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COMPLETED
NCT04230148
PHASE4

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

The study evaluated safety and tolerability along with clinical outcomes of Egaten administered as per the FDA approved dosing regimen of 2 doses of 10 mg/kg (given approximately 12 hours apart) in Fascioliasis participants (≥ 6 years of age).

Official title: 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.

Key Details

Gender

All

Age Range

6 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

301

Start Date

2022-02-11

Completion Date

2026-03-27

Last Updated

2026-10-06

Healthy Volunteers

No

Conditions

Interventions

DRUG

Egaten (Triclabendazole) 250 mg tablets

Egaten 250 mg scored tablets for oral use.

Locations (10)

Novartis Investigative Site

Medellín, Antioquia, Colombia

Novartis Investigative Site

Cairo, Egypt, Egypt

Novartis Investigative Site

Alexandria, Egypt

Novartis Investigative Site

San Martín de Porres, Lima region, Peru

Novartis Investigative Site

Cusco, Peru

Novartis Investigative Site

Istanbul, Fatih, Turkey (Türkiye)

Novartis Investigative Site

Gaziantep, Sehitkamil, Turkey (Türkiye)

Novartis Investigative Site

Sur, Turkey (Türkiye)

Novartis Investigative Site

Van, Turkey (Türkiye)

Novartis Investigative Site

Qui Nhon, Binh Dinh, Vietnam