A Phase 3 Study to Assess the Efficacy and Safety of Boceprevir in Combination with Peginterferon alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 - A Study in Pediatric Subjects with Hepatitis C to Study the Effects of Boc/ Peg/ Riba

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc0 sites190 target enrollmentAugust 14, 2012

Overview

No summary available.

Registry

who.int

Start Date

August 14, 2012

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc

•1\. Age \=3 years and \<18 years on the day of initiation of treatment (Day 1\).
•2\. Weight \=10 kg and \=125 kg.
•3\. Body surface area (BSA) \=0\.46 m2 and \=2\.5 m2\.
•4\. Each subject must have a liver biopsy with histology consistent with CHC and no other etiology within 2 years of the screening visit. If a previous liver biopsy is not available, the liver biopsy may be obtained during the screening period. The pathology report must be available at the study site.
•5\. Part A: Treatment naïve, non\-cirrhotic pediatric subject with CHC genotype 1 (mixed genotypes are not eligible).
•6\. Part B: Pediatric subject with CHC genotype 1 (mixed genotypes are not eligible) who:
•a) failed previous (peg)interferon/RBV treatment (null responder, partial responder, relapser, or other”) and is non\-cirrhotic,
•b) is cirrhotic regardless of whether treatment naïve or a treatment failure.
•7\. Part C: Subject must have completed the required post\-treatment follow\-up in Part A or Part B.
•Are the trial subjects under 18? yes

•1\. Subject is known to be co\-infected with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive).
•2\. Subject exhibits evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy.
•3\. Part A: Subject received any prior hepatitis C treatment, including herbal remedies with known hepatotoxicity but excluding study treatment received in the boceprevir pediatric Phase 1 single dose PK study (P07614\).
•4\. Part B: Subject received treatment with RBV within 90 days or any (peg)interferon within 30 days prior to screening.
•5\. Part B: Subject received previous treatment with a HCV protease inhibitor but excluding study treatment received in the boceprevir pediatric Phase 1 single dose PK study (P07614\).
•6\. Part B: Subject required discontinuation of previous (peg)interferon/RBV therapy for an AE considered by the investigator to be related to (peg)interferon and/or RBV.
•7\. Part B: Subject is currently taking any antiviral/immunomodulatory treatment for HCV but excluding study treatment received in the boceprevir pediatric Phase 1 single dose PK study (P07614\).