STUDY OF SAFETY, TOLERABILITY AND EFFICACY OF EGATEN IN FASCIOLIASIS PATIENTS (6YEARS OF AGE OR OLDER).
- Conditions
- -B663 FascioliasisFascioliasisB663
- Registration Number
- PER-058-20
- Lead Sponsor
- ovartis Pharma AG.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 0
1. Written informed consent must be obtained before any study protocol
specific assessment is performed.
a. 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.
b. Subjects < 18 years old, who are capable of providing
assent, must provide assent with parental/legal guardian
consent or as per local ethical guidelines.
c. 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.
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 :
Subjects who are machine operators or drivers.
Medical history of liver (other than fascioliasis), kidney or cardiac
disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Eevents started after the first dose of study medication or events present prior to start of treatment but increased<br>in severity, will be summarized in the following ways:<br> By primary system organ class and preferred term.<br> By primary system organ class, preferred term and maximum severity.<br>Measure:The number (and percentage) of subjects with treatment emergent adverse events<br>Timepoints:D1- D90<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:•Resolucion de los signos y sintomas iniciales<br>•Mejoria en los parametros de laboratorio iniciales<br>•Mejoria en los hallazgos de la ecografia inicial<br><br>Measure:The clinical cure rate in acute fascioliasis and chronic fascioliasis patients on Day 10, 30, 60<br>and 90<br>Timepoints:Day 10, Day 30, Day 60 and Day<br>90<br>