Clinical Trials Directory

Trials / Completed

CompletedNCT02184689

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

Status
Completed
Phase
Phase 2 / Phase 3
Study type
Interventional
Enrollment
125 (actual)
Sponsor
Drugs for Neglected Diseases · Academic / Other
Sex
All
Age
6 Years – 14 Years
Healthy volunteers
Not accepted

Summary

The aim of the study is to assess the efficacy and safety of an oral regimen of fexinidazole (once daily for 10 days) in the treatment of stage 1 and stage 2 T.b. gambiense sleeping sickness in children at least 6 years old and over 20 kg bodyweight.

Conditions

Interventions

TypeNameDescription
DRUGfexinidazole

Timeline

Start date
2014-05-03
Primary completion
2016-12-14
Completion
2017-06-27
First posted
2014-07-09
Last updated
2020-06-24

Locations

1 site across 1 country: Democratic Republic of the Congo

Source: ClinicalTrials.gov record NCT02184689. Inclusion in this directory is not an endorsement.