Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P08034 AM4)



Status:Recruiting
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:3 - 17
Updated:5/27/2013
Start Date:January 2013
End Date:August 2021
Contact:Toll Free Number
Phone:1-888-577-8839

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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


This is a three-part (Part A, Part B, and Part C), open-label, multicenter study of
boceprevir in pediatric participants with chronic hepatitis C (CHC) genotype 1 (GT1). In
Part A and Part B, efficacy and safety will be evaluated in participants with CHC GT1 who
are non-cirrhotic, treatment naïves (Part A) or who are non-cirrhotic, treatment failures to
(peg)interferon/ribavirin or who are cirrhotics (whether treatment naïve or treatment
failure) (Part B). Part C is long-term follow up and no study treatment will be administered
during this period, but participants who do not achieve viral clearance will be allowed to
receive other treatments for CHC.


Inclusion Criteria:

- CHC GT1 infection for at least 6 months with with HCV-RNA ≥10,000 IU/mL.

- Treatment naive, non-cirrhotic participants will be eligible for inclusion in Study
Part A

- Non-cirrhotic subjects who failed previous (peg)interferon/ribavirin treatment for
CHC and cirrhotics, whether treatment naive or treatment failure, will be eligible
for inclusion in Study Part B

- To participate in Study Part C, participants must have completed the required
post-treatment follow-up in Study Part A or Part B

- Weight ≥ 10 kg to ≤ 125 kg

- Body surface area (BSA) ≥0.46 m^2 and ≤2.5 m^2

- Previous liver biopsy with histology consistent with chronic hepatitis C and no other
etiology within 2 years of the screening visit

- Participants with bridging fibrosis or cirrhosis must have an ultrasound within 6
months of the screening visit or between the screening visit and Day 1 with no
findings suspicious for hepatocellular carcinoma

- Participant must be able to adhere to dose and visit schedules

Exclusion Criteria:

- Known co-infection with the the human immunodeficiency virus (HIV) or hepatitis B
virus (HBsAg positive)

- For Study Part A, participant received any prior hepatitis C treatment, including
herbal remedies, with known hepatotoxicity

- For Study Part B, participant received treatment with ribavirin within 90 days or any
interferon alpha within 30 days prior to screening

- For Study Part B, participant received previous treatment with a hepatitis C virus
protease inhibitor (excepting participants in study P07614, Pharmacokinetics of
Boceprevir in Pediatric Subjects With Chronic Hepatitis C Genotype 1)

- For Study Part B, participant required discontinuation of previous
(peg)interferon/ribavirin therapy for an adverse event considered by the investigator
to be related to (peg)interferon and/or ribavirin

- For Study Part B, participant is currently taking any antiviral/immunomodulatory
treatment for hepatitis C

- Participant has taken any investigational drugs, except boceprevir

- Participant has received any of the following medication(s) within 2 weeks prior to
the Day 1 visit: midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine,
and ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine)

- Participation in any other clinical trial within 30 days of enrollment or intent to
participate in another clinical trial during participation in the current study

- Evidence of decompensated liver disease

- Child Pugh score >6 (class B and C)

- History of diabetes or hypertension or was born prior to 32 weeks of gestation and
has clinically significant ocular examination findings

- Pre-existing clinically significant psychiatric condition(s)

- Clinical diagnosis of substance abuse

- Any pre-existing medical condition that could interfere with participation in and
completion of the study

- Evidence of active or suspected malignancy

- Females who are pregnant, nursing, or intend to become pregnant during the study
period

- Allergy or sensitivity to the investigational products or excipients
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