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One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole in Chronic Fascioliasis

StatusNot Yet Recruiting
PhasePhase 2
Started
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Record History

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  1. Primary and study completion pushed from Mar 15, 2029 to Apr 15, 2029
    • Eligibility criteria expanded, about 4 words
    v10
  2. Primary and study completion dates: Mar 1, 2028 to Mar 15, 2029
    • Start date: Aug 30, 2025 to Aug 15, 2026
    • Eligibility criteria expanded, about 76 words
    v9
  3. Eligibility criteria shortened, about 48 wordsv8
  4. Start date: Jan 30, 2025 to Aug 30, 2025v7
  5. Study description expanded, about 34 words
    • Eligibility criteria expanded, about 4 words
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Re-verified, no change to tracked fieldsv5
  2. Collaborators: 1 to 2v4
  3. Primary completion date: Apr 30, 2027 to Mar 1, 2028v3
  4. Start date: Jul 2024 to Jan 30, 2025
    • Primary completion date: Mar 2028 to Apr 30, 2027
    • Study completion date: Mar 2028 to Mar 1, 2028
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Randomized clinical trial comparing the efficacy and safety of oxfendazole at 20 mg/kg per dose in one and two dose regimens with a two-dose regimen of triclabendazole at 10 mg/kg in an endemic region of the highlands of Peru. Adults with fascioliasis in rural communities will be screened for inclusion and exclusion criteria and a total of 336 subjects (112 per study arm) with chronic Fasciola infection will be enrolled and assigned randomly to the study arms in a 1:1:1 ratio. The primary efficacy (cure and egg reduction) endpoints will be assessed on day 7 and 30 post treatment. The secondary safety endpoint visits will be performed in days 0, 3, 7 and 30 post-treatment and Population Pharmacokinetics (PK) modeling studies will be performed in the first 24 hours after the first dose of oxfendazole.
Trial Details
NCT Number NCT06367361
Lead Sponsor Universidad Peruana Cayetano Heredia
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Oxfendazole Development Group
Conditions
(from sponsor)		 Fascioliasis
Related terms Fascioliasis
Enrollment 336 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov