Pharmacokinetic, Efficacy, Safety and Tolerability Study of a Single Dose of Acoziborole in g-HAT… (NCT05433350) | Clinical Trial Compass
CompletedPhase 2/3
Pharmacokinetic, Efficacy, Safety and Tolerability Study of a Single Dose of Acoziborole in g-HAT Paediatric Patients
Democratic Republic of the Congo, Guinea35 participantsStarted 2022-07-09
Plain-language 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.
Who can participate
Age range
1 Year – 14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) without consulting the investigator
* Agreement not to start a treatment (including traditional/herbal medicine) during 4 months after intake of acoziborole without consulting the Investigator
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
* Clinical…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum concentration (Cmax)
Timeframe: From time 0 to 96 hours
2
Area under the curve (AUC0-96h)
Timeframe: From time 0 to 96 hours
3
Time to maximum concentration (Tmax)
Timeframe: From time 0 to 96 hours
4
Area under curve (AUC0-∞)
Timeframe: Day 1 Hour 0, Day 1 Hour 4, Day 1 Hour 9, Day 2 Hour 24, Day 3 Hour 48, Day 4 Hour 72, Day 5 Hour 96, Day 11 Hour 264, month 3 any time
5
Clearance
Timeframe: Day 1 Hour 0, Day 1 Hour 4, Day 1 Hour 9, Day 2 Hour 24, Day 3 Hour 48, Day 4 Hour 72, Day 5 Hour 96, Day 11 Hour 264, month 3 any time
6
Volume of distribution (Vd)
Timeframe: Day 1 Hour 0, Day 1 Hour 4, Day 1 Hour 9, Day 2 Hour 24, Day 3 Hour 48, Day 4 Hour 72, Day 5 Hour 96, Day 11 Hour 264, month 3 any time
7
Half-life (t1/2)
Timeframe: Day 1 Hour 0, Day 1 Hour 4, Day 1 Hour 9, Day 2 Hour 24, Day 3 Hour 48, Day 4 Hour 72, Day 5 Hour 96, Day 11 Hour 264, month 3 any time