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One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole in Chronic Fascioliasis
Sponsor: Universidad Peruana Cayetano Heredia
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.
Official title: Non-inferiority, Controlled, Randomized, Single-blind Study for Compare Regimens of One and Two Doses of Oxfendazole Versus a Schedule of Two Doses of Triclabendazole to Treat Chronic Fascioliasis
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
336
Start Date
2025-08-30
Completion Date
2028-03-01
Last Updated
2025-06-17
Healthy Volunteers
No
Conditions
Interventions
Oxfendazole
Human studies have shown that doses up to 60 mg/kg (approximately 3.6 g for a 60-kg human, which is considered the average weight of an adult in developing countries) are safe and that repeated doses of 15 mg/kg (approximately 900 mg for a 60-kg human) daily for 5 days are safe. A single dose of OXF results in significant plasma drug concentrations that reach a Cmax plateau after doses of 15 mg/kg.75 The dose to be studied in this trial is 20 mg/kg (1200 mg maximum dose), a dose only slightly higher than that achieving a Cmax plateau. This dose was conservatively selected to account for interindividual variation in plasma levels and deemed well tolerated and safe based on laboratory and ECG evaluations.
Triclabendazole
The standard of care for the treatment of fascioliasis according to the same guidelines is two 10 mg/kg doses of TCBZ 24 hours apart administered with a fat containing meal. The subjects in one of the arms of the study will receive this treatment as the standard of care. Subjects from any of the arms that fail to achieve parasitological cure will receive rescue treatment off the study with two doses of TCBZ as recommended by the Peruvian guidelines.