Phase 3Recruiting
An Interventional Study to Compare the Efficacy and Safety of Tafenoquine (TQ) and Primaquine (PQ) When Either Are Taken Together With Chloroquine (CQ) for the Treatment of P. Vivax Malaria in Indian Participants Aged 2 Years and Older
A Randomized, Open-label, Multi-center, Interventional Phase 3 Study of the Efficacy and. Safety of Tafenoquine Compared to Primaquine (Both Co-administered With Chloroquine) for the Radical Cure (Relapse Prevention) of Plasmodium Vivax (P. Vivax) Malaria in Indian Participants (Pediatric and Adult Population)
- Sponsor
- GlaxoSmithKline (Industry)
- Enrolment
- 324 planned
- Conditions
- Malaria, Vivax
- Interventions
- Tafenoquine; Primaquine; Chloroquine
- Ages
- children, adults
- Registry
- NCT06666491
Full record on ClinicalTrials.gov
From the registry
The aim of this study is to collect efficacy and safety data to support the registration of tafenoquine in India.
Primary outcomes
- Number of participants remaining recurrence-free during the 6 months post-treatment and have a negative blood smear at the Month 6 (end of study [EOS]) visit
History
Primary completion expected
Last registry update
Started
Registered