Effectiveness and safety of fexinidazole for gambiense human African trypanosomiasis and exploration of adherence in outpatients: a phase 3b, prospective, open-label, non-randomised, cohort study.

ABSTRACT:

Background

In previous clinical trials, oral fexinidazole treatment showed a favourable safety profile, while being easily administered and effective for most adult and paediatric patients with gambiense human African trypanosomiasis. The aim of this open-label cohort study was to investigate the effectiveness and safety of fexinidazole in a wider population of patients and to explore the feasibility of treating patients with gambiense human African trypanosomiasis outside the hospital setting.

Methods

In this phase 3b, prospective, open-label, non-randomised, cohort study, fexinidazole was administered orally as 600 mg tablets, in a dose regimen dependent on bodyweight. The study was conducted at eight treatment centres in the Democratic Republic of the Congo (seven of whic

SUBMITTER: Kumeso VKB 

PROVIDER: S-EPMC12041186 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature