Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02169557
Study type Interventional
Source Drugs for Neglected Diseases
Contact
Status Completed
Phase Phase 2/Phase 3
Start date April 30, 2014
Completion date April 25, 2017

See also
  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