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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-19

Study Completion Date

2028-03-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Chagas Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Historical control-based comparison, single-arm assignment, multicentre study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Benznidazole

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

Group Type EXPERIMENTAL

Benznidazole

Intervention Type DRUG

Drug: Benznidazole Tablets 100 mg (functionally scored) or Tablets 12.5 mg

Interventions

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Benznidazole

Drug: Benznidazole Tablets 100 mg (functionally scored) or Tablets 12.5 mg

Intervention Type DRUG

Other Intervention Names

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National Drug Code (NDC) 0642-7464-10 National Drug Code (NDC) 0642-7464-12

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No