Human African Trypanosomiasis (HAT) Clinical Trial
Official title:
Efficacy and Safety of Fexinidazole in Patients With Stage 1 or Early Stage 2 Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open-label Cohort Study, plug-in to the Pivotal Study
The purpose of this study is to demonstrate the treatment success of fexinidazole, at one year follow-up visit, in HAT stage 1 and early stage 2 patients.
Primary Objective
-To demonstrate that the success rate of fexinidazole at one year follow-up in stage 1 and
early stage 2 patients is greater than 80%. An 80 % success rate is considered as
unacceptable.
Secondary Objectives
- To verify whether the success rate of fexinidazole treatment depends on the stage of the
disease (stage 1 versus early stage 2); and, if the difference between the 2 stages is
significant, to show that the success rate is greater than 80% and compatible with the
historical success rate of NECT in early stage 2 patients and with the historical
success rate of pentamidine in stage 1 patients.
- To verify whether the success rate of fexinidazole treatment depends on the number of
WBCs in CSF before treatment initiation.
- To assess changes in the success rate over time.
- To evaluate the safety of fexinidazole and determine whether its safety profile is
comparable to the historical safety profile of pentamidine.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01685827 -
Pivotal Study of Fexinidazole for Human African Trypanosomiasis in Stage 2
|
Phase 2/Phase 3 | |
| Completed |
NCT02184689 -
Efficacy and Safety of Fexinidazole in Children at Least 6 Years Old and Weighing Over 20 kg With Human African Trypanosomiasis (HAT) Due to T.b. Gambiense: a Prospective, Multicentre, Open Study, plug-in to the Pivotal Study
|
Phase 2/Phase 3 |