NCT02169557

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Drugs for Neglected Diseases · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Human African Trypanosomiasis (HAT)

Interventions

Type	Name	Description
DRUG	Fexinidazole

Timeline

• Start date: 2014-04-30
• Primary completion: 2016-10-09
• Completion: 2017-04-25
• First posted: 2014-06-23
• Last updated: 2020-06-24

Locations

1 site across 1 country: Democratic Republic of the Congo