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

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ClinicalTrials.gov Identifier: NCT04024163
Recruitment Status : Not yet recruiting
First Posted : July 18, 2019
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
Chemo Research S.L.
Information provided by (Responsible Party):
Insud Pharma

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.

Condition or disease Intervention/treatment Phase
Chagas Disease Drug: Benznidazole Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Historical control-based comparison, single-arm assignment, multicentre study
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : August 30, 2019
Estimated Primary Completion Date : August 30, 2026
Estimated Study Completion Date : March 2, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chagas Disease

Arm Intervention/treatment
Experimental: Benznidazole
Benznidazole 100 mg Tablets or Benznidazole 12.5 mg Tablets by mouth, every 12 hours for 60 days
Drug: Benznidazole
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 Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04024163


Contacts
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Contact: Enrico Colli, MD 0034-913-021-560 enrico.colli@exeltis.com

Sponsors and Collaborators
Insud Pharma
Chemo Research S.L.

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Responsible Party: Insud Pharma
ClinicalTrials.gov Identifier: NCT04024163     History of Changes
Other Study ID Numbers: LPRI747-301
First Posted: July 18, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Chagas Disease
Parasitic Diseases
Trypanosomiasis
Euglenozoa Infections
Protozoan Infections
Benzonidazole
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents