Status:
COMPLETED
Safety and Tolerability Study of Acoziborole in g-HAT Seropositive Subjects
Lead Sponsor:
Drugs for Neglected Diseases
Conditions:
Trypanosomiasis, African
Trypanosoma Brucei Gambiense; Infection
Eligibility:
All Genders
15+ years
Phase:
PHASE2
PHASE3
Brief Summary
Human African trypanosomiasis (HAT) or sleeping sickness is a tropical disease which is endemic in sub-Saharan Africa. Most cases of HAT are due to the parasite Trypanosoma brucei gambiense (T.b. gamb...
Detailed Description
HAT, or sleeping sickness, is a neglected tropical disease which is endemic in sub Saharan Africa. This vector-borne parasitic disease is transmitted by the bite of the tsetse fly and can be fatal wit...
Eligibility Criteria
Inclusion
- Signed the informed consent form (ICF)
- Male or female
- 15 years of age or older
- Card agglutination test for trypanosomiasis (CATT) test or HAT sero-K-set rapid diagnostic test (RDT) positive
- Parasitology negative (in blood and/or lymph node aspirate \[if lymphadenopathy is present\])
- Karnofsky performance status above 70
- Able to ingest oral tablets
- Known address and/or contact details provided
- Able to comply with the schedule of follow-up visits and other requirements of the study
- Agreement to be hospitalized upon enrolment for at least 5 days (in order to receive in-ward post-treatment observational follow-up through the first 5 days after treatment)
- Agreement to not take part in any other clinical trials during the participation in this study
- For women of childbearing potential:
- Agreed to have protected sexual relations to avoid becoming pregnant from enrolment up to 3 months after dosing (contraceptive protection was advised and offered at no cost)
- Negative urine pregnancy tests (before dosing at site level)
Exclusion
- Individuals parasitologically confirmed in blood and/or lymph
- Previously treated for g-HAT
- Severe malnutrition, defined as body mass index (BMI) \<16 kg/m\^2
- Pregnant or breast-feeding women
- For women of childbearing potential:
- Urine pregnancy test positive
- Did not accept contraceptive protection (i.e. condom or sexual abstinence) from enrolment up to 3 months after dosing
- Clinically significant medical condition and/or abnormal laboratory results that could, in the opinion of the Investigator, jeopardize the participant's safety or participation in the study
- Additional exclusion criteria for the TrypSkin exploratory sub-study:
- Rejection to participate in the exploratory sub-study in the signed ICF
- Known diabetes mellitus
- Known hemophilia
Key Trial Info
Start Date :
December 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2023
Estimated Enrollment :
1208 Patients enrolled
Trial Details
Trial ID
NCT05256017
Start Date
December 30 2021
End Date
August 3 2023
Last Update
March 20 2025
Active Locations (7)
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1
General Referral Hospital of Bagata
Bagata, Bandundu, Democratic Republic of the Congo
2
Hospital of Dipumba
Mbuji-Mayi, East Kasai, Democratic Republic of the Congo
3
General Referral Hospital of Idiofa
Idiofa, Kwilu, Democratic Republic of the Congo
4
General Referral Hospital of Masi-Manimba
Masi-Manimba, Kwilu, Democratic Republic of the Congo