Pharmacokinetic, Efficacy, Safety and Tolerability Study of a Single Dose of Acoziborole in g-HAT Paediatric Patients

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

July 9, 2022

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
Trypanosomiasis, AfricanTrypanosoma Brucei Gambiense; InfectionSleeping Sickness
Interventions
DRUG

Acoziborole

"Two different mode of administration will be used during the study depending on the body weight and on the step of the study:~whole tablets of 320 mg dose for paediatric patients weighing 30 to 40 kg in step 1 whole or crushed tablets for paediatric patients weighing 10 to 40 kg in step 2"

Trial Locations (6)

Unknown

General Hospital of Bandundu, Bandundu Province

CDTC Katanda, Katanda

Hôpital Général de Dipumba, Mbuji-Mayi

HGR Bagata, Bagata

Hospital of Masi-Manimba, Masi-Manimba

General Referral Hospital of Dubreka, Dubréka

All Listed Sponsors
lead

Drugs for Neglected Diseases

OTHER