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

NCT06367361 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: SIDISI 201221U01AI155323
• Study Type: interventional
• Target: 336
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Fascioliasis

Outcome Measures

Primary Outcomes (3)

• Parasitological cure rate of chronic fascioliasis

  The cure rate will be expressed as the proportion of subjects in each arm with negative tests for Fasciola eggs.

  At day 30 post-treatment.

• Egg reduction rate day 7

  The egg reduction rate will be expressed as a percentage calculated comparing the visit egg count to the baseline egg count

  At day 7 post-treatment.

• Egg reduction rate day 30

  The egg reduction rate will be expressed as a percentage calculated comparing the visit egg count to the baseline egg count

  At day 30 post-treatment.

Secondary Outcomes (9)

• Safety information on day 0

  Day 0 after first dose of study medication.

• Safety information on day 3

  Day 3 after first dose of study medication.

• Safety information on day 7

  Day 7 after first dose of study medication.

• Safety information on day 30

  Day 30 after first dose of study medication.

• Laboratory safety information day 7

  Day 7 after first dose of study medication

Study Arms (3)

Oxfendazole single dose

EXPERIMENTAL

Oxfendazole 100 mg capsules at 20 mg/kg of body weight as a single oral dose administered with a lipid containing meal under direct observation.

Drug: Oxfendazole

Oxfendazole two doses

EXPERIMENTAL

Oxfendazole 100 mg capsules at 20 mg/kg of body weight per dose in two oral doses separated 24 hours each administered with a lipid containing meal under direct observation.

Drug: Oxfendazole

Triclabendazole

ACTIVE COMPARATOR

Triclabendazole 250 mg tablets at 10 mg/kg of body weight per dose in two oral doses separated 24 hours each administered with a lipid containing meal under direct observation.

Drug: Triclabendazole

Interventions

Oxfendazole DRUG

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.

Also known as: Fenbendazole sulfoxide, Synanthic

Oxfendazole single dose; Oxfendazole two doses

Triclabendazole DRUG

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.

Triclabendazole

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 QTc prolongation, or who are taking medications associates with 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.

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia: lead
• Oxfendazole Development Group: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

MeSH Terms

Conditions

Fascioliasis

Interventions

oxfendazole; Triclabendazole

Condition Hierarchy (Ancestors)

Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Liver Diseases, Parasitic; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Miguel M Cabada, MD MSc

  University of Texas

  STUDY CHAIR

• Lourdes Rodriguez, MD

  Asociacion CerviCusco

  PRINCIPAL INVESTIGATOR

• Hector H Garcia, MD PhD

  Universidad Peruana Cayetano Heredia

  STUDY CHAIR

Central Study Contacts

Miguel M Cabada, MD MSc

CONTACT

+1 409 747 0236; micabada@utmb.edu

Hector H Garcia, MD PhD

CONTACT

(511) 328-7360; hgarcia1@jhu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The laboratory personnel processing the stool microscopy tests will be blinded to the treatment assignment. Thus, the intervention will be blinded to the assessors of the primary endpoint.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Study arm 1: Oxfendazole 100 mg capsules at 20 mg/kg of body weight as a single oral dose administered with a lipid containing meal under direct observation. Study arm 2: Oxfendazole 100 mg capsules at 20 mg/kg of body weight per dose in two oral doses separated 24 hours each administered with a lipid containing meal under direct observation. Study arm 3: Triclabendazole 250 mg tablets at 10 mg/kg of body weight per dose in two oral doses separated 24 hours each administered with a lipid containing meal under direct observation.

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 16, 2024
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): March 15, 2029
• Study Completion (Estimated): March 15, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share