NCT04230148

Study of Safety, Tolerability and Clinical Outcomes of Egaten in Fascioliasis Patients (6 Years of Age or Older).

A Phase IV, Multi-center, Open-label Study to Determine the Safety, Tolerability and Clinical Outcomes Following Oral Administration of EGATEN™ (Triclabendazole) in Patients (6 Years of Age or Older) With Fascioliasis.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 301 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 6 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open label, non-comparative, single arm multi-country study in approximately 300 adult and pediatric subjects (≥ 6 years of age) with fascioliasis. The study population consists of male and female adult and pediatric patients (≥ 6 years of age). The study will enroll approximately 300 subjects with acute (minimum 15% of overall study population) or chronic fascioliasis. Enrolled subjects will receive two doses of 10 mg/kg of Egaten given approximately 12 hours apart. Subjects will be treated and followed up on an outpatient basis. After screening and post treatment, at Day 3 and Day 6 the subjects will be followed for safety and tolerability. These visits are primarily for safety follow up and may be telephonic or home visit by qualified personnel or onsite visits based on the investigator's discretion. During visits Day 10, Day 30, Day 60 and Day 90 post-treatment, the subjects will be followed for safety, tolerability and efficacy. On Day 15, Day 45 and Day 75, telephonic follow-up (primarily for safety) will be conducted.

Conditions

• Fascioliasis

Interventions

Type	Name	Description
DRUG	Egaten (Triclabendazole) 250 mg tablets	Egaten 250 mg scored tablets for oral use.

Timeline

• Start date: 2022-02-11
• Primary completion: 2026-03-27
• Completion: 2026-03-27
• First posted: 2020-01-18
• Last updated: 2026-04-02

Locations

10 sites across 5 countries: Colombia, Egypt, Peru, Turkey (Türkiye), Vietnam

Regulatory

• FDA-regulated drug study