Trials / Recruiting
RecruitingNCT06666491
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)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 2 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to collect efficacy and safety data to support the registration of tafenoquine in India.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tafenoquine | A single dose of TQ will be administered orally on Day 1 or Day 2. |
| DRUG | Primaquine | A single dose of PQ will be administered orally, daily, on Day 1 or 2 to Day 14 (or Day 15 if PQ started on Day 2). |
| DRUG | Chloroquine | A single dose of CQ will be administered orally, daily, on Days 1 to 3. |
Timeline
- Start date
- 2024-11-13
- Primary completion
- 2026-05-25
- Completion
- 2026-05-25
- First posted
- 2024-10-30
- Last updated
- 2025-08-07
Locations
4 sites across 1 country: India
Source: ClinicalTrials.gov record NCT06666491. Inclusion in this directory is not an endorsement.