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Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059) (START 4)

Primary Purpose

Hepatitis C, Chronic

Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
PEG-IFN alfa-2b
ribavirin
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, Chronic

Eligibility Criteria

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

Inclusion Criteria:

  • Participant is ≥40 kg and ≤120 kg weight
  • Participant and participant's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations.
  • Previously documented CHC genotype 4 infection
  • Liver biopsy or fibrotest and fibroscan with histology consistent with CHC and no other etiology and with hepatic fibrosis scores (F0, F1, F2, F3).

Exclusion Criteria:

  • Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus
  • Treatment for hepatitis C with any investigational medication
  • Treatment with any investigational drug 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
  • Autoimmune hepatitis or a history of autoimmune disease
  • Hepatic fibrosis score F4
  • Severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months
  • Autoimmune hepatitis or a history of autoimmune disease
  • Thyroid disease uncontrolled with conventional treatment
  • Epilepsy and/or compromised central nervous system (CNS) function

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    44 Weeks of PEG-IFN alfa-2b + RBV

    20 Weeks of PEG-IFN alfa-2b + RBV

    Arm Description

    Participants achieving RVR at 4 weeks of treatment will receive 44 additional weeks of Peg-IFN Alfa-2b + RBV.

    Participants achieving RVR at 4 weeks of treatment will receive 20 additional weeks of Peg-IFN Alfa-2b + RBV.

    Outcomes

    Primary Outcome Measures

    Number of Participants Achieving Sustained Virologic Response (SVR)
    SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 24, 2012
    Last Updated
    September 27, 2018
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01606800
    Brief Title
    Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059)
    Acronym
    START 4
    Official Title
    Randomized Open Label Study to Assess the Efficacy and Safety of Short Course Therapy (24 Weeks) With Peginterferon Alpha-2b and Ribavirin for Chronic Hepatitis C (Genotype 4) Patients Who Achieve a Rapid Virological Response (HCV -RNA Undetectable at Week 4 of Treatment)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2018
    Overall Recruitment Status
    Terminated
    Why Stopped
    The trial was terminated due to change in new standard of therapy during the study period.
    Study Start Date
    January 1, 2013 (Actual)
    Primary Completion Date
    January 26, 2015 (Actual)
    Study Completion Date
    January 26, 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
    The purpose of this study is to assess the efficacy of a short course of therapy (24 weeks) versus standard 48 week treatment in previously untreated adult participants with chronic hepatitis C (CHC) genotype 4 infection who achieve rapid virologic response (RVR), defined as HCV ribonucleic acid (RNA) negativity after 4 weeks of treatment.
    Detailed Description
    Participants who achieved RVR after 4 weeks of PEG-INF alfa-2b plus RBV treatment were randomized to receive either 20 or 44 weeks of continued therapy, for a total of 24 or 48 weeks total of PEG-INF plus RBV therapy.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    44 Weeks of PEG-IFN alfa-2b + RBV
    Arm Type
    Experimental
    Arm Description
    Participants achieving RVR at 4 weeks of treatment will receive 44 additional weeks of Peg-IFN Alfa-2b + RBV.
    Arm Title
    20 Weeks of PEG-IFN alfa-2b + RBV
    Arm Type
    Experimental
    Arm Description
    Participants achieving RVR at 4 weeks of treatment will receive 20 additional weeks of Peg-IFN Alfa-2b + RBV.
    Intervention Type
    Drug
    Intervention Name(s)
    PEG-IFN alfa-2b
    Intervention Description
    Pegylated interferon alfa-2b administered subcutaneously 1.5 mcg/kg/week
    Intervention Type
    Drug
    Intervention Name(s)
    ribavirin
    Intervention Description
    Ribavirin 200 mg capsules administered orally daily based on weight
    Primary Outcome Measure Information:
    Title
    Number of Participants Achieving Sustained Virologic Response (SVR)
    Description
    SVR was defined as undetectable HCV RNA levels 24 weeks after the completion of therapy.
    Time Frame
    At 24 weeks after the completion of therapy (up to 72 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Participant is ≥40 kg and ≤120 kg weight Participant and participant's partner(s) must each agree to use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations. Previously documented CHC genotype 4 infection Liver biopsy or fibrotest and fibroscan with histology consistent with CHC and no other etiology and with hepatic fibrosis scores (F0, F1, F2, F3). Exclusion Criteria: Co-infected with the human immunodeficiency virus (HIV) or hepatitis B virus Treatment for hepatitis C with any investigational medication Treatment with any investigational drug 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 Autoimmune hepatitis or a history of autoimmune disease Hepatic fibrosis score F4 Severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous six months Autoimmune hepatitis or a history of autoimmune disease Thyroid disease uncontrolled with conventional treatment Epilepsy and/or compromised central nervous system (CNS) function
    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
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/study.html?id=8908B-059&kw=8908B-059&tab=access

    Learn more about this trial

    Efficacy and Safety of Short Course Therapy With Peginterferon Alpha-2b (PEG-IFN Alfa-2b) and Ribavirin (RBV) for Chronic Hepatitis C (Genotype 4) Participants Achieving a Rapid Virological Response at Week 4 of Treatment (MK-8908B-059)

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