At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 45 enrolled
Drug / intervention
Fexinidazole +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2 Randomized, Multicenter, Double-blinded Safety and Efficacy Study to Evaluate Oral Fexinidazole Dosing Regimens for the Treatment of Adult Patients With Chronic Indeterminate Chagas Disease
In Brief
A Phase 2 clinical trial evaluating Fexinidazole and Placebo Oral Tablet for Chagas' Disease (Chronic) Nos. Completed, enrolled 45 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChagas' Disease (Chronic) Nos
CountriesSpain
Collaborators--
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartNov 2017
First PostedJul 2018
Primary CompletionDec 2018
Study CompletionAug 2019
TodayJul 2026
First PostedJul 16, 2018
Enrollment StartNov 13, 2017
Primary CompletionDec 19, 2018
Study CompletionAug 28, 2019
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 8.0 years ago
Interventions
Fexinidazoledrug
Drug: fexinidazole (FEXI)
Placebo Oral Tabletdrug
Drug: fexinidazole