Pharmacokinetic, Efficacy, Safety and Tolerability Study of a Single Dose of Acoziborole in g-HAT Paediatric Patients (OXA005)
Trypanosomiasis, African, Trypanosoma Brucei Gambiense; Infection, Sleeping Sickness
About this trial
This is an interventional treatment trial for Trypanosomiasis, African focused on measuring g-HAT, ACOZI-KIDS
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent from one parent or from the legal representative
- Assent from the paediatric patient (for paediatric patients >6 years of age) to participate in the study, collected in the presence of an impartial witness
- Between 1 and 14 years of age and between 10 and ≤40 kg (as per the requirements of step 1 and step 2)
- Male or female
- Evidence of trypanosomes in any body fluid (blood or lymph or CSF)
- Having a permanent address and able to comply with the schedule of follow-up visits
- Agreement to not take part in any other clinical trials during the participation in this study
- For pubescent girls of childbearing potential must agree to have protected sexual relations to avoid becoming pregnant from enrolment up to 3 months after dosing (contraceptive protection will be advised and offered at no cost)
Exclusion Criteria:
- Previous treatment for g-HAT
- Refusal to participate in the study, expressed by the paediatric patient and/or parent or legal representative
- Complicated severe acute malnutrition as defined by weight for height (-3 SDs Z score)
- Unable to take medication by the oral route
- Clinically significant medical condition (other than HAT) that could, in the opinion of the Investigator, jeopardise the patient's safety or interfere with participation in the study
- Any condition (excluding HAT-specific symptoms) that affects the patient's and/or parent's ability to communicate with the Investigator as required to complete the study
- Prior enrolment in the study or prior intake of acoziborole
- Foreseeable difficulty complying with follow-up, including family of migrant workers, refugee status, itinerant trader, etc.
Clinically significant laboratory test abnormality, with:
- Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) more than twice the upper limit of normal (ULN)
- Total bilirubin more than 1.5 x ULN
- Severe leukopenia at <2000/mm3
- Potassium <3.5 mmol/L
- Any other clinically significant laboratory test abnormality
- Pregnancy confirmed by a positive urine pregnancy test (during the screening period and/or within 24 hours prior to the start of treatment) for pubescent girls of childbearing potential
- Not tested for malaria and/or not having received appropriate treatment for malaria
- Not having received appropriate treatment for soil-transmitted helminthiasis
Sites / Locations
- Hôpital Général de DipumbaRecruiting
- CDTC KatandaRecruiting
- HGR BagataRecruiting
- Hospital of Masi-ManimbaRecruiting
- General Hospital of BandunduRecruiting
Arms of the Study
Arm 1
Experimental
Acoziborole
Single dose administration Two different formulations will be used depending on the body weight and on the step of the study: Tablets of 320 mg dose for paediatric patients weighing 30 to 40 kg in step 1. Granules in bottle for paediatric patients weighing 10 to 40 kg in step 2. Granules will be packed in bottles of 160 mg dose. Initially, recruitment will be limited to paediatric patients weighing 30 to 40 kg who will receive the 320 mg tablet formulation. Once the PK data from the first six patients have been analysed and the dosing regimen confirmed or adapted, inclusion will resume and be extended to allow enrolment of paediatric patients weighing >10 kg with the granule formulation (including for paediatric patients weighing 30 to 40 kg).