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Active, Not Recruiting

NCT Number: NCT04024163

Prospective Study of Benznidazole for Chagas' Disease 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Chagas Disease Euglenozoa Infections Infections Parasitic Diseases Protozoan Infections Trypanosomiasis Vector Borne Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital de Ninos "Dr. Ricardo Gutierrez", Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Benznidazole

Drug

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

Other names: National Drug Code (NDC) 0642-7464-10, National Drug Code (NDC) 0642-7464-12

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    Percentage of patients with negative conventional ELISA results as a measure of serological cure

  2. Serological Cure by two conventional serology tests at 72 month

    Time frame: 72 months of follow-up

    Percentage of patients with two negative conventional serology results as a measure of serological cure

  3. Serological Cure by two conventional serology tests at 48 months

    Time frame: 48 months of follow-up

    Percentage of patients with two negative conventional serology results as a measure of serological cure

  4. 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

    Percentage of patients with three negative serology results as a measure of serological cure

  5. 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

    Percentage of patients with negative non-conventional ELISA (F29) results as a measure of serological cure

  6. 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

    Consistently negative quantitative polymerase chain reaction (qPCR) results as a surrogate measure of cure

  7. 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

    Reduction of conventional and nonconventional serological titres over the period of follow-up

  8. 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

    Percentage of patients with progression to clinical disease over the period of follow-up

  9. Progression of clinical disease and serological cure by one assay at different timepoints

    Time frame: 48 and 72 months of follow-up

    Percentage of patients with no evidence of established cardiomyopathy over the period of follow-up and seroconversion to negative by one assay

  10. Progression of clinical disease and serological cure by two assays at different timepoints

    Time frame: 48 and 72 months of follow-up

    Percentage of patients with no evidence of established cardiomyopathy over the period of follow-up and seroconversion to negative by two assay

Other outcomes

  1. Safety and Tolerability

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

    Rate and severity of adverse events (AEs)

  2. Population Pharmacokinetic - blood concentration

    Time frame: pre-dose, day 7 and day 30

    Benznidazole blood concentrations

  3. Population Pharmacokinetic - area under the curve (AUC)

    Time frame: pre-dose, day 7 and day 30

    Benznidazole area under the curve (AUC)

  4. Population Pharmacokinetic - volume of distribution

    Time frame: pre-dose, day 7 and day 30

    Benznidazole volume of distribution

  5. Intensive Pharmacokinetic - blood concentrations

    Time frame: Day 1 or day 7

    Benznidazole blood concentrations

  6. Intensive Pharmacokinetic - area under the curve (AUC)

    Time frame: Day 1 or day 7

    Benznidazole area under the curve (AUC)

Sponsors and collaborators

Lead sponsor

Insud Pharma

Industry

Collaborators

  • Chemo Research

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Jul 18, 2019
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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