A Study in Pediatric Subjects with Hepatitis C to Study the Effects of Boceprevir and Peginterferon alfa-2b Plus Ribavirin.
- Conditions
- Chronic hepatitis C.MedDRA version: 14.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 100000004862Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2010-024260-17-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 190
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
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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method