Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT05433350
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) 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
* 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
* Paediatric patient who is taking praziquantel, erythromycin, ritonavir, lopinavir, or darunavir and could not stop this treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
14 Years
Study:
NCT05433350
Study Brief:
Protocol Section:
NCT05433350