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

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 190

Inclusion Criteria

1. Age > or = to 3 years and <18 years on the day of initiation of treatment (Day 1).
2. Weight > or = to 10 kg and < or = to 125 kg.
3. Body surface area (BSA) > or = to 0.46 m2 and < or = to 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. 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 posttreatment 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 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
3. Platelets <100,000/mm3
4. Direct bilirubin >1.5 x upper limit of normal (ULN) of the laboratory reference range. Total bilirubin >1.6 mg/dL, unless the subject has a history of Gilbert's disease. If Gilbert's disease is the proposed etiology, this must be documented.
5. Serum albumin 6. Thyroid-stimulating hormone (TSH) >1.2 x ULN or <0.8 x LLN of laboratory reference range with the following exceptions:
a. The subject may be enrolled if clinically euthyroid, b. The euthyroid
function is confirmed by thyroxine (T4) testing.
7.Serum creatinine >ULN of laboratory reference range.
8. Serum glucose:
a. For subjects not previously diagnosed with non-insulin dependent
diabetes: ?140 mg/dL (nonfasting) unless hemoglobin A1c subtype
(HbA1c) ?7%.
b. For subjects previously diagnosed with non-insulin dependent
diabetes: HbA1c >8.5%.
9.Prothrombin time (PT) values >10% above laboratory reference range.
10.Alpha fetoprotein (AFP) for subjects with cirrhosis only:
a. AFP >100 ng/mL OR
b. AFP is between 50 ng/mL to 100 ng/mL, a liver ultrasound is required. Subjects with findings suspicious for hepatocellular carcinoma will be excluded.

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

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