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
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|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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|