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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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later May 25, 2026 → May 14, 2027
See other at-risk trials from GlaxoSmithKline

Record History

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  1. Primary and study completion pushed from May 25, 2026 to May 14, 2027 Show 4 more changesShow less
    • Enrollment target: 300 to 324
    • Study sites: 4 to 5
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 12 of 26 entries
  2. Study sites: 2 to 4
    • Primary and study completion dates: Jul 6, 2026 to May 25, 2026
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 5 to 2
    • Primary and study completion dates: Apr 15, 2026 to Jul 6, 2026
    • Start date changed from estimate of Nov 7, 2024 to Nov 13, 2024
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
GlaxoSmithKline
246 trials monitored
See 20 trials at risk
The aim of this study is to collect efficacy and safety data to support the registration of tafenoquine in India.
Trial Details
NCT Number NCT06666491
Lead Sponsor GlaxoSmithKline
Conditions
(from sponsor)		 Malaria, Vivax
Related terms Malaria, Vivax
Enrollment 324 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov