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A Study to Evaluate the Efficacy and Safety of Boceprevir Added to Standard of Care Therapy in Previously Treated Participants With Chronic Hepatitis C Genotype 1 and Cirrhosis (MK-3034-105)

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
boceprevir
PegIFN-2b
RBV
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Weight between 40 kg and 125 kg
  • Documented CHC genotype 1 infection
  • Previous course of treatment with SOC (PegIFN-2a or PegIFN-2b + RBV) with a documented non-response
  • Documented diagnosis of cirrhosis
  • No evidence of hepatocellular carcinoma (HCC) by ultrasound
  • Participant and partner of participant must agree to use 2 effective contraceptives as specified for at least 2 weeks prior to Day 1 of treatment and continue until at least 6 months after last dose of study drug (7 months for male participants)

Exclusion criteria:

  • Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus
  • Use of any investigational drugs within 30 days prior to study enrollment
  • Participation in any other clinical trial within 30 days of study enrollment or intention to participate in another clinical trial during this study
  • Evidence of present or previous decompensated liver disease including, but not limited to, a history or presence of clinical ascites or hepatic encephalopathy. Only participants with large (F3) esophageal varices, as determined in an esophagogastroduodenoscopy (EGD) performed within the past 12 months according to international guidelines will be excluded.
  • Clinically significant ocular examination findings
  • Pre-existing significant psychiatric condition(s)
  • Clinical diagnosis of active or recent substance abuse
  • Evidence of active or suspected malignancy, or a history of malignancy, within the last 3 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PegIFN-2b + RBV+ boceprevir

    Arm Description

    Participants will receive PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks and then will receive 44 additional weeks of treatment with PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day).

    Outcomes

    Primary Outcome Measures

    Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24)
    Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using a polymerase chain reaction assay. SVR24 was defined as HCV RNA less than the Limit of Quantification (<25 International Units (IU)/mL) 24 weeks after the end of the Treatment Period.
    Percentage of Participants With One or More Adverse Events
    Adverse events were monitored during the Lead-in and Treatment Periods
    Percentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication
    Adverse events were monitored during the Lead-in and Treatment Periods

    Secondary Outcome Measures

    Full Information

    First Posted
    December 19, 2012
    Last Updated
    August 6, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01756079
    Brief Title
    A Study to Evaluate the Efficacy and Safety of Boceprevir Added to Standard of Care Therapy in Previously Treated Participants With Chronic Hepatitis C Genotype 1 and Cirrhosis (MK-3034-105)
    Official Title
    A Multi-centre Single-arm Study to Evaluate the Efficacy and Safety of BOCEPREVIR 44 Weeks in Addition to Standard of Care (SOC) in Previously Treatment Failure (Relapser, Non-responders, Both Partial and Null) Patients With Chronic Hepatitis C Genotype 1 (G1) and Cirrhosis (F4 Metavir). (MK-3034-105)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    February 6, 2013 (Actual)
    Primary Completion Date
    November 17, 2015 (Actual)
    Study Completion Date
    November 17, 2015 (Actual)

    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 being done to find out if the addition of boceprevir to standard of care (SOC) treatment with peginterferon alfa-2b (PegIFN-2b) + ribavirin (RBV) is effective for participants with chronic hepatitis C (CHC) genotype 1 and cirrhosis who were not successfully treated by previous SOC. All participants will receive treatment with SOC alone for 4 weeks and then boceprevir will be added to the treatment regimen for 44 additional weeks of combined treatment.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    58 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PegIFN-2b + RBV+ boceprevir
    Arm Type
    Experimental
    Arm Description
    Participants will receive PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks and then will receive 44 additional weeks of treatment with PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day).
    Intervention Type
    Drug
    Intervention Name(s)
    boceprevir
    Other Intervention Name(s)
    SCH 503034
    Intervention Type
    Biological
    Intervention Name(s)
    PegIFN-2b
    Other Intervention Name(s)
    Peginterferon alfa-2b, PegIntron, SCH 054031
    Intervention Type
    Drug
    Intervention Name(s)
    RBV
    Other Intervention Name(s)
    Ribavirin, Rebetol
    Primary Outcome Measure Information:
    Title
    Percentage of Participants Who Achieve Sustained Virological Response at Follow-up Week 24 (SVR24)
    Description
    Hepatitis C Virus (HCV) ribonucleic acid (RNA) was measured using a polymerase chain reaction assay. SVR24 was defined as HCV RNA less than the Limit of Quantification (<25 International Units (IU)/mL) 24 weeks after the end of the Treatment Period.
    Time Frame
    Week 72 (24 weeks after end of treatment)
    Title
    Percentage of Participants With One or More Adverse Events
    Description
    Adverse events were monitored during the Lead-in and Treatment Periods
    Time Frame
    Up to 48 weeks (Lead-in and Treatment Periods)
    Title
    Percentage of Participants With an Adverse Event Leading to Discontinuation of Study Medication
    Description
    Adverse events were monitored during the Lead-in and Treatment Periods
    Time Frame
    Up to 48 weeks (Lead-in and Treatment Periods)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Weight between 40 kg and 125 kg Documented CHC genotype 1 infection Previous course of treatment with SOC (PegIFN-2a or PegIFN-2b + RBV) with a documented non-response Documented diagnosis of cirrhosis No evidence of hepatocellular carcinoma (HCC) by ultrasound Participant and partner of participant must agree to use 2 effective contraceptives as specified for at least 2 weeks prior to Day 1 of treatment and continue until at least 6 months after last dose of study drug (7 months for male participants) Exclusion criteria: Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus Use of any investigational drugs within 30 days prior to study enrollment Participation in any other clinical trial within 30 days of study enrollment or intention to participate in another clinical trial during this study Evidence of present or previous decompensated liver disease including, but not limited to, a history or presence of clinical ascites or hepatic encephalopathy. Only participants with large (F3) esophageal varices, as determined in an esophagogastroduodenoscopy (EGD) performed within the past 12 months according to international guidelines will be excluded. Clinically significant ocular examination findings Pre-existing significant psychiatric condition(s) Clinical diagnosis of active or recent substance abuse Evidence of active or suspected malignancy, or a history of malignancy, within the last 3 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Director
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
    IPD Sharing URL
    http://engagezone.msd.com/ds_documentation.php

    Learn more about this trial

    A Study to Evaluate the Efficacy and Safety of Boceprevir Added to Standard of Care Therapy in Previously Treated Participants With Chronic Hepatitis C Genotype 1 and Cirrhosis (MK-3034-105)

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