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
|ClinicalTrials.gov Identifier: NCT02169557|
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : June 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Human African Trypanosomiasis (HAT)||Drug: Fexinidazole||Phase 2 Phase 3|
-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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||230 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||April 30, 2014|
|Actual Primary Completion Date :||October 9, 2016|
|Actual Study Completion Date :||April 25, 2017|
- Outcome (success or failure) at the test of cure (ToC) visit 12 months after the end of treatment (EOT). [ Time Frame: 12 months after end of treatment (day 11) ]
- Success or failure at each visit between the End of treatment and 18 months visit. [ Time Frame: End of treatment (day 11) to last follow-up visit (18 months) ]
- Safety [ Time Frame: From signature of informed consent to 18 months Follow up visit ]
- Occurrence of any grade AEs (all grades combined) during the observation period.
- Occurrence of drug-related AEs (Grade ≥ 3 and any grade) during the observation period.
- Occurrence of any serious adverse events (SAE) from first drug intake to the end of follow up period (M18).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169557
|Congo, The Democratic Republic of the|
|Kinshasa, Congo, The Democratic Republic of the|