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

NCT04230148 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2026-05-14

No results posted yet for this study

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

DRUG

Egaten (Triclabendazole) 250 mg tablets

Egaten 250 mg scored tablets for oral use.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-11
Primary Completion
2026-03-27
Completion
2026-03-27
FDA Drug
Yes

Countries

  • Colombia
  • Egypt
  • Peru
  • Turkey (Türkiye)
  • Vietnam

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04230148 on ClinicalTrials.gov