Efficacy and Safety of Fexinidazole in Patients With Human African Trypanosomiasis (HAT) Due to Trypanosoma Brucei Rhodesiense

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims at evaluating the efficacy and safety of a new oral treatment drug against Human African trypanosomiasis (HAT) due to T.b rhodesiense. 34 patients will be recruited in 2 sites located in Malawi and Uganda. All patients will receive the study drug fexinidazole.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Drugs for Neglected Diseases
• Collaborator: European and Developing Countries Clinical Trials Partnership (EDCTP)

Criteria

Inclusion Criteria:

• Signed Informed Consent Form (plus assent for children)

• ≥ 6 years old

• ≥ 20 kg body weight

• Ability to ingest at least one complete meal per day (or at least one Plumpy'Nut® sachet)

• Karnofsky index ≥ 40

• Parasitological confirmed of T.b. rhodesiense infection

• Having a permanent address or being traceable by others and willing and able to comply with follow-up visit schedule

• Agreement to be hospitalised for a minimum of 13 days and to receive the study treatment

Exclusion Criteria:

• Active clinically relevant medical conditions other than HAT that may jeopardize subject safety or at the investigator discretion may interfere with participation in the study.

• Compromised general health or severely deteriorated general condition, such as severe malnutrition, cardiovascular shock, respiratory distress, or terminal illness

• Known hypersensitivity to fexinidazole, to any nitroimidazole drugs (e.g. metronidazole, tinidazole) or to any of the excipients

• Patients previously enrolled in the study or having already received fexinidazole

• Patients with severe hepatic impairment (ex: clinical signs of cirrhosis or jaundice)