CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 450 enrolled
Drug / intervention
Benznidazole +1 moredrug
Likely dose
Benznidazole 50 mgfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03981523
NCT03981523Phase 2Completed

New Chemotherapy Regimens and Biomarkers for Chagas Disease

University of Texas, El Paso·interventional·Posted Jun 11, 2019·Updated Jul 17, 2024

In Brief

A Phase 2 clinical trial evaluating Benznidazole and Nifurtimox for Trypanosoma Cruzi Infection and Chagas Disease. Completed, enrolled 450 participants across 3 sites.

Detailed Summary

Chagas disease (CD) is an endemic zoonotic disease with a significant global impact. Current approved treatments for CD (benznidazole (BZN) and nifurtimox (NFX)) were developed in the 1970s with regimens and dosing intervals derived from decades-old patient series and with very limited direct comparisons. Treatment recommendations vary significantly from country to country and the comparative evidence-base with the current treatment regimens is limited. The reported efficacy of both drugs in patients with T. cruzi infection is variable and depends on the disease stage, the drug dose, the age of patients, and the infecting T. cruzi strain or genotype. Due to a therapeutic failure of at least 20% after 12 months in chronic patients and the high rate of adverse events, together with the recent data that suggest that we may be overdosing patients, we propose to test new dosing regimens of these two old compounds. Hypotheses: * Lowering the frequency of drug dosing of BZN and NFX, the plasma drug levels of the drugs within the therapeutic range will be maintained. * The duration of treatment with BZN or NFX may be related to the effectiveness of these drugs. * Blood levels of the proposed biomarkers will significantly diminish or became negative after a relatively short interval after treatment.

Study Details

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJun 11, 2019
Enrollment StartDec 18, 2019
Primary CompletionMay 29, 2024
Study CompletionMay 31, 2024
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 7.1 years ago

Interventions

Benznidazoledrug

50 mg and 100 mg tablet taken orally

Nifurtimoxdrug

120 mg tablet taken orally