A Study in Pediatric Subjects with Hepatitis C to Study the Effects of Boceprevir and Peginterferon alfa-2b Plus Ribaviri

• Conditions: Chronic Hepatitis C; MedDRA version: 14.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2010-024260-17-DE
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-14
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

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,
OR
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
Number of subjects for this age range: 190
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified