At a glance
ClinicalIndex Comparison Record- ✓Confirmed trypanosome detection in any body fluid
- ✓Age ≥6 years
- ✓Body weight ≥20 kg
- ✓Karnofsky Performance Status >40%
- ✕Active clinically relevant medical conditions other than HAT that could jeopardize safety or interfere with study participation, including significant liver or cardiovascular disease, HIV infection, CNS trauma, seizure disorders, coma, or altered consciousness not related to HAT
- ✕Creatinine >3 times upper limit of normal (ULN)
- ✕ALT, AST, or bilirubin >3 times upper limit of normal (ULN)
- ✕Severely deteriorated general condition such as cardiovascular shock, respiratory distress, or terminal illness
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Fexinidazole for Trypanosomiasis, African and 2 related conditions. Completed, enrolled 174 participants across 8 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
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)