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

October 22, 2026 updated by: Novartis Pharmaceuticals

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This was an open-label, single-arm, multi-center multi-country, non-comparative study planned in adult and pediatric participants (≥ 6 years of age) with acute or chronic fascioliasis.

Screening/Baseline: Screening and baseline assessments were performed as per protocol.

Treatment phase: Enrolled participants were treated with two doses of 10 mg/kg triclabendazole given approximately 12 hours apart, with the first dose administered on Day 1 under site study team's supervision. The second dose was either taken at home (self-administered) or administered at the site.

Follow-up phase: Post-treatment at Day 3 and Day 6, the enrolled participants were followed for safety and tolerability. These visits were conducted by telephone, through home visits by qualified personnel, or through onsite visits, based on the investigator's discretion. During the post treatment study site visits at Day 10, Day 30, Day 60, and Day 90 (EOS visit), the enrolled participants were followed for safety, tolerability, and efficacy. On Day 15, Day 45, and Day 75, telephonic follow ups (primarily for safety) were conducted.

Study Type

Interventional

Enrollment (Actual)

301

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050010
        • Novartis Investigative Site
  • Egypt
      • Alexandria, Egypt, 21131
        • Novartis Investigative Site
    • Egypt
      • Cairo, Egypt, Egypt, 11617
        • Novartis Investigative Site
  • Peru
      • Cusco, Peru, 08002
        • Novartis Investigative Site
    • Lima region
      • San Martín de Porres, Lima region, Peru, 15102
        • Novartis Investigative Site
  • Turkey (Türkiye)
      • Sur, Turkey (Türkiye), 21280
        • Novartis Investigative Site
      • Van, Turkey (Türkiye), 65080
        • Novartis Investigative Site
    • Fatih
      • Istanbul, Fatih, Turkey (Türkiye), 34093
        • Novartis Investigative Site
    • Sehitkamil
      • Gaziantep, Sehitkamil, Turkey (Türkiye), 27310
        • Novartis Investigative Site
  • Vietnam
    • Binh Dinh
      • Qui Nhon, Binh Dinh, Vietnam, 590000
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Egaten

Triclabendazole was administered as two 10 mg/kg doses given approximately 12 hours apart. Both doses were administered orally with food.
Drug: Egaten (Triclabendazole) 250 mg tablets

Egaten 250 mg scored tablets for oral use.

Other Names:
  • Triclabendazole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Adverse events were reported from the first dose of study treatment until approximately 90 days thereafter.

Number of participants with treatment emergent adverse events (any AE regardless of seriousness), and SAEs.
Adverse events were reported from the first dose of study treatment until approximately 90 days thereafter.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Acute and Chronic Fascioliasis Participants Who Achieved Clinical Response
Time Frame: Baseline, Day 10

Clinical Response at Day 10 was defined as improvement or resolution of baseline signs and symptoms.

95% confidence interval (CI) is calculated based on Clopper-Pearson method.
Baseline, Day 10
Percentage of Acute Fascioliasis Participants Who Achieved Clinical Cure
Time Frame: Baseline, Day 30, Day 60 and Day 90

A participant was considered to achieve clinical cure if all of the following criteria were met.

  • Resolution of all sign and symptoms present at baseline
  • Improvement in ultrasound findings:

Abdomen - for hepatic lesions and/or biliary tract blockage caused by Fasciola worm(s)

• Improvement in the lab parameter from baseline: Eosinophil count: ≥ 50% reduction from baseline value or reaching normal range if baseline value was above normal range

95% confidence interval (CI) is calculated based on Clopper-Pearson method.
Baseline, Day 30, Day 60 and Day 90
Percentage of Chronic Fascioliasis Participants Who Achieved Clinical Cure
Time Frame: Baseline, Day 30, Day 60 and Day 90

A participant was considered to achieve clinical cure if all of the following criteria were met.

  • Resolution of all sign and symptoms present at baseline
  • Improvement in ultrasound findings: Abdomen - for hepatic lesions and/or biliary tract blockage caused by Fasciola worm(s)
  • Improvement in the lab parameter from baseline:

Eosinophil count: ≥50% reduction from baseline or reaching normal range if baseline value was above normal range Hemoglobin: ≥1 g/dL increase from baseline value or reaching normal range if baseline value was below normal range Liver function test: ≥1 grade improvement from baseline or reaching normal range for each test if baseline value was above normal range Erythrocyte sedimentation rate: ≥ 50% reduction from baseline or reaching normal range if baseline value was above normal range

95% CI is calculated based on Clopper-Pearson method.
Baseline, Day 30, Day 60 and Day 90
Percentage of Chronic Fascioliasis Participants Who Achieved Parasitological Cure
Time Frame: At Day 10, Day 30, Day 60 and Day 90

The parasitological cure rate in chronic fascioliasis participants was measured by the proportion of participants with absence of fasciola eggs confirmed by stool examination. In case of missing assessments at post baseline visits, parasitological cure is imputed as cured if two consecutive prior visits are negative, else parasitological cure is imputed as not cured. 95% confidence interval (CI) is calculated based on Clopper-Pearson method.
At Day 10, Day 30, Day 60 and Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2022

Primary Completion (Actual)

March 27, 2026

Study Completion (Actual)

March 27, 2026

Study Registration Dates

First Submitted

January 14, 2020

First Submitted That Met QC Criteria

January 14, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

November 6, 2026

Last Update Submitted That Met QC Criteria

October 22, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEGA230B2404

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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