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Oral Fexinidazole Dosing Regimens for the Treatment of Adults With Chronic Indeterminate Chagas Disease

NCT03587766 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-09-23

No results posted yet for this study

Summary

This study focuses on the evaluation of low doses (600 and 1200 mg) and short treatment duration (at 3, 7 and 10 days) of fexinidazole (Fexi) to determine the minimal efficacious and safe dose for the treatment of adult patients with chronic indeterminate Chagas Disease (CD).

Conditions

  • Chagas' Disease (Chronic) Nos

Interventions

DRUG

Fexinidazole

Drug: fexinidazole (FEXI)

DRUG

Placebo Oral Tablet

Drug: fexinidazole

Sponsors & Collaborators

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Joaquim Gascón, MD · Centro de Salud Internacional, Hospital Clínico de Barcelona ISGlobal - Barcelona Institute for Global Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-13
Primary Completion
2018-12-19
Completion
2019-08-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03587766 on ClinicalTrials.gov