Prospective Study on Efficacy and Safety of Acoziborole (SCYX-7158) in Patients Infected by Human African Trypanosomiasis Due to T.b. Gambiense

• Status: Active, not recruiting
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to assess efficacy and safety of Acoziborole (SCYX-7158) given as a single dose oral treatment for adult patients (above or equal 15) in the fasting state with T.b. Gambiense HAT

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Drugs for Neglected Diseases

Criteria

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 potential, confirmed pregnancy on a urine pregnancy test performed within 24 hours prior to administration of SCYX-7158)

• Clinically significant medical condition that could, in the opinion of the Investigator, jeopardise the patient's safety or interfere with participation in the study, including, but not limited to significant liver or cardiovascular disease, suspected or proven active infection, central nervous system trauma or seizure disorder, coma or consciousness disturbances

• Severely deteriorated health status, e.g. due to cardiovascular shock, respiratory distress syndrome or end-stage disease

• Previously treated for HAT (except prior treatment with pentamidine)

• Prior enrolment in the study

• Foreseeable difficulty complying with follow-up, including migrant worker, refugee status, itinerant trader etc.

• Current alcohol abuse or drug addiction

• Not tested for malaria and/or not having received appropriate treatment for malaria

• Not having received appropriate treatment for soil-transmitted helminthiasis

• Clinically significant abnormal laboratory values including Aspartate AminoTransferase(AST) and/or AlanineAminoTransferase (ALT) more than 2 times the upper limit of normal (ULN), total bilirubin more than 1.5 ULN, severe leukopenia at less than 2000/mm3, Potassium below 3.5 mmol/L, any other clinically significant abnormal laboratory value