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: August 1, 2014
Last verified: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 1, 2014
Health Authority: India: Drugs Controller General of India

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014