Assessment of the Safety, Efficacy, Tolerability and Pharmacokinetics of PEG-Intron Plus REBETOL for Pediatric Patients with Chronic Hepatitis C

Schering-Plough Research Insitute0 sites107 target enrollmentDecember 9, 2005

Overview

No summary available.

Registry

who.int

Start Date

December 9, 2005

End Date

January 10, 2013

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Schering-Plough Research Insitute

•\-History of chronic hepatitis C as documented either by anti\-HCV or HCV RNA
•positivity at least 6 months prior to Screening 1\.
•\-Subjects 3 through 17 years of age (inclusive) at time of Screening 2, of either
•\-Plasma positive for HCV RNA by quantitative RT\-PCR, as measured by the
•sponsor's assay, during Screening 1 visit.
•\-Results of a liver biopsy performed prior to entry to the study are required
•(except as noted below):
•Patients who have had a liver biopsy performed prior to consideration for
•the study (historical liver biopsy) must have the pathology report confirming that the histological diagnosis is consistent with chronic hepatitis (evidence of fibrosis and/or
•inflammatory activity) and slides from this biopsy must be available

•All subjects will be excluded from entry if any of the criteria listed below are
•\-Serum ALT level \>10 times the upper limit of normal within the 6 months prior
•to Screening 1 visit.
•\-Any other cause for liver disease other than chronic hepatitis C.
•\-Evidence of decompensated liver disease.
•\-The most recent liver biopsy is normal.
•\-Prior treatment for chronic hepatitis C.
•\-Known coinfection with either HIV or HBV.
•\-Known immunodeficiency disorders requiring immunoglobulin therapy.
•\-Known coagulopathies, including hemophilia, or anticoagulant use.