MedTrace Logo

Efficacy and Safety of Acoziborole (SCYX-7158) in Patients With Human African Trypanosomiasis Due to T.b. Gambiense

NCT03087955 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2025-09-17

Study results available
· View outcomes & findings →

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.

Conditions

  • Trypanosomiasis, African
  • Gambiense Trypanosomiasis
  • Sleeping Sickness

Interventions

DRUG

Acoziborole

Acoziborole 3 x 320 mg tablets (fasted state)

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Victor Kande Betu Kumeso, Dr · Ministère de la Santé, The Democratic Republic of the Congo

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-11
Primary Completion
2020-09-08
Completion
2020-09-08

Countries

  • Democratic Republic of the Congo
  • Guinea

Study Locations

More Related Trials

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 NCT03087955 on ClinicalTrials.gov