Efficacy and Safety of Acoziborole (SCYX-7158) in Patients With Human African Trypanosomiasis Due… (NCT03087955) | Clinical Trial Compass
CompletedPhase 2/3
Efficacy and Safety of Acoziborole (SCYX-7158) in Patients With Human African Trypanosomiasis Due to T.b. Gambiense
Democratic Republic of the Congo208 participantsStarted 2016-10-11
Plain-language summary
The goal of this study is to assess efficacy and safety of acoziborole in adult participants with Trypanosoma brucei gambiense (T.b. gambiense) HAT, either early- or intermediate-stage HAT (first arm) or late-stage HAT (second arm). Participants will receive 3 tablets of 320 mg as a single oral dose of acoziborole in the fasting state on Day 1. Participants will stay in the hospital for observation for 15 days. In total, participants will be followed for 18 months.
Who can participate
Age range15 Years
SexALL
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Inclusion Criteria:
* Male or female patient
* 15 years of age or older
* Signed informed consent form (as well as assent from illiterate and under-age patients, and those unable to give consent)
* Karnofsky Performance Status above 50
* Able to ingest oral tablets
* Having a permanent address or being traceable by other persons
* Able to comply with the schedule of follow-up visits and requirements of the study
* Agreement to be hospitalised in order to receive treatment
* For patients with late-stage HAT:
* Confirmation of g-HAT by detection of the parasite in the blood and/or the lymph and/or the CSF, at the investigational centre
* If trypanosomes are found in the blood or lymph, but not in the CSF, the CSF WBC, measured at the investigational centre, must be above 20/μL for the patient to be included in the cohort of patients with late-stage HAT
* For patients with early- or intermediate-stage HAT:
* Confirmation of g-HAT by detection of the parasite in the blood and/or the lymph, at the investigational centre
* Absence of parasites in the CSF
* The CSF WBC, measured at the investigational centre, must be between 6 and 20/μL for the patient to be included in the cohort of patients with intermediate-stage HAT and equal to or below 5/μL for the patient to be included in the cohort of patients with early-stage HAT.
Exclusion Criteria:
* Severe malnourishment, defined as body-mass index (BMI) below 16
* Pregnancy or breastfeeding (for women of child-bearing po…
What they're measuring
1
Percentage of Participants With Late-stage HAT Whose Treatment Outcome Was a Success at Month 18 According to Adapted World Health Organization (WHO) Criteria