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

• Register: ClinicalTrials.gov
• Last refreshed on: 31 October 2022
• Main ID: NCT03974178
• Date of registration: 23/05/2019
• Prospective Registration: Yes
• Primary sponsor: Drugs for Neglected Diseases
• Public title: Efficacy and Safety of Fexinidazole in Patients With Human African Trypanosomiasis (HAT) Due to Trypanosoma Brucei Rhodesiense
• Scientific title: Efficacy and Safety of Fexinidazole in Patients With Human African Trypanosomiasis (HAT) Due to Trypanosoma Brucei Rhodesiense: a Multicentre, Open-label Clinical Trial
• Date of first enrolment: September 29, 2019
• Target sample size: 45
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03974178
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2/Phase 3

Countries of recruitment

Malawi, Uganda

Contacts

• Name: Enock Matovu, Prof
• Affiliation: Makerere University

Key inclusion & exclusion 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)



Age minimum: 6 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Trypanosoma Brucei Rhodesiense; Infection

Intervention(s)

Drug: Fexinidazole

Primary Outcome(s)

Possibly Related fatality rate at the end of hospitalisation in stage 2 r-HAT patients [Time Frame: 12 to 18 days after start of treatment]

Secondary Outcome(s)

Success and failure outcomes at the test of cure [Time Frame: 12 months after start of treatment]

Unsatisfactory clinical and parasitological response [Time Frame: 11 days after start of treatment]

Occurrence of adverse events and serious adverse events [Time Frame: 12 months after start of treatment]

Success rate at the End of Treatment in all stages patients [Time Frame: 11 days after start of treatment]

Secondary ID(s)

DNDi-FEX-07-HAT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

European and Developing Countries Clinical Trials Partnership (EDCTP)