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Efficacy and Safety of Ascending Doses of Arpraziquantel in Children Infected With Opisthorchis Viverrini

Study acronym: ADORA-VI
StatusRecruiting
PhasePhase 2
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Recruitment opened
    • Start date changed from estimate of Jul 20, 2026 to Jul 22, 2026
    • Site details revised
    v4
  2. Start date: Apr 15, 2026 to Jul 20, 2026
    • Primary and study completion pushed from Aug 2026 to Oct 2026
    v3
  3. Primary and study completion dates: Feb 1, 2026 to Aug 2026v2 Show 4 more changesShow less
    • Start date: Dec 15, 2025 to Apr 15, 2026
    • Interventions: Apraziquantel (Drug), Placebo (Drug) to Apraziquantel (Drug)
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: details revised at 2 of 2 entries
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This study aims to assess the efficacy, safety and acceptability of ascending doses of arpraziquantel in children infected with Opisthorchis viverrini. The primary objective is to determine the dose-response relationship in terms of cure rate. This study will involve children aged 6-7 years, since O. viverrini infections often occur in pre-school and school-aged children, and this group is largely left untreated in current public health programs.
Trial Details
NCT Number NCT07262814
Lead Sponsor Jennifer Keiser
Collaborators: Lao Tropical and Public Health Institute
Conditions
(from sponsor)		 Opisthorchis Viverrini
Enrollment 125 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov