NCT03974178

Fexinidazole in Human African Trypanosomiasis Due to T. b. Rhodesiense

Efficacy and Safety of Fexinidazole in Patients With Human African Trypanosomiasis (HAT) Due to Trypanosoma Brucei Rhodesiense: a Multicentre, Open-label Clinical Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Drugs for Neglected Diseases · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

The ultimate goal of this study is to show that fexinidazole offers an alternative over the existing treatments of Human African trypanosomiasis due to Trypanosoma brucei rhodesiense (r-HAT): melarsoprol in patients with stage 2 r-HAT and suramin in patients with stage 1 r-HAT. The main questions it aims to answer are: * Is the short-term fatality rate and failure rate associated with fexinidazole lower than those of melarsoprol in patients with stage 2 r-HAT? * Is the long-term failure rate associated with fexinidazole lower than that of melarsoprol in patients with stage 2 r-HAT? * Can fexinidazole in patients with stage 1 r-HAT replace the treatment with suramin? * Is fexinidazole treatment safe in patient with r-HAT, regardless of stage? Participants will receive fexinidazole oral treatment for 10 days. Regular blood draws and lumbar punctures will be performed over 12 months to confirm the cure of the disease. Other assessments will include the recording of adverse events, signs and symptoms of the disease, laboratory tests, vital signs, electrocardiograms.

Conditions

• Trypanosomiasis, African
• Sleeping Sickness
• Trypanosoma Brucei Rhodesiense; Infection

Interventions

Type	Name	Description
DRUG	Fexinidazole	Tablets of 600 mg; Participants with a weight between 20 and 34 kg received 1200 mg (2 tablets) for 4 days, then 600 mg (1 tablet) for 6 days (with food); Participants with a weight of 35 kg and above received 1800 mg (3 tablets) for 4 days, then 1200 mg (2 tablets) for 6 days (with food)

Timeline

• Start date: 2019-09-29
• Primary completion: 2021-11-30
• Completion: 2022-10-12
• First posted: 2019-06-04
• Last updated: 2025-01-30
• Results posted: 2025-01-30

Locations

2 sites across 2 countries: Malawi, Uganda