RecruitingPhase 3NCT06666491

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

Enrollment

300 participants

Start Date

Nov 13, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 2 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Chloroquine, a drug called Primaquine, and others for people with malaria, vivax. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 2 Years to 64 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTafenoquine

A single dose of TQ will be administered orally on Day 1 or Day 2.

DRUGPrimaquine

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).

DRUGChloroquine

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

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NCT06666491


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