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

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.

NCT Number	NCT06367361
Lead Sponsor	Universidad Peruana Cayetano Heredia Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Oxfendazole Development Group
Conditions	Fascioliasis
Enrollment	336 participants
Start Date	2026-08-15
Primary Completion	2029-04-15 (estimated)
Study Completion	2029-04-15 (estimated)
Updated on ClinicalTrials.gov	2026-06-03