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Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005)

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
IDX184
Peginterferon alfa-2a (Peg-IFN)
Ribavirin (RBV)
Placebo
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 focused on measuring Hepatitis C, HCV, treatment-naive

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and females with documented genotype 1, chronic hepatitis C infection.
  • Must agree to use double-barrier method of birth control for at least 6 months after the last dose of study drugs.
  • Has not received prior antiviral treatment for HCV.
  • Written informed consent by participant.

Exclusion Criteria:

  • Pregnant or breastfeeding.
  • Co-infected with hepatitis B virus (HBV; hepatitis B surface antigen [HBsAg] positive) and/or human immunodeficiency virus (HIV).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    IDX184 50 mg + Peg-IFN/RBV

    IDX184 100 mg + Peg-IFN/RBV

    Arm Description

    IDX184 50 mg and matching placebo once daily plus peginterferon alfa-2a (Peg-IFN) weekly and ribavirin (RBV) daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks.

    IDX184 100 mg once daily plus Peg-IFN weekly and RBV daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks.

    Outcomes

    Primary Outcome Measures

    Percentage of participants who experience a serious adverse event
    Percentage of participants who experience an adverse event
    Percentage of participants who experience a grade 1-4 laboratory abnormality
    Percentage of participants who achieve undetectable HCV ribonucleic acid (RNA) viral levels at Week 12

    Secondary Outcome Measures

    Percentage of participants who achieve undetectable HCV RNA viral levels at Week 4
    Percentage of participants who achieve undetectable HCV RNA viral levels at the end of treatment
    Percentage of participants who achieve sustained virologic response (SVR)
    Percentage of participants who achieve HCV RNA viral levels below the lower level of quantification (LLOQ) at Week 4
    Percentage of participants who achieve HCV RNA viral levels below LLOQ at the end of treatment
    Percentage of participants who achieve HCV RNA viral levels below LLOQ at follow-up (24 weeks after the last dose)

    Full Information

    First Posted
    June 9, 2011
    Last Updated
    February 5, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01371604
    Brief Title
    Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005)
    Official Title
    A Randomized, Double-Blind Study to Evaluate the Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2011 (undefined)
    Primary Completion Date
    March 2013 (Actual)
    Study Completion Date
    October 2014 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the safety and antiviral activity of IDX184 in combination with pegylated interferon and ribavirin in treatment-naïve subjects with genotype 1 chronic hepatitis C virus (HCV) infection.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatitis C, Chronic
    Keywords
    Hepatitis C, HCV, treatment-naive

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    68 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IDX184 50 mg + Peg-IFN/RBV
    Arm Type
    Experimental
    Arm Description
    IDX184 50 mg and matching placebo once daily plus peginterferon alfa-2a (Peg-IFN) weekly and ribavirin (RBV) daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks.
    Arm Title
    IDX184 100 mg + Peg-IFN/RBV
    Arm Type
    Experimental
    Arm Description
    IDX184 100 mg once daily plus Peg-IFN weekly and RBV daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    IDX184
    Intervention Description
    IDX184 50 mg tablet administered orally
    Intervention Type
    Biological
    Intervention Name(s)
    Peginterferon alfa-2a (Peg-IFN)
    Other Intervention Name(s)
    Pegasys
    Intervention Description
    Peginterferon alfa-2 180 microgram prefilled syringe administered subcutaneously once weekly
    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin (RBV)
    Intervention Description
    Ribavirin 200 mg tablets administered orally as a divided dose twice daily. Total daily dose to administered will be 1000 or 1200 mg based on body weight.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Matching placebo to IDX184 50 mg tablet administered orally
    Primary Outcome Measure Information:
    Title
    Percentage of participants who experience a serious adverse event
    Time Frame
    Up to Week 16 and end of treatment (Weeks 24 or 48)
    Title
    Percentage of participants who experience an adverse event
    Time Frame
    16 weeks
    Title
    Percentage of participants who experience a grade 1-4 laboratory abnormality
    Time Frame
    16 weeks
    Title
    Percentage of participants who achieve undetectable HCV ribonucleic acid (RNA) viral levels at Week 12
    Time Frame
    Week 12
    Secondary Outcome Measure Information:
    Title
    Percentage of participants who achieve undetectable HCV RNA viral levels at Week 4
    Time Frame
    Week 4
    Title
    Percentage of participants who achieve undetectable HCV RNA viral levels at the end of treatment
    Time Frame
    Weeks 24 or 48
    Title
    Percentage of participants who achieve sustained virologic response (SVR)
    Time Frame
    24 weeks after the last dose (Weeks 48 or 72)
    Title
    Percentage of participants who achieve HCV RNA viral levels below the lower level of quantification (LLOQ) at Week 4
    Time Frame
    Week 4
    Title
    Percentage of participants who achieve HCV RNA viral levels below LLOQ at the end of treatment
    Time Frame
    Weeks 24 or 48
    Title
    Percentage of participants who achieve HCV RNA viral levels below LLOQ at follow-up (24 weeks after the last dose)
    Time Frame
    Weeks 48 or 72

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Males and females with documented genotype 1, chronic hepatitis C infection. Must agree to use double-barrier method of birth control for at least 6 months after the last dose of study drugs. Has not received prior antiviral treatment for HCV. Written informed consent by participant. Exclusion Criteria: Pregnant or breastfeeding. Co-infected with hepatitis B virus (HBV; hepatitis B surface antigen [HBsAg] positive) and/or human immunodeficiency virus (HIV).
    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

    Learn more about this trial

    Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005)

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