One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole in Chronic Fas… (NCT06367361) | Clinical Trial Compass
Not Yet RecruitingPhase 2
One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole in Chronic Fascioliasis
336 participantsStarted 2026-08-15
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male and female subjects eighteen years or older with positive stool microscopy and/or egg counts confirmed by qualitative and/or quantitative stool microscopy performed within the past 14 days.
✓. Subjects capable of understanding the informed consent process and providing written informed consent.
✓. Willingness to give informed consent.
Exclusion criteria
✕. Subjects reporting previous treatment for fascioliasis
✕. Subjects with a stool egg count \> 300 eggs/g in stool samples
✕. Women with a positive urine pregnancy test or planning to become pregnant
✕. Women that are nursing
✕. Alanine aminotransferase (ALT) ≥ 3 or Aspartate aminotransferase (AST) ≥ 3 times above the upper limit of normal within 14 days before enrollment.
✕. Subjects with active cerebral cysticercosis determined by serology and imaging studies