Human African Trypanosomiasis (Sleeping Sickness)

Oxaboroles

Acoziborole (SCYX-7158) pivotal study in adults with stage 1 and stage 2 HAT  Phase II/III

NCT03087955 |  Democratic Republic of the Congo

A pivotal study assessing efficacy and safety of acoziborole (SCYX-7158) in patients with stage 1 and stage 2 human African trypanosomiasis due to T.b. Gambiense.

Acoziborole (SCYX-7158) Phase I

NCT01533961 |  France  |  Completed

Human African trypanosomiasis: first-in-man clinical trial of a new medicinal product, acoziborole (SCYX-7158).

 

Fexinidazole

Fexinidazole study, in adults and children, in-and out-patients  Phase III

NCT03025789  |  Democratic Republic of the Congo 

An open-label study assessing effectiveness, safety and compliance with fexinidazole in patients with human African trypanosomiasis due to T.b. Gambiense at any stage

Fexinidazole study in adults and children with HAT due to T.b. Rhodesiense Phase II/III

NCT03974178 | Malawi, Uganda

A multicentre, non-randomized clinical trial assessing effectiveness and safety of fexinidazole in adults and children with human African trypanosomiasis (HAT) due to T.b. Rhodesiense.

Fexinidazole study in children with both stage 1 + stage 2 HAT  Phase II/III

NCT02184689  |  Democratic Republic of the Congo | Completed

Efficacy and safety of fexinidazole in children at least 6 years old and weighing over 20 kg with human African trypanosomiasis (HAT) due to T.b. Gambiense: a prospective, multicentre, open study, plug-in to the Pivotal Study.

Fexinidazole in adults with stage 1 + early stage 2 HAT  Phase II/III

NCT02169557  |  Democratic Republic of the Congo | Completed

Efficacy and safety of fexinidazole in patients with stage 1 or early stage 2 human African trypanosomiasis (HAT) due to T.b. Gambiense: a prospective, multicentre, open-label cohort study, plug-in to the Pivotal Study.

Fexinidazole pivotal study Phase II/III

NCT01685827  |  Central African Republic, Democratic Republic of the Congo | Completed

Pivotal study of fexinidazole for human African trypanosomiasis in stage 2 (Phase II-III).

Fexinidazole – Bioequivalence study Phase I

NCT02571062  | France  |  Completed

Bioequivalence Study – Reference clinical fexinidazole tablet versus proposed market formulation.

Fexinidazole Phase I

NCT01340157  |  France  |  Completed

Fexinidazole (1200mg) bioavailability under different food intake conditions.

Fexinidazole  Phase I

NCT01483170  |  France  |  Terminated

Multiple dose study to evaluate security, tolerance and pharmacokinetic of fexinidazole (drug candidate for human African trypanosomiasis) administered with a loading dose and with food.

Fexinidazole  Phase I

NCT00982904  |  France  |  Completed

Human African trypanosomiasis: first-in-man clinical trial of a new medicinal product, fexinidazole.

 

 

NECT

NECT-FIELD study Phase IV

NCT00906880  |  Congo  |  Completed

Clinical study to assess the tolerability, feasibility and effectiveness of nifurtimox and eflornithine (NECT) for the treatment of T.b. Gambiense human African trypanosomiasis (HAT) in the meningo-encephalitic phase (NECT-FIELD).

Eflornithine-nifurtimox combination Phase III

NCT00146627  |  The Democratic Republic of the Congo  |  Completed

Efficacy – Clinical study comparing the nifurtimox-eflornithine combination with the standard eflornithine regimen for the treatment of T.b. Gambiense human African trypanosomiasis in the meningoencephalitic phase.

 

Last update: February 2018