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
Recruiting
Phase 3
Interventional Study
Malaria, Vivax
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 2 – 64
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 300 (estimated)
- Sponsor
- GlaxoSmithKline · Industry
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About This Trial
The aim of this study is to collect efficacy and safety data to support the registration of tafenoquine in India.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Males and females \>=2 years of age and under (\<) 65 years of age, weighing \>10 kg.
2. The participant has a positive malarial smear for P. vivax with a parasite density of \>100/microliter and \<100,000/microliter.
3. The participant has a screening Hb value \>8 g/dL.
4. T…
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