Last Updated: 29/10/2025
Registration of Tafenoquine in India (ReTaIn)
Objectives
The aim of this study is to compare the efficacy and safety of tafenoquine and primaquine, co-administered with chloroquine, in P. vivax malaria patients in India.
* Official Title: 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)
ClinicalTrials.gov ID: NCT06666491
- Open -label 1:1 randomization to either:
- Single dose tafenoquine + 3-day chloroquine; or
- 14-day primaquine (3.5 mg/kg total dose) + 3-day chloroquine.
- Aim is to recruit ~ 300 participants
- 6 months follow up
- Phase 3 study
The study will initially enroll participants aged 12 years and older, weighing at least 35 kg. After an interim safety analysis of the first 20 participants aged 12–18, reviewed by an Independent Data Safety Monitoring Committee (IDMC), a decision will be made on whether to expand enrolment to children aged 2 to <12 years and weighing >10 kg to <35 kg.
Nov 2024 — May 2026
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