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RECRUITING
NCT06666491
PHASE3

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The aim of this study is to collect efficacy and safety data to support the registration of tafenoquine 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)

Key Details

Gender

All

Age Range

2 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2024-11-13

Completion Date

2026-05-25

Last Updated

2025-08-07

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (4)

GSK Investigational Site

Ahmedabad, India

GSK Investigational Site

Kolkata, India

GSK Investigational Site

Mumbai, India

GSK Investigational Site

Surat, India