Prospective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas Disease
NCT04024163 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 178
Last updated 2026-04-21
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.
Conditions
- Chagas Disease
Interventions
- DRUG
-
Benznidazole
Drug: Benznidazole Tablets 100 mg (functionally scored) or Tablets 12.5 mg
Sponsors & Collaborators
-
Chemo Research
collaborator INDUSTRY -
Insud Pharma
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 2 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-19
- Primary Completion
- 2027-08-30
- Completion
- 2028-03-30
- FDA Drug
- Yes
Countries
- Argentina
- Bolivia
- Colombia
Study Locations
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