Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01390844
First received: July 7, 2011
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

This study will assess the efficacy of boceprevir (BOC) in combination with PegIntron (pegylated interferon alfa-2b) (PEG) and ribavirin (RBV) in response guided therapy compared to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis C (CHC) genotype 1 who failed prior treatment with pegylated interferon and RBV in the Asia Pacific population.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Boceprevir (BOC)
Drug: Placebo to boceprevir
Drug: Peginterferon alfa-2b (PEG)
Drug: Ribavirin (RBV)
Drug: Cross-Over Boceprevir Treatment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Boceprevir in Combination With Peginterferon Plus Ribavirin for Treatment of Asia Pacific Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Pegylated Interferon Plus Ribavirin (Protocol No. P07063)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Sustained virologic response, defined as undetectable plasma hepatitis C virus ribonucleic acid (HCV-RNA) at Follow-up Week 24 in participants who received at least one dose of any trial medication (i.e. PEG, RBV, BOC, or placebo) [ Time Frame: Follow-up Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sustained virologic response, defined as undetectable plasma HCV-RNA at Follow-up Week 24 in participants who received at least one dose of experimental trial medication (i.e. placebo or BOC) [ Time Frame: Follow-up Week 24 ] [ Designated as safety issue: No ]
  • Number of participants achieving early virologic response (undetectable HCV-RNA at Treatment Week 8) [ Time Frame: Treatment Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 270
Study Start Date: October 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Boceprevir
PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
Drug: Boceprevir (BOC)
200 mg capsules, 800 mg three times daily by mouth
Other Name: SCH 503034, Victrelis
Drug: Placebo to boceprevir
200 mg placebo capsules, 800 mg three times daily by mouth
Drug: Peginterferon alfa-2b (PEG)
1.5 mcg/kg/week subcutaneously
Other Name: PegIntron, SCH 054031
Drug: Ribavirin (RBV)
200 mg capsules, weight-based dosing 800 to 1400 mg/day by mouth divided twice daily
Other Name: Rebetol, SCH 018908
Active Comparator: Control
PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
Drug: Placebo to boceprevir
200 mg placebo capsules, 800 mg three times daily by mouth
Drug: Peginterferon alfa-2b (PEG)
1.5 mcg/kg/week subcutaneously
Other Name: PegIntron, SCH 054031
Drug: Ribavirin (RBV)
200 mg capsules, weight-based dosing 800 to 1400 mg/day by mouth divided twice daily
Other Name: Rebetol, SCH 018908
Drug: Cross-Over Boceprevir Treatment
At Treatment Week 14, participants in the Placebo group with detectable HCV-RNA at Treatment Week 12 have the option to add boceprevir 800 mg three times daily to the PEG + RBV regimen for up to 32 weeks.
Other Name: SCH 503034, Victrelis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously documented CHC genotype 1 infection. Other or mixed genotypes are not eligible.
  • Liver biopsy with histology consistent with CHC and no other etiology.
  • Participants with cirrhosis must have an ultrasound/imaging study within 6 months of screening (or between screening and Day 1) with no findings suspicious for hepatocellular carcinoma
  • Failed previous treatment (of at least 12 weeks) with pegylated interferon (alfa-2a or alfa-2b) plus RBV
  • Weight between 40 kg and 125 kg, inclusive
  • Of 'local' ancestral descent
  • Sexually active males and females of child-bearing potential must agree to use a medically accepted method of contraception

Exclusion Criteria:

  • Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus
  • Required discontinuation of previous interferon or RBV regimen for an adverse event considered to be possibly or probably related to RBV and/or interferon
  • Treatment with RBV within 90 days and any interferon-alpha within 1 month prior to screening
  • Treatment for hepatitis C with any investigational medication or prior treatment with herbal remedies with known hepatotoxicity
  • Treatment with any investigational drug or participation in any interventional clinical trial within 30 days of the screening visit
  • Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
  • Diabetes and/or hypertension with clinically significant ocular examination findings
  • Any condition the could interfere with participation in and completion of the trial
  • Evidence of active or suspected malignancy, or history of malignancy within the last 5 years (except adequately treatment carcinoma in situ and basal cell carcinoma of the skin)
  • Pregnant or breast-feeding
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01390844     History of Changes
Other Study ID Numbers: P07063, 2007-005151-42, 3034-033, CTRI/2012/04/002540
Study First Received: July 7, 2011
Last Updated: January 21, 2014
Health Authority: India: Drugs Controller General of India

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 14, 2014