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Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage

Trypanosomiasis, African Clinical Trial

Official title:
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

Clinical Trial Summary

This study evaluates the effectiveness of fexinidazole administered to patients with human African trypanosomiasis due to T. b. gambiense (g-HAT) at all stages of the disease. The aim of the present study is to provide additional information on the effectiveness and safety of fexinidazole and to assess its use under conditions as close as possible to those in real life, both in patients treated on an out-patient basis and in the hospital setting, depending on clinical status. Participants will receive fexinidazole oral treatment for 10 days. Regular blood draws and lumbar punctures will be performed over 18 months to confirm the cure of the disease. Other assessments will include the recording of adverse events, signs and symptoms of the disease, laboratory tests, vital signs, electrocardiograms. Treatment compliance, feasibility, and packaging acceptability will be thoroughly assessed in the participants receiving treatment at home. Those participants will complete questionnaires to check that instructions for fexinidazole administration are clear enough and followed correctly.

Clinical Trial Description

See attached protocol. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03025789
Study type Interventional
Source Drugs for Neglected Diseases
Contact
Status Completed
Phase Phase 3
Start date November 10, 2016
Completion date February 1, 2021
View Details
See also
  Status Clinical Trial Phase
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Terminated NCT00489658 - Eflornithine + Nifurtimox Late-Stage Human African Trypanosomiasis (HAT)in West Nile, Uganda Phase 2/Phase 3
Completed NCT03087955 - Prospective Study on Efficacy and Safety of Acoziborole (SCYX-7158) in Patients Infected by Human African Trypanosomiasis Due to T.b. Gambiense Phase 2/Phase 3
Completed NCT02571062 - Bioequivalence Study - Reference Clinical Fexinidazole Tablet Versus Proposed Market Formulation Phase 1
Terminated NCT00330148 - Randomized Clinical Trial of Three Drug Combinations for Late-Stage Gambiense Human African Trypanosomiasis Phase 3
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Completed NCT05947604 - DDI Study of Single Oral Dose of Acoziborole With Sequential Co-administration of Midazolam and Dextromethorphan Phase 1
Completed NCT01533961 - Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the SCYX-7158 Phase 1
Completed NCT05256017 - Safety and Tolerability Study of Acoziborole in g-HAT Seropositive Subjects Phase 2/Phase 3
Completed NCT00802594 - A Trial of DB289 for the Treatment of Stage I African Trypanosomiasis Phase 2
Completed NCT00146627 - Efficacy - Safety of Eflornithine-Nifurtimox Combination Versus Eflornithine to Treat Human African Trypanosomiasis Phase 3