Status:
ACTIVE_NOT_RECRUITING
Pharmacokinetic, Efficacy, Safety and Tolerability Study of a Single Dose of Acoziborole in g-HAT Paediatric Patients
Lead Sponsor:
Drugs for Neglected Diseases
Conditions:
Trypanosomiasis, African
Trypanosoma Brucei Gambiense; Infection
Eligibility:
All Genders
1-14 years
Phase:
PHASE2
PHASE3
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 ...
Detailed Description
Human African trypanosomiasis (HAT), or sleeping sickness, is a life-threatening disease transmitted by tsetse flies and caused by a single-celled extracellular parasite that lives free in the bloodst...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT05433350
Start Date
July 9 2022
End Date
March 31 2026
Last Update
July 9 2025
Active Locations (6)
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1
General Hospital of Bandundu
Bandundu Province, Bandundu, Democratic Republic of the Congo
2
CDTC Katanda
Katanda, East Kasai, Democratic Republic of the Congo
3
Hôpital Général de Dipumba
Mbuji-Mayi, East Kasai, Democratic Republic of the Congo
4
HGR Bagata
Bagata, Kwilu, Democratic Republic of the Congo