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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

NCT06666491 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-08-07

No results posted yet for this study

Summary

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

Conditions

  • Malaria, Vivax

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-13
Primary Completion
2026-05-25
Completion
2026-05-25

Countries

  • India

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06666491 on ClinicalTrials.gov