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Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT03025789•Drugs for Neglected Diseases

View on ClinicalTrials.gov

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.

Detailed Description

See attached protocol.

Eligibility

Age

6 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female patient, including breastfeeding or pregnant women in the second or third trimester.
•≥ 6 years of age.
•≥ 20 kg body weight.
•Signed Informed Consent Form and Assent Form for patients less than 18 years of age
•Trypanosomes detected in any body fluid.
•Physically able to ingest at least one solid meal per day.
•Able to take oral medication.
•Karnofsky Performance Status \> 40%.
•Able to comply with the schedule of follow-up visits and with the study constraints.
•Easily reachable during the out-patient follow-up period.
+14 more criteria

Exclusion Criteria

•Active clinically relevant medical conditions other than HAT that, in the Investigator's opinion, could jeopardize patient safety or interfere with participation in the study, including but not limited to significant liver or cardiovascular diseases, human immunodeficiency virus (HIV) infection, central nervous system (CNS) trauma or seizure disorders, coma or altered consciousness not related to HAT.
•Severe renal or hepatic impairment defined as:
•elevated creatinine at \> 3 times the upper limit of normal (ULN); elevated alanine aminotranferase (ALT), aspartate aminotransferase (AST), or bilirubin at \> 3 ULN
•Severely deteriorated general condition, such as cardiovascular shock, respiratory distress or terminal illness.
•Any condition (except symptoms of HAT) that compromises ability to communicate with the Investigator as required for completion of the study.
•Any contraindication to imidazole products (known hypersensitivity to imidazoles).
•Treatment for HAT within 2 years prior to inclusion.
•Prior enrolment in the study or prior intake of fexinidazole.
•Foreseeable difficulty in complying with the schedule of follow-up visits (migrants, refugees, itinerant traders, etc.).

Locations (8)

Dipumba Hospital

Mbuji-Mayi, Kasaï Oriental Province, Democratic Republic of the Congo

Bagata Hospital

Bagata, Kwilu, Democratic Republic of the Congo

Bandundu Hospital

Bandundu Province, Kwilu, Democratic Republic of the Congo

Masi Manimba Hospital

Masi-Manimba, Kwilu, Democratic Republic of the Congo

Nkara Secondary Hospital

Nkara, Kwilu, Democratic Republic of the Congo

Mushie Hospital

Mushie, Maï Ndombe Province, Democratic Republic of the Congo

Roi Baudouin Hospital

Kinshasa, Democratic Republic of the Congo

Dubreka Hospital

Dubréka, Guinea

Key Dates

Start Date

November 10, 2016

Primary Completion Date

February 1, 2021

Completion Date

February 1, 2021

Last Updated

January 8, 2025

Enrollment

174

ACTUAL participants

Conditions

Trypanosomiasis, AfricanSleeping SicknessTrypanosomiasis; Gambian

Interventions

Fexinidazole

DRUG

Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: Early Test-of-cure

NCT03112655

African TrypanosomiasisAfrican; Trypanosomiasis, West+2 more

View study

TERMINATEDPHASE1

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

NCT01483170

Trypanosomiasis, African

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Diagnostic Tools for Human African Trypanosomiasis Elimination and Clinical Trials: Early Test-of-cure

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

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A Trial of DB289 for the Treatment of Stage I African Trypanosomiasis

Randomized Clinical Trial of Three Drug Combinations for Late-Stage Gambiense Human African Trypanosomiasis