Human African Trypanosomiasis due to T.b. gambiense Human African Trypanosomiasis due to T.b. gambiense
Conditions
Interventions
Sponsors
DNDi
Eligibility
Sex/Gender
All
Inclusion criteria
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 * 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. Eligibility Criteria for Out-patient Treatment: - Accepting to be treated on an out-patient basis. - Karnofsky Performance Status > 50%. - Good understanding of the method of administration of fexinidazole by the patient and/or caregiver (checked using a questionnaire at the time of IMP dispensing). - Residing close to the investigational centre, i.e. approximately one hour by road and/or boat, during the treatment period*. - Easily reachable during the treatment period. - No medical or psychiatric contraindications for treatment as out-patient. - No pregnancy or breastfeeding. - No neurological symptoms. *The patient (and caregiver) is permitted to reside in a place different from his/her main place of residence during the treatment period.
Exclusion criteria
Exclusion criteria: * Active clinically relevant medical conditions other than HAT that, in the Investigator¿s opinion, could jeopardise patient safety or interfere with participation in the study, including but not limited to significant liver or cardiovascular diseases, HIV infection, CNS trauma or seizure disorders, coma or altered consciousness not related to HAT. * Severe renal or hepatic impairment defined as: o elevated creatinine at > 3 times the upper limit of normal (ULN) o elevated ALT, 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.). Temporary Non-inclusion Criteria: * Recovery period after antimalarial treatment and/or treatment of helminthiasis (at least 3 days). * Uncontrolled diabetes or hypertension or any patients requiring clinical stabilisation; wait until appropriate treatment to control the disease has been initiated. * First trimester of pregnancy. * Traumatic lumbar puncture at Screening i.e. red blood cells visible in CSF; wait for 48 hours before repeating lumbar puncture.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success or failure for patients any stage HAT | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of grade ¿ 3 adverse events (AEs);Occurrence of any serious adverse event (SAE);PK measure: Presence of fexinidazole and/or its main metabolites in the blood for PK analyses;Outpatients compliance: Number of tablets left over and patient's responses to the questionnaire;Outpatients compliance: Patient's responses to the questionnaire;Feasibility of self-management of treatment intake in outpatients based on interview and left over tablets at D11;questionnaire on acceptability of packaging for outpatients only questionnaire to be completed by patients and caregivers;Whole blood concentration of fexinidazole and its metabolites from dry blood spot of inpatients | — |
Countries
Democratic Republic of the Congo
Contacts
Public ContactAntoine Tarral
Head of HAT Clinical Program/DNDi
Outcome results
None listed