Trypanosomiase humaine africaine
FEX007
Trypanosoma brucei (tb) rhodesiense Human African Trypanosomiasis(r-HAT) is rapidly lethal if untreated and has caused large epidemics in the past century and has a long history of MSF involvment. Today, approximately 1.5 million people live in areas still with moderate to high risk of contracting r-HAT, and latest WHO data (2012-2017) show that Uganda and Malawi reported the highest number of cases worldwide. To date, only one drug, melarsoprol, is available for late-stage (meningoencephalitic stage) r-HAT. The use of this arsenic-based drug is associated with severe adverse drug reactions, patients treated with melarsoprol need to be hospitalized, and melarsoprol-monotherapy could be prone to the development of parasite resistance to the drug in the long term. In a declaration for the elimination of HAT due to T.b. rhodesiense, WHO stakeholders urged for a safe, effective and preferably oral treatment.
Fexinidazole was identified by DNDi as a promising anti-protozoal drug candidate for the treatment of sleeping sickness. The ultimate goal of this study, "Efficacy and safety of fexinidazole in patients with Human African Trypanosomiasis (HAT) due to Trypanosoma brucei rhodesiense: a multicentre, open-label clinical trial" is to provide evidence for the safety and efficacy of fexinidazole for Tb rhodesiense HAT.
Objective
To show that fexinidazole offers an alternative over melarsoprol in stage-2 r-HAT patients
Methodology
Multicentre, open-label, non randomized, clinical trial of patients with r-HAT on efficacy/tolerability of fexinidazole. This trial was designed as a single arm trial treating patients with fexinidazole only.
Who's Involved Besides MSF?
DNDi, EDCTP, COVAB, MOH Uganda, MOH Malawi
Country
Malawi, Uganda
Tentative End date
December 2023
Our Role
Data Management & Statistics