chagas Disease treatment with Benznidazole (BZN) or nifurtimox
- Immunocompromised (clinical history compatible with human immunodeficiency virus (HIV) infection, primary immunodeficiency, or prolonged treatment with corticosteroids or other immunosuppressive drugs)
Show all 14Show fewer
- Abnormal laboratory test values (as per protocol-specified ranges) at Screening for the following parameters: total white blood cell (WBC) count, platelet count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, and creatinine
- Abnormal ECG (as per protocol-specified ranges) and/or any Chagas disease associated findings
- Any condition that prevents the patient from taking oral medication
- Patient is known to or suspected of not being able to comply with the study protocol and the use of the investigational medicinal product (IMP)
- Evidence or history of alcohol or drug abuse (within the last 12 months)
- Any planned procedure that may interfere with highly effective contraception during treatment and within 5 days after the last dose of study treatment
- Employee of the Investigator or trial centre, or family member of the employees or the Investigator
- Any condition that, in the opinion of the Investigator, may jeopardise the trial conduct according to the protocol
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Argentina5 sites
Hospital de Ninos "Dr. Ricardo Gutierrez"
Buenos Aires
Hospital "Luis Carlos Lagomaggiore"
Mendoza
Hospital Pediatrico "Dr. Humberto Notti"
Mendoza
Hospital Público Descentralizado Dr. Guillermo Rawson
San Juan
Centro de Enfermedad de Chagas y Patologías Regionales
Santiago del Estero
Bolivia2 sites
Antigua Hospital Viedma
Cochabamba
CEADES - Plataforma de Chagas Sucre
Sucre
Colombia2 sites
Fundación Salud para el Trópico
Santa Marta
Centro de Atención e Investigación Médica (CAIMED)
Yopal
About this study
Official title: Prospective, Single-arm, Multicentre Study, Using a Historical Control, to Evaluate the Efficacy/Safety and Population Pharmacokinetics of Benznidazole in Children With Chronic Indeterminate Chagas Disease
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.
- Conditions
- Chagas Disease
- Being tested
- Benznidazole
- Medical subject headings
- Chagas Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenznidazoleDrug
Also called National Drug Code (NDC) 0642-7464-10, National Drug Code (NDC) 0642-7464-12
Drug: Benznidazole Tablets 100 mg (functionally scored) or Tablets 12.5 mg
| Study group | Role | What they receive |
|---|---|---|
| Benznidazole | Experimental | Benznidazole 100 mg Tablets or Benznidazole 12.5 mg Tablets by mouth, every 12 hours for 60 days Receives: Drug: Benznidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72-month follow up
Secondary outcomes (10)
Serological Cure by Conventional ELISA at different timepoints
Percentage of patients with negative conventional ELISA results as a measure of serological cure
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 48 and 72 months of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start19 Sep 2019
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chagas DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Historical control-based comparison, single-arm assignment, multicentre study
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insud Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chemo Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024163
- Sponsor's protocol ID
- LPRI747-301
- Status last verified
- Apr 2026
- First submitted
- 14 Jul 2019
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-arm, Multicentre Study, Using a Historical Control, to Evaluate the Efficacy/Safety and Population Pharmacokinetics of Benznidazole in Children With Chronic Indeterminate Chagas Disease
- ClinicalTrials.gov ID
- NCT04024163
- Acronym / sponsor ID
- LPRI747-301
- Conditions
- Chagas Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Insud PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Chemo Research
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Historical control-based comparison, single-arm assignment, multicentre study
| Arm | Type | Receives |
|---|---|---|
| Benznidazole | Experimental | Drug: BenznidazoleBenznidazole 100 mg Tablets or Benznidazole 12.5 mg Tablets by mouth, every 12 hours for 60 days |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age between 2 years and 18 years (age limits inclusive)
- Diagnosis of Trypanosoma cruzi (T. cruzi) infection by conventional serology based on positive ELISA and at least 1 other positive conventional serology test (recombinant ELISA or IIF)
- Written informed consent by parent/legal representative and informed assent from patients if >7 years old when applicable (as requirements may vary by country and by site)
- Females of childbearing potential (ie, female patients who have experienced menarche) and male patients must agree to use highly effective contraception if sexually active from the time of signing of the informed consent/assent form until ≥5 days after the last dose of study treatment
Key exclusion criteria (14 listed)
- Pregnant or intending to become pregnant during treatment and within 5 days after the last dose of study treatment
- Patient presenting any other acute or chronic health conditions, which in the opinion of the Principal Investigator (PI), may interfere with the pharmacokinetic (PK), efficacy, and/or safety evaluation of the study treatment
- Signs and/or symptoms of acute Chagas Disease
- Known history of hypersensitivity or serious adverse reactions to nitroimidazoles
- History of Chagas Disease treatment with Benznidazole (BZN) or nifurtimox
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BenznidazoleAlso: National Drug Code (NDC) 0642-7464-10, National Drug Code (NDC) 0642-7464-12Drug: Benznidazole Tablets 100 mg (functionally scored) or Tablets 12.5 mg | Drug | Benznidazole |
Primary outcome
Serological Cure by Conventional ELISA
Time frame: 72-month follow up
Percentage of patients with negative conventional ELISA results as a measure of serological cure at the end of the 72-month follow up
10 secondary outcomes
Serological Cure by Conventional ELISA at different timepoints
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
Time frame: 72 months of follow-up
Serological Cure by two conventional serology tests at 48 months
Time frame: 48 months of follow-up
Serological Cure by three serology tests at different timepoints
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
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
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
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
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
Time frame: 48 and 72 months of follow-up
Progression of clinical disease and serological cure by two assays at different timepoints
Time frame: 48 and 72 months of follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Benznidazole in people with Chagas Disease, run by Insud Pharma at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Argentina, Bolivia, Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serological Cure by Conventional ELISA (time frame: 72-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.