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Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for the Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 (P08599)

Primary Purpose

Chronic Hepatitis C

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Boceprevir
Peginterferon Alfa-2b 1.5 mcg/kg/week
Ribavirin
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Weight ≥ 40 kg to ≤ 125 kg
  • Sexually active male participants and female participants of child-bearing potential must agree to use a medically acceptable form of contraception
  • Must have documented Chronic Hepatitis C Genotype 1 infection
  • Must have failed prior treatment with interferon plus ribavirin
  • Must have completed treatment with interferon plus ribavirin for at least 12 weeks
  • Must have had a liver biopsy or Fibroscan to determine status as cirrhotic or non-cirrhotic
  • Participants with cirrhosis must have had an ultrasound or imaging study within 6 months of the Screening visit

Exclusion Criteria:

  • Known co-infection with the human immunodeficiency virus (HIV) or the hepatitis B virus
  • Prior discontinuation of treatment with interferon or ribavirin due to the occurrence of an adverse event(s) considered by the investigator to be possibly or probably related to the treatment
  • Treatment with ribavirin within 90 days and any interferon within 1 month of the Screening visit
  • Treatment with any investigational drug within 30 days prior to the Screening visit
  • Treatment with midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, or ergot derivatives within 2 weeks prior to the Day 1 visit
  • Participation in any investigational trial within 30 days of the Screening visit
  • Evidence of decompensated liver disease
  • Child Pugh score > 6 (Class B and C)
  • Diabetic and/or hypertensive participants with clinically significant ocular examination findings
  • Pre-existing psychiatric conditions
  • Clinical diagnosis of substance abuse
  • Active or suspected malignancy
  • Pregnant or nursing

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Peg2b + Ribavirin + Boceprevir

    Arm Description

    Peginterferon alpha-2b (Peg2b) plus ribavirin (RBV) starting on Day 1 and boceprevir starting on Week 5

    Outcomes

    Primary Outcome Measures

    Percentage of Participants Achieving Sustained Virologic Response (SVR)
    Percentage of Participants Experiencing a Serious Adverse Event (SAE) During the Study Therapy Period

    Secondary Outcome Measures

    Full Information

    First Posted
    July 11, 2012
    Last Updated
    September 7, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01641666
    Brief Title
    Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for the Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 (P08599)
    Official Title
    An Open-Label Study to Assess the Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 Who Failed Prior Treatment With Any Interferon Plus Ribavirin in Vietnam
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    September 2016 (Anticipated)
    Study Completion Date
    September 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is designed to assess the safety and tolerability of boceprevir dosed 800 mg three times daily (TID) orally (PO) in combination with Peginterferon alfa-2b (PEG2b) 1.5 mcg/kg once a week (QW) administered subcutaneously (SC) plus ribavirin (RBV) (800 to 1400 mg/day) PO in Response Guided Therapy (RGT) in adult Vietnamese subjects with Chronic Hepatitis C, Genotype 1 (CHC GT1) who failed prior treatment with any interferon and ribavirin in Vietnam.
    Detailed Description
    Each participant will participate in the trial for a maximum of 80 weeks from the time the participant signs the Informed Consent Form (ICF) through the final contact. After a Screening phase of approximately 4 to 8 weeks, each participant will receive treatment for approximately 36-48 weeks depending on response at Treatment Week 8. A 4-week lead-in period with PEG2b plus RBV will be followed by 32 weeks boceprevir plus PEG2b/RBV. At treatment Week 36 participants will be assigned to the following treatments depending on the virologic response at Week 8 and cirrhotic status: For non-cirrhotic participants with undetectable hepatitis C virus (HCV)-RNA on Week 8, all treatment will be discontinued at Week 36. For non-cirrhotic participants with detectable HCV-RNA on Week 8, only boceprevir treatment will be discontinued at Week 36 and PEG2b and RBV treatment will continue to Week 48. For cirrhotic participants, the boceprevir plus PEG2b/RBV treatment will continue to Week 48. The study has a futility rule at Week 12 at which point all subjects with detectable HCV-RNA levels will be discontinued. All participants will have a post-treatment follow-up period of at least 24 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Hepatitis C

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Peg2b + Ribavirin + Boceprevir
    Arm Type
    Experimental
    Arm Description
    Peginterferon alpha-2b (Peg2b) plus ribavirin (RBV) starting on Day 1 and boceprevir starting on Week 5
    Intervention Type
    Drug
    Intervention Name(s)
    Boceprevir
    Other Intervention Name(s)
    SCH 503034
    Intervention Description
    Boceprevir will be dosed orally at a dose of 800 mg three times daily (TID) for a total daily dose of 2400 mg.
    Intervention Type
    Drug
    Intervention Name(s)
    Peginterferon Alfa-2b 1.5 mcg/kg/week
    Other Intervention Name(s)
    Pegintron®, Rebetol®
    Intervention Description
    Peginterferon alpha-2b will be administered subcutaneously at a dose of 1.5 mcg/kg each week.
    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin
    Other Intervention Name(s)
    Rebetol®, Pegintron®
    Intervention Description
    Ribavirin will be administered orally at a dose of 800 mg/day to 1400 mg/day in two divided daily doses (BID).
    Primary Outcome Measure Information:
    Title
    Percentage of Participants Achieving Sustained Virologic Response (SVR)
    Time Frame
    Follow-Up Week 24
    Title
    Percentage of Participants Experiencing a Serious Adverse Event (SAE) During the Study Therapy Period
    Time Frame
    Treatment Week 1 to Treatment Week 24

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Weight ≥ 40 kg to ≤ 125 kg Sexually active male participants and female participants of child-bearing potential must agree to use a medically acceptable form of contraception Must have documented Chronic Hepatitis C Genotype 1 infection Must have failed prior treatment with interferon plus ribavirin Must have completed treatment with interferon plus ribavirin for at least 12 weeks Must have had a liver biopsy or Fibroscan to determine status as cirrhotic or non-cirrhotic Participants with cirrhosis must have had an ultrasound or imaging study within 6 months of the Screening visit Exclusion Criteria: Known co-infection with the human immunodeficiency virus (HIV) or the hepatitis B virus Prior discontinuation of treatment with interferon or ribavirin due to the occurrence of an adverse event(s) considered by the investigator to be possibly or probably related to the treatment Treatment with ribavirin within 90 days and any interferon within 1 month of the Screening visit Treatment with any investigational drug within 30 days prior to the Screening visit Treatment with midazolam, pimozide, amiodarone, flecainide, propafenone, quinidine, or ergot derivatives within 2 weeks prior to the Day 1 visit Participation in any investigational trial within 30 days of the Screening visit Evidence of decompensated liver disease Child Pugh score > 6 (Class B and C) Diabetic and/or hypertensive participants with clinically significant ocular examination findings Pre-existing psychiatric conditions Clinical diagnosis of substance abuse Active or suspected malignancy Pregnant or nursing

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Tolerability of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin for the Treatment of Vietnamese Subjects With Chronic Hepatitis C Genotype 1 (P08599)

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