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
Launched by DRUGS FOR NEGLECTED DISEASES · Jul 8, 2014
Trial Information
Current as of July 23, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Informed consent form signed by one of the parents or the child's legal representative
- • Child assent to participate in the study collected in the presence of an impartial witness
- • Age between 6 and 15 years old
- • \> 20 Kg bodyweight
- • Boy or girl
- • Able to ingest at least one complete meal per day (or at least one Plumpy'Nut® sachet)
- • Able to swallow 600mg fexinidazole tablets
- • Karnofsky index \> 50
- • Presence of trypanosomes in blood and/or lymph and/or CSF
- • Permanent address and ability to comply with follow-up visit schedule
- Exclusion Criteria:
- • Child refusing to be included in the trial
- • Bodyweight \< 20 Kg
- • Severe malnutrition, defined as having a BMI below 16 (- 2 Z-score of the norm according to WHO 2007 Growth reference data)
- • Inability to take oral medication
- • Pregnancy or breastfeeding
- • Clinically relevant medical condition other than HAT that, in the Investigator's opinion, may jeopardize subject safety or interfere with participation in the study, including but not limited to significant liver or cardiovascular disease, active documented or suspected infection, central nervous system (CNS) trauma or seizure disorders, coma or altered consciousness
- • Severely deteriorated general condition, such as cardiovascular shock, respiratory distress, or terminal illness
- • Any medical condition (except HAT-specific symptoms) hindering communication with the Investigator as required for the completion of this study
- • Any contraindication to imidazole products (known hypersensitivity to imidazoles)
- • History of HAT treatment in the past 2 years
- • Patients previously enrolled in the study or having already received fexinidazole.
- • Expected follow-up difficulties (migrants, refugees, itinerant vendors, etc.).
- • Current alcohol or drug abuse
- • Clinically significant abnormal laboratory findings, including ASAT and/or ALAT \> 2 times ULN // Total bilirubin \> 1.5 times ULN // Severe leukopenia (\< 2000/mm3) // Potassium (K+) \< 3.5 mmol // Any other clinically significant abnormal laboratory value (see details in Investigator Manual)
- • Pregnancy confirmed by a positive urine pregnancy test obtained within 24 hours (h) prior to start of study treatment (see Section 5.8.3 Contraception; p36) for girls over 12 years old and over
- • ECG abnormalities assessed by a central cardiologist
- • QTcF≥ 450 ms, as measured automatically (if first measurement is abnormal, a second assessment will be done at least 10-20 min later, with the patient in resting position).
- • Patients not tested for malaria and/or not treated adequately for this infection
- • Patients not treated adequately for soil transmitted helminthic diseases
About Drugs For Neglected Diseases
Drugs for Neglected Diseases (DNDi) is a pioneering non-profit research and development organization dedicated to addressing the critical gap in treatment options for neglected diseases affecting impoverished populations worldwide. By fostering innovative partnerships and collaborative research, DNDi aims to accelerate the discovery and development of safe, effective, and affordable medicines for diseases such as malaria, sleeping sickness, and leishmaniasis. Committed to equitable access, DNDi works to ensure that the benefits of its research reach those who need them most, ultimately contributing to global health equity and improved health outcomes in underserved communities.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Kinshasa, , Congo, The Democratic Republic Of The
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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