Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage (NCT03025789) | Clinical Trial Compass
CompletedPhase 3
Fexinidazole in Human African Trypanosomiasis Due to T.b. Gambiense at Any Stage
Democratic Republic of the Congo, Guinea174 participantsStarted 2016-11-10
Plain-language 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.
Who can participate
Age range
6 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* Willing to undergo lumbar punctures.
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 complet…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants Whose Treatment Outcome at Month 18 is a Success
Timeframe: Between the first intake of fexinidazole (Day 1) and the end of the follow-up period (18 months)