Pharmacokinetic, Efficacy, Safety and Tolerability Study of a Single Dose of Acoziborole in g-HAT Paediatric Patients
Trial Parameters
Brief Summary
Acoziborole has been studied in an open-label pivotal Phase II/III trial (DNDi-OXA-02-HAT) in the DRC and Guinea. As the numbers of reported cases diminish, resources for surveillance and specialised screening will also taper. This decrease, coupled with the loss of diagnostic skills and disease management expertise, will lead to a weak and less specialised HAT technical environment. The history of g-HAT has shown that outbreaks or re-emergence of the disease have already happened under different circumstances when surveillance was relaxed or simply because the populations at risk live in areas of political instability, limiting access to specialised care. Even with a steady decrease of reported incidence, no model can currently predict that HAT could not re-emerge. Although g-HAT is predominantly a disease of adults, children are also affected at diverse rates depending on the geographical and behavioural characteristics in the different areas of disease transmission. Hence efforts are needed to develop a paediatric formulation from a new generation of oral HAT treatments.
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 avoid getting pregnant during the screening period and up to 3 months after acoziborole dosing by using an acceptable effective contraception method (sexual abstinence, condom, injectable progestin-only contraceptive) * Agreement not to continue any treatment (including traditional/herbal medicine) witho