- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04230148
Study of Safety, Tolerability and Clinical Outcomes of Egaten in Fascioliasis Patients (6 Years of Age or 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Novartis Pharmaceuticals
- Phone Number: +41613241111
- Email: novartis.email@novartis.com
Study Contact Backup
- Name: Novartis Pharmaceuticals
Study Locations
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Antioquia
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Medellin, Antioquia, Colombia, 050010
- Recruiting
- Novartis Investigative Site
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Alexandria, Egypt, 21131
- Recruiting
- Novartis Investigative Site
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Cairo, Egypt, 11617
- Recruiting
- Novartis Investigative Site
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Cusco, Peru, 84
- Recruiting
- Novartis Investigative Site
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Lima
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San Martin de Porres, Lima, Peru, 31
- Recruiting
- Novartis Investigative Site
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Binh Dinh
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Quy Nhon, Binh Dinh, Vietnam, 590000
- Recruiting
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
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
All subjects will receive Egaten as two 10 mg/kg doses given 12 hours apart.
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Egaten 250 mg scored tablets for oral use.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with On-Treatments Adverse Events, Serious Adverse Events, and Deaths
Time Frame: Day 90
|
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.
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Day 90
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical cure rate in Acute Fascioliasis subjects over time.
Time Frame: Day 10, Day 30, Day 60 and Day 90
|
The clinical cure rate in Acute Fasciolisis subjects will be measured by the proportion of subjects with:
|
Day 10, Day 30, Day 60 and Day 90
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Parasitological cure rate in Chronic Fascioliasis subjects over time.
Time Frame: Day 10, Day 30, Day 60 and Day 90
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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.
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Day 10, Day 30, Day 60 and Day 90
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Clinical cure rate of Chronic Fascioliasis subjects over time.
Time Frame: Day 10, Day 30, Day 60 and Day 90
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The clinical cure rate in Chronic Fasciolisis subjects will be measured by the proportion of subjects with:
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Day 10, Day 30, Day 60 and Day 90
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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
Studies a U.S. FDA-regulated device product
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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