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: July 18, 2014
Last verified: July 2014

July 7, 2011
July 18, 2014
October 2011
February 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01390844 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hepatitis C, Chronic
  • 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
  • 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
  • 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.
    Interventions:
    • Drug: Boceprevir (BOC)
    • Drug: Placebo to boceprevir
    • Drug: Peginterferon alfa-2b (PEG)
    • Drug: Ribavirin (RBV)
  • 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.
    Interventions:
    • Drug: Placebo to boceprevir
    • Drug: Peginterferon alfa-2b (PEG)
    • Drug: Ribavirin (RBV)
    • Drug: Cross-Over Boceprevir Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
270
February 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01390844
P07063, 2007-005151-42, 3034-033, CTRI/2012/04/002540
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP