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STROgHAT: Acoziborole for gHAT Transmission Interruption
NCT06356974Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Apr 2024
- Primary completion
- Dec 2026
- Sponsor
- Drugs for Neglected Diseases initiative
- Modality
- Small Molecules
- Drugs
- acoziborole
- Conditions
- human African trypanosomiasis (HAT)
01
Overview
Phase 3, open-label, single-arm trial of acoziborole in human African trypanosomiasis (HAT), sponsored by Drugs for Neglected Diseases initiative. Primary endpoints: Interruption of transmission of T.b. gambiense at 4 years and Assessment of safety at 3 years. Planned start Apr 2024; status: not yet recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment of seropositives
Single dose acoziborole for seropositive, parasitologically negative individuals.
03
Who it enrols
Seropositive for gHAT (CATT or RDT positive) but parasitologically negative, aged 11 years or older, weighing at least 30 kg.
04
Endpoints
Primary
Interruption of transmission of T.b. gambiense
Assessment of safety
Secondary
Economic evaluation
Assessment of the performance of several diagnostic tests
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