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A Study of Viral Response to Triple Therapy in Hepatitis C Virus-Infected Participants With Insulin Resistance Who Failed Dual Therapy (MK-3034-113)

Primary Purpose

Hepatitis C

Status
Withdrawn
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 - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Quantifiable serum hepatitis C virus-ribonucleic acid (HCV-RNA)
  • Hepatitis C virus genotype 1
  • Homeostasis Model of Assessment - Insulin Resistance (HOMA IR) > 2.5 in two determinations made 4 weeks apart (the first HOMA evaluation is able to be made 3 weeks before screening visit)
  • Previous failure to achieve SVR with PegIFN plus ribavirin given for a minimum of 12 weeks without dose reduction below 80% of the adequate doses of the two drugs
  • No response, partial response, or relapse after previous therapy
  • Compensated liver disease with or without histologic or non-invasive evidence of liver cirrhosis
  • If heterosexually active, a female participant of childbearing potential and a non-vasectomized male participant who has a female partner of childbearing potential must agree to use 2 effective contraceptives until 6 months after therapy has ended (7 months for male subject)

Exclusion criteria:

  • Coinfection with HCV genotypes other than HCV-GT1
  • Evidence of decompensated liver disease
  • History of ascites, hepatic encephalopathy or of bleeding varices or severe portal hypertension
  • History or signs or symptoms or evidence of hepatocellular carcinoma (HCC)
  • History of organ transplant
  • Coinfection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Severe psychiatric disease
  • Inadequately controlled thyroid function
  • Other important comorbidities (cardiovascular diseases, Type 1 diabetes or inadequately controlled type 2 diabetes, malignancies , etc)
  • Substances abuse
  • Alcohol intake >20 grams/day for females and >30 grams/day for males
  • History of severe adverse events during previous treatment with PegIFN plus ribavirin including discontinuation of therapy for severe anemia or hematologic toxicity

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Boceprevir + PegIFN-2b + RBV

    Arm Description

    All participants will start treatment with 4 weeks of PegIFN-2b subcutaneously, 1.5μg/kg per week + RBV capsules orally, at a weight-based dose between 800-1400 mg/day divided into two daily doses (double therapy). Participants without cirrhosis will then continue on the PegIFN-2b and RBV with the addition of boceprevir capsules orally, 800 mg three times per day for 32 weeks (triple therapy), and will transition back to double therapy for the final 12 weeks of treatment (48 total weeks of therapy). Participants with cirrhosis or documented as null responders will receive triple therapy for 44 weeks (48 total weeks of therapy).

    Outcomes

    Primary Outcome Measures

    Number of participants with sustained virologic response (SVR) at 24 weeks after the end of 48 weeks of study treatment

    Secondary Outcome Measures

    Change from baseline in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)

    Full Information

    First Posted
    January 15, 2013
    Last Updated
    March 17, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01770223
    Brief Title
    A Study of Viral Response to Triple Therapy in Hepatitis C Virus-Infected Participants With Insulin Resistance Who Failed Dual Therapy (MK-3034-113)
    Official Title
    An Open Label Study Assessing SVR and Viral Resistance Profile With Boceprevir Plus PEG-IFN Plus Ribavirin Triple Therapy in HCV-1 Infected Patients With Insulin Resistance Who Have Failed PEG-IFN Plus Ribavirin Dual Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    January 2014 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    December 2015 (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 being done to find out if participants with insulin resistance and hepatitis C virus genotype 1 (HCV GT1) infections who failed dual therapy with peginterferon alfa (PegIFN) + ribavirin (RBV) will benefit from the addition of boceprevir to PegIFN + RBV (triple therapy).

    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
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Boceprevir + PegIFN-2b + RBV
    Arm Type
    Experimental
    Arm Description
    All participants will start treatment with 4 weeks of PegIFN-2b subcutaneously, 1.5μg/kg per week + RBV capsules orally, at a weight-based dose between 800-1400 mg/day divided into two daily doses (double therapy). Participants without cirrhosis will then continue on the PegIFN-2b and RBV with the addition of boceprevir capsules orally, 800 mg three times per day for 32 weeks (triple therapy), and will transition back to double therapy for the final 12 weeks of treatment (48 total weeks of therapy). Participants with cirrhosis or documented as null responders will receive triple therapy for 44 weeks (48 total weeks of therapy).
    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
    Number of participants with sustained virologic response (SVR) at 24 weeks after the end of 48 weeks of study treatment
    Time Frame
    Week 72
    Secondary Outcome Measure Information:
    Title
    Change from baseline in Homeostasis Model of Assessment - Insulin Resistance (HOMA-IR)
    Time Frame
    Baseline up to 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Quantifiable serum hepatitis C virus-ribonucleic acid (HCV-RNA) Hepatitis C virus genotype 1 Homeostasis Model of Assessment - Insulin Resistance (HOMA IR) > 2.5 in two determinations made 4 weeks apart (the first HOMA evaluation is able to be made 3 weeks before screening visit) Previous failure to achieve SVR with PegIFN plus ribavirin given for a minimum of 12 weeks without dose reduction below 80% of the adequate doses of the two drugs No response, partial response, or relapse after previous therapy Compensated liver disease with or without histologic or non-invasive evidence of liver cirrhosis If heterosexually active, a female participant of childbearing potential and a non-vasectomized male participant who has a female partner of childbearing potential must agree to use 2 effective contraceptives until 6 months after therapy has ended (7 months for male subject) Exclusion criteria: Coinfection with HCV genotypes other than HCV-GT1 Evidence of decompensated liver disease History of ascites, hepatic encephalopathy or of bleeding varices or severe portal hypertension History or signs or symptoms or evidence of hepatocellular carcinoma (HCC) History of organ transplant Coinfection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) Severe psychiatric disease Inadequately controlled thyroid function Other important comorbidities (cardiovascular diseases, Type 1 diabetes or inadequately controlled type 2 diabetes, malignancies , etc) Substances abuse Alcohol intake >20 grams/day for females and >30 grams/day for males History of severe adverse events during previous treatment with PegIFN plus ribavirin including discontinuation of therapy for severe anemia or hematologic toxicity

    12. IPD Sharing Statement

    Learn more about this trial

    A Study of Viral Response to Triple Therapy in Hepatitis C Virus-Infected Participants With Insulin Resistance Who Failed Dual Therapy (MK-3034-113)

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