Phase
Condition
N/ATreatment
Egaten (Triclabendazole) 250 mg tablets
Clinical Study ID
Ages 6-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written informed consent must be obtained before any study protocol specificassessment is performed.
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.
Subjects < 18 years old, who are capable of providing assent, must provideassent 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 aninformed consent, then a witnessed consent according to local ethical standardsis 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 clinicalsigns, symptoms and laboratory evaluations as per local clinical practice.
Exclusion
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 benzimidazolederivatives 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 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 :
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 forpregnancy at screening.
Lactating women unwilling to discontinue lactation up to 72 hours after the seconddose 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 compatiblewith a long QT interval or on medication which prolong the QT interval.
Study Design
Connect with a study center
Novartis Investigative Site
Medellin, Antioquia 050010
ColombiaActive - Recruiting
Novartis Investigative Site
Alexandria, 21131
EgyptActive - Recruiting
Novartis Investigative Site
Cairo, 11617
EgyptCompleted
Novartis Investigative Site
San Martin de Porres, Lima 31
PeruCompleted
Novartis Investigative Site
Cusco, 84
PeruActive - Recruiting
Novartis Investigative Site
Quy Nhon, Binh Dinh 590000
VietnamActive - Recruiting
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