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

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注册库

who.int

开始日期

2012年8月23日

结束日期

待定

最后更新

8年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

•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\).
•KEY LABORATORY EXCLUSION CRITERIA:
•1\.Hemoglobin is not within normal limits of the laboratory reference range for the subject's age
•2\.Neutrophils \<1500/mm3