NCT03025789

Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage

An Open-label Study Assessing Effectiveness, Safety and Compliance With Fexinidazole in Patients With Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Drugs for Neglected Diseases · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the effectiveness of fexinidazole administered to patients with human African trypanosomiasis due to T. b. gambiense (g-HAT) at all stages of the disease. The aim of the present study is to provide additional information on the effectiveness and safety of fexinidazole and to assess its use under conditions as close as possible to those in real life, both in patients treated on an out-patient basis and in the hospital setting, depending on clinical status. Participants will receive fexinidazole oral treatment for 10 days. Regular blood draws and lumbar punctures will be performed over 18 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. Treatment compliance, feasibility, and packaging acceptability will be thoroughly assessed in the participants receiving treatment at home. Those participants will complete questionnaires to check that instructions for fexinidazole administration are clear enough and followed correctly.

Detailed description

See attached protocol.

Conditions

• Trypanosomiasis, African
• Sleeping Sickness
• Trypanosomiasis; Gambian

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: 2016-11-10
• Primary completion: 2021-02-01
• Completion: 2021-02-01
• First posted: 2017-01-20
• Last updated: 2025-01-08
• Results posted: 2024-06-07

Locations

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