Safety and Tolerability Study of Acoziborole in g-HAT Seropositive Subjects

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Acoziborole as an oral, single-dose treatment was studied in an open-label pivotal Phase II/III trial (DNDi-OXA-02-HAT) in DRC and Guinea. The safety and efficacy results on g-HAT confirmed cases (all disease stages) from the pivotal study provided data, that allows to envision the treatment of confirmed g-HAT cases but there is still a gap in the management of g-HAT seropositive non-parasitologically confirmed individuals. Indeed, the standard g-HAT case definition implies the demonstration of the parasite in any body fluid via microscopy. However, there are factors such as low parasitaemia and the complexity and low sensitivity of parasitological methods that make such demonstration difficult. It has been demonstrated that a variable proportion (mainly depending on the prevalence) of such g-HAT "sero-suspects" are confirmed cases and, therefore, remaining as potential reservoirs of the parasite and a source of new infections hindering the efforts to eliminate the disease.

The present clinical trial intends to expand the safety data of acoziborole and complement the safety profile obtained from the pivotal trial by assessing the safety and tolerability of a single dose of acoziborole compared with placebo in seropositive individuals who are not confirmed parasitologically.

In addition to this study, an exploratory sub-study named 'TrypSkin' is planned to assess the presence of extravascular dermal T.b. gambiense in the population enrolled.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Drugs for Neglected Diseases

Criteria

Inclusion Criteria:

• Signed the informed consent form

• Male or female

• 15 years of age or older

• CATT test or HAT sero-K-set RDT positive

• Parasitology negative (in blood and/or lymph if lymphadenopathy is present)

• Karnofsky Performance Status above 70

• Able to ingest oral tablets

• Known address and/or contact details provided

• Must be able to comply with the schedule of follow-up visits and other requirements of the study

• Agreement to be hospitalised 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:

• Must agree to have protected sexual relations to avoid becoming pregnant from enrolment up to 3 months after dosing

• Negative urine pregnancy tests

Exclusion Criteria:

• Individuals parasitologically confirmed in blood and/or lymph

• Previously treated for g-HAT

• Severe malnutrition, defined as body mass index (BMI) <16 kg/m2

• Pregnant or breast-feeding women

• For women of childbearing potential:

• Urine pregnancy test positive

• Do not accept contraceptive protection 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, jeopardise the subject'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

• Known haemophilia