Evaluating the safety and effectiveness of Egaten for treating fascioliasis in patients aged 6 and 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.

This study is testing if Egaten can safely and effectively treat fascioliasis in patients aged 6 and older.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 6 Years to 99 Years
• Sex: All
• Sponsor: Novartis (Industry-sponsored)
• Locations: 6 sites (Medellin, Antioquia and 5 other locations)
• Trial ID: NCT04230148 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label study aims to assess the safety, tolerability, and clinical outcomes of Egaten (Triclabendazole) in approximately 300 patients diagnosed with fascioliasis, including both acute and chronic cases. Participants will receive two doses of 10 mg/kg of Egaten, administered 12 hours apart, and will be monitored for safety and efficacy through a series of follow-up visits over 90 days. The study includes both adult and pediatric patients, ensuring a comprehensive evaluation of the treatment's impact across different age groups.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 6 years and older who have been diagnosed with fascioliasis.

Not a fit: Patients with ectopic fascioliasis or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective treatment option for patients suffering from fascioliasis, potentially leading to improved health outcomes.

How similar studies have performed: While this approach has been used in other studies, the specific application of Egaten for fascioliasis in this population is being evaluated for the first time in this context.

Eligibility criteria

Inclusion Criteria:

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

   1. Parental/legal guardian informed consent must be obtained and signed for pediatric subjects (formally documented and witnessed, via an independent trusted witness) prior to any study related procedure.
   2. Subjects \< 18 years old, who are capable of providing assent, must provide assent with parental/legal guardian consent or as per local ethical guidelines.
   3. If the subject is unable to read and write or otherwise incapable of signing an informed consent, then a witnessed consent according to local ethical standards is permitted.
2. 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 clinical signs, symptoms and laboratory evaluations as per local clinical practice.

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 benzimidazole derivatives 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 the trial or who have to be excluded in order to be compliant with local fascioliasis management guidelines that may differ from the FDA approved label, including but not limited to :

   1. Subjects who are machine operators or drivers.
   2. Medical history of liver (other than fascioliasis), kidney or cardiac disease.
6. Females (including under the age of 18) known to be pregnant or testing positive for pregnancy at screening.
7. Lactating women unwilling to discontinue lactation up to 72 hours after the second dose administration or as per local guidelines.
8. Subjects requiring therapeutic drug monitoring of CYP2C19 substrate(s) (e.g. S-mephenytoin).
9. Subjects with medical history of QT prolongation or a history of symptoms compatible with a long QT interval or on medication which prolong the QT interval.

Where this trial is running

Medellin, Antioquia and 5 other locations

• Novartis Investigative Site — Medellin, Antioquia, Colombia (Recruiting)
• Novartis Investigative Site — Alexandria, Egypt (Recruiting)
• Novartis Investigative Site — Cairo, Egypt (Completed)
• Novartis Investigative Site — San Martin de Porres, Lima, Peru (Completed)
• Novartis Investigative Site — Cusco, Peru (Recruiting)
• Novartis Investigative Site — Quy Nhon, Binh Dinh, Vietnam (Recruiting)

Study contacts

• Study coordinator: Novartis Pharmaceuticals

Conditions Fascioliasis; Acute Fascioliasis; Chronic Fascioliasis; Clinical Cure; Parasitological Cure; Egaten; Triclabendazole; Post-Marketing commitment