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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Fascioliasis

Intervention / Treatment
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* Drug: Egaten (Triclabendazole) 250 mg tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent must be obtained before any study protocol specific assessment is performed. 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. Subjects < 18 years old, who are capable of providing assent, must provide assent with parental/legal guardian consent or as per local ethical guidelines. 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. 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: Subjects diagnosed with ectopic fascioliasis, extrahepatic involvement (e.g., lungs, spleen, pancreas, subcutaneous tissue, gastrointestinal organs, etc.). Subjects with known hypersensitivity to triclabendazole /other benzimidazole derivatives and/or any of the excipients in Egaten. Subjects taking any anthelmintic medications within two weeks or 5 half-lives, whichever is longer prior to enrolling into study. Inability or unwillingness to undergo study related procedures. 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 : Subjects who are machine operators or drivers. Medical history of liver (other than fascioliasis), kidney or cardiac disease. Females (including under the age of 18) known to be pregnant or testing positive for pregnancy at screening. Lactating women unwilling to discontinue lactation up to 72 hours after the second dose administration or as per local guidelines. Subjects requiring therapeutic drug monitoring of CYP2C19 substrate(s) (e.g. S-mephenytoin). 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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Egaten<br>All subjects will receive Egaten as two 10 mg/kg doses given 12 hours apart. | Drug: Egaten (Triclabendazole) 250 mg tablets<br>* Egaten 250 mg scored tablets for oral use.<br>* Other names: Triclabendazole;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with On-Treatments Adverse Events, Serious Adverse Events, and Deaths | Analysis of absolute and relative frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC) to demonstrate that Egaten administered as two 10 mg/kg doses given 12 hours apart in subjects with Fascioliasis is safe through the monitoring of relevant clinical and laboratory safety parameters. | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical cure rate in Acute Fascioliasis subjects over time. | The clinical cure rate in Acute Fasciolisis subjects will be measured by the proportion of subjects with: Resolution of baseline signs and symptoms. Improvement in baseline laboratory parameters. Improvement in baseline ultrasound findings. | Day 10, Day 30, Day 60 and Day 90 | 
| Parasitological cure rate in Chronic Fascioliasis subjects over time. | The parasitological cure rate in Chronic Fascioliasis subjects will be measured by the proportion of subjects with absence of fasciola eggs confirmed by stool examination. | Day 10, Day 30, Day 60 and Day 90 | 
| Clinical cure rate of Chronic Fascioliasis subjects over time. | The clinical cure rate in Chronic Fasciolisis subjects will be measured by the proportion of subjects with: Resolution of baseline signs and symptoms. Improvement in baseline laboratory parameters. Improvement in baseline ultrasound findings. | Day 10, Day 30, Day 60 and Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Fascioliasis, Chronic Fascioliasis, Clinical Cure, Parasitological Cure, Egaten, Triclabendazole, Post-Marketing commitment