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

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

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).
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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