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

NCT05433350 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

  • Trypanosomiasis, African
  • Trypanosoma Brucei Gambiense; Infection
  • Sleeping 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

Sponsors & Collaborators

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Victor Kande Betu Ku Mesu, Dr · Ministry of Public Health, Hygiene and Prevention, Kinshasa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-09
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Democratic Republic of the Congo
  • Guinea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05433350 on ClinicalTrials.gov