Trials / Active Not Recruiting
Active Not RecruitingNCT04024163
Prospective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas Disease
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 178 (actual)
- Sponsor
- Insud Pharma · Industry
- Sex
- All
- Age
- 2 Years – 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Benznidazole | Drug: Benznidazole Tablets 100 mg (functionally scored) or Tablets 12.5 mg |
Timeline
- Start date
- 2019-09-19
- Primary completion
- 2027-08-30
- Completion
- 2028-03-30
- First posted
- 2019-07-18
- Last updated
- 2023-08-14
Locations
9 sites across 3 countries: Argentina, Bolivia, Colombia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04024163. Inclusion in this directory is not an endorsement.