NCT03087955

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Drugs for Neglected Diseases · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Acoziborole	Acoziborole 3 x 320 mg tablets (fasted state)

Timeline

• Start date: 2016-10-11
• Primary completion: 2020-09-08
• Completion: 2020-09-08
• First posted: 2017-03-23
• Last updated: 2025-09-17
• Results posted: 2025-09-17

Locations

12 sites across 2 countries: Democratic Republic of the Congo, Guinea