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

NCT03025789 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2025-01-08

Study results available
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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.

Conditions

  • Trypanosomiasis, African
  • Sleeping Sickness
  • Trypanosomiasis; Gambian

Interventions

DRUG

Fexinidazole

Tablets of 600 mg; Participants with a weight between 20 and 34 kg received 1200 mg (2 tablets) for 4 days, then 600 mg (1 tablet) for 6 days (with food); Participants with a weight of 35 kg and above received 1800 mg (3 tablets) for 4 days, then 1200 mg (2 tablets) for 6 days (with food)

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Victor Kande Betu Kumeso, MD · Ministry of Health, Kinshasa, The Democratic Republic of the Congo

  • Mamadou Camara, PhD · National HAT Control Programme, Conakry, Guinea

  • Médard Ilunga Wa Kyhi, MD · National HAT Control Programme, Kinshasa, The Democratic Republic of the Congo

  • Digas Ngolo Tete, MPH · National HAT Control Programme, Kinshasa, The Democratic Republic of the Congo

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-10
Primary Completion
2021-02-01
Completion
2021-02-01

Countries

  • Democratic Republic of the Congo
  • Guinea

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03025789 on ClinicalTrials.gov