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

Last updated: April 18, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

4

Condition

N/A

Treatment

Egaten (Triclabendazole) 250 mg tablets

Clinical Study ID

NCT04230148
CEGA230B2404
  • Ages 6-99
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent must be obtained before any study protocol specificassessment is performed.

  2. Parental/legal guardian informed consent must be obtained and signed forpediatric subjects (formally documented and witnessed, via an independenttrusted witness) prior to any study related procedure.

  3. Subjects < 18 years old, who are capable of providing assent, must provideassent with parental/legal guardian consent or as per local ethical guidelines.

  4. If the subject is unable to read and write or otherwise incapable of signing aninformed consent, then a witnessed consent according to local ethical standardsis permitted.

  5. Subjects (Adult and pediatric subjects ≥ 6 years of age and above 12.5 kg of weight)at time of consenting must have been diagnosed with fascioliasis based on clinicalsigns, symptoms and laboratory evaluations as per local clinical practice.

Exclusion

Exclusion Criteria:

  1. Subjects diagnosed with ectopic fascioliasis, extrahepatic involvement (e.g., lungs,spleen, pancreas, subcutaneous tissue, gastrointestinal organs, etc.).

  2. Subjects with known hypersensitivity to triclabendazole /other benzimidazolederivatives and/or any of the excipients in Egaten.

  3. Subjects taking any anthelmintic medications within two weeks or 5 half-lives,whichever is longer prior to enrolling into study.

  4. Inability or unwillingness to undergo study related procedures.

  5. Subjects who in the judgment of the Clinical Investigator are unsuitable for thetrial or who have to be excluded in order to be compliant with local fascioliasismanagement guidelines that may differ from the FDA approved label, including but notlimited to :

  6. Subjects who are machine operators or drivers.

  7. Medical history of liver (other than fascioliasis), kidney or cardiac disease.

  8. Females (including under the age of 18) known to be pregnant or testing positive forpregnancy at screening.

  9. Lactating women unwilling to discontinue lactation up to 72 hours after the seconddose administration or as per local guidelines.

  10. Subjects requiring therapeutic drug monitoring of CYP2C19 substrate(s) (e.g.S-mephenytoin).

  11. Subjects with medical history of QT prolongation or a history of symptoms compatiblewith a long QT interval or on medication which prolong the QT interval.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Egaten (Triclabendazole) 250 mg tablets
Phase: 4
Study Start date:
February 11, 2022
Estimated Completion Date:
March 18, 2026

Connect with a study center

  • Novartis Investigative Site

    Medellin, Antioquia 050010
    Colombia

    Active - Recruiting

  • Novartis Investigative Site

    Alexandria, 21131
    Egypt

    Active - Recruiting

  • Novartis Investigative Site

    Cairo, 11617
    Egypt

    Completed

  • Novartis Investigative Site

    San Martin de Porres, Lima 31
    Peru

    Completed

  • Novartis Investigative Site

    Cusco, 84
    Peru

    Active - Recruiting

  • Novartis Investigative Site

    Quy Nhon, Binh Dinh 590000
    Vietnam

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.