CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 208 enrolled
Drug / intervention
Acoziboroledrug
Likely dose
Acoziborole 320 mgfrom 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.

Search/NCT03087955
NCT03087955Phase 3Completed
CompareCT.gov

Efficacy and Safety Study of Acoziborole (SCYX-7158) in Patients With Human African Trypanosomiasis (HAT) Due to Trypanosoma Brucei Gambiense: a Multicentre, Open-label, Prospective Study

Drugs for Neglected Diseases·interventional·Posted Mar 23, 2017·Updated Sep 17, 2025

In Brief

A Phase 3 clinical trial evaluating Acoziborole for Trypanosomiasis, African and 2 related conditions. Completed, enrolled 208 participants across 12 sites in 2 countries.

Detailed Summary

The goal of this study is to assess efficacy and safety of acoziborole in adult participants with Trypanosoma brucei gambiense (T.b. gambiense) HAT, either early- or intermediate-stage HAT (first arm) or late-stage HAT (second arm). Participants will receive 3 tablets of 320 mg as a single oral dose of acoziborole in the fasting state on Day 1. Participants will stay in the hospital for observation for 15 days. In total, participants will be followed for 18 months.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTrypanosomiasis, African, Gambiense Trypanosomiasis, Sleeping Sickness
CountriesDemocratic Republic of the Congo, Guinea
CollaboratorsBill and Melinda Gates Foundation

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 23, 2017
Enrollment StartOct 11, 2016
Primary CompletionSep 8, 2020
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 9.3 years ago

Interventions

Acoziboroledrug

Acoziborole 3 x 320 mg tablets (fasted state)