Prospective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas Disease

NCT04024163 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: LPRI747-301
• Study Type: interventional
• Target: 178
• Locations: 3 countries
• Sites: 9

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

  72-month follow up

Secondary Outcomes (10)

• Serological Cure by Conventional ELISA at different timepoints

  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

  72 months of follow-up

• Serological Cure by two conventional serology tests at 48 months

  48 months of follow-up

• Serological Cure by three serology tests at different timepoints

  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

  Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up

Other Outcomes (6)

• Safety and Tolerability

  Day 60 (EOT), and 4, 6, 12, 24, 36, 48, 60, and 72 months of follow-up

• Population Pharmacokinetic - blood concentration

  pre-dose, day 7 and day 30

• Population Pharmacokinetic - area under the curve (AUC)

  pre-dose, day 7 and day 30

Study Arms (1)

Benznidazole

EXPERIMENTAL

Benznidazole 100 mg Tablets or Benznidazole 12.5 mg Tablets by mouth, every 12 hours for 60 days

Drug: Benznidazole

Interventions

Benznidazole DRUG

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

Benznidazole

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Insud Pharma: lead
• Chemo Research: collaborator

Study Sites (9)

Hospital de Ninos "Dr. Ricardo Gutierrez"

Buenos Aires, Argentina

Location

Hospital "Luis Carlos Lagomaggiore"

Mendoza, Argentina

Location

Hospital Pediatrico "Dr. Humberto Notti"

Mendoza, Argentina

Location

Hospital Público Descentralizado Dr. Guillermo Rawson

San Juan, Argentina

Location

Centro de Enfermedad de Chagas y Patologías Regionales

Santiago del Estero, Argentina

Location

Antigua Hospital Viedma

Cochabamba, Bolivia

Location

CEADES - Plataforma de Chagas Sucre

Sucre, Bolivia

Location

Fundación Salud para el Trópico

Santa Marta, Colombia

Location

Centro de Atención e Investigación Médica (CAIMED)

Yopal, Colombia

Location

MeSH Terms

Conditions

Chagas Disease

Interventions

benzonidazole

Condition Hierarchy (Ancestors)

Trypanosomiasis; Euglenozoa Infections; Protozoan Infections; Parasitic Diseases; Infections; Vector Borne Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Historical control-based comparison, single-arm assignment, multicentre study

Study Record Dates

• First Submitted: July 14, 2019
• First Posted: July 18, 2019
• Study Start: September 19, 2019
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): March 30, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AR (5); BO (2); CO (2)