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

Starting soon · Phase 2

Conditions studied: Fascioliasis

In brief

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.

Key facts

Study ID

NCT06367361

Run by

Universidad Peruana Cayetano Heredia

People needed

336

Starts

2026-08-15

Expected to finish

2029-04-15

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• Subjects with known liver disease, liver cirrhosis, or end stage renal disease
• Subjects with known allergy or AEs to benzimidazole drugs
• Subjects taking carbamazepine, phenobarbital, phenytoin, or other medication known to decrease the serum concentrations of benzimidazoles.
• Women unable or unwilling to use an acceptable birth control method.
• Male volunteers who are unwilling to ensure pregnancy prevention in their partner.
• Volunteers with a previously recorded electrocardiogram showing heart-rate corrected (QTc) prolongation, or who are taking medications associates with heart-rate corrected (QTc) prolongation, such as selective serotonin reuptake inhibitors, quinolones, or macrolides.
• Volunteers with acute fascioliasis.
• Volunteers who fail to demonstrate adequate understanding of the study after three attempts.

Full record on ClinicalTrials.gov

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