Efficacy and Safety of Fexinidazole in Patients With Human African Trypanosomiasis (HAT) Due to Trypanosoma Brucei Rhodesiense
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|ClinicalTrials.gov Identifier: NCT03974178|
Recruitment Status : Not yet recruiting
First Posted : June 4, 2019
Last Update Posted : August 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Trypanosoma Brucei Rhodesiense; Infection||Drug: Fexinidazole||Phase 2 Phase 3|
Nowadays, the only treatment available for the stage 2 of HAT due to t.b rhodesiense is melarsoprol, a very toxic drug.
The primary objective of this trial is to evaluate fexinidazole as an alternative treatment over melarsoprol in patients with stage 2 of HAT disease due to t.b rhodesiense in a Phase II/III cohort trial with 34 stage 2 patients. All stages of the disease will be recruited but the recruitment will stop once 34 stage 2 patients have reached the end of treatment.
The trial will be a multicentre, non-randomized, clinical trial in patients with r-HAT.
Subjects will be recruited among the patients reporting to Lwala Hospital (Uganda) and Rumphi District Hospital (Malawi). If feasible, r-HAT patients from other hospitals and centres in Kaberamaido/Dokolo Districts (Uganda) and Rumphi/Mzimba North District (Malawi) and well as Zambia bordering areas, will be referred to Lwala and Rumphi Hospitals, respectively, for treatment.
Fexinidazole is an oral treatment which has to be taken every day for 10 days. In case of lack of efficacy (e.g. disease relapse) the patients will be switched to the standart treatment that is part of the National Control Program in each country (melarsoprol for stage-2 patients and suramin for stage-1 patients)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Safety of Fexinidazole in Patients With Human African Trypanosomiasis (HAT) Due to Trypanosoma Brucei Rhodesiense: a Multicentre, Open-label Clinical Trial|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||June 2022|
|Estimated Study Completion Date :||March 2023|
All adults and children with a body weight ≥ 35 kg:
Children with a body weight ≥ 20 and < 35 kg:
Adults and Children patients will receive fexinidazole tablets every day for 10 days
- Possibly Related fatality rate at the end of hospitalisation in stage 2 r-HAT patients [ Time Frame: 12 to 18 days after start of treatment ]Death possibly related to r-HAT or treatment according to DSMB; since at the study sites anatomopathological techniques are not available, the completion of the WHO verbal autopsy questionnaire will be requested in case of death)
- Success rate at the End of Treatment in all stages patients [ Time Frame: 11 days after start of treatment ]success is defined as: patient alive and no trypanosomes at end of hospitalization. Failure is defined as: death or presence of trypanosomes in any body fluid at end of hospitalization. Deaths to be considered are defined as possibly related to r-HAT or treatment according to DSMB. Unrelated deaths are neither success nor failure
- Success and failure outcomes at the test of cure [ Time Frame: 12 months after start of treatment ]A modification of the WHO recommendations is used to determine success and failure for stage-1 and stage-2 r-HAT patients (Appendix I - Evaluation criteria of efficacy endpoints)
- Occurrence of adverse events and serious adverse events [ Time Frame: 12 months after start of treatment ]3. Occurrence of adverse events, including abnormal laboratory or ECG findings, during the observation period (until the end of hospitalisation scheduled up to 7 days after EOT) and those considered as possibly related to r-HAT or treatment, among those detected until the end of the follow-up period (12-month visit). All serious adverse events (SAE) whether they are considered as possibly related to r-HAT treatment or not.
- Unsatisfactory clinical and parasitological response [ Time Frame: 11 days after start of treatment ]defined as the compound analysis of the clinical evolution (symptoms of HAT) associated with presence of parasites in at least one body fluid (via blood test and/or lumbar puncture)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974178
|Contact: Christelle Perdrieuemail@example.com|
|Contact: Olaf Valverde, Drfirstname.lastname@example.org|
|Principal Investigator:||Enock Matovu, Prof||Makerere University|