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Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin (MK-2355-004)

Primary Purpose

Chronic Hepatitis C Infection

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
IDX184
Placebo
Peginterferon alfa-2a (Peg-IFN)
Ribavirin (RBV)
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 Infection focused on measuring Chronic Hepatitis C, HepC, Hep C

Eligibility Criteria

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

Inclusion Criteria:

  • Has documented chronic HCV GT1 infection
  • Agrees to use of double-barrier contraception and males agree not to donate sperm from the first dose of study therapy through at least 6 months after the final dose of study therapy

Exclusion Criteria:

  • Has received previous antiviral treatment for HCV infection
  • Has cirrhosis or decompensated liver disease
  • Is pregnant or breastfeeding
  • Is co-infected with hepatitis B virus (e.g., hepatitis B surface antigen [HBsAg] positive) and/or human immunodeficiency virus (HIV)
  • Has clinically significant concomitant disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    IDX184 50 mg QD + Peg-IFN/RBV

    IDX184 100 mg QD + Peg-IFN/RBV

    IDX184 100 mg BID + Peg-IFN/RBV

    IDX184 150 mg QD + Peg-IFN/RBV

    IDX184 200 mg QD + Peg-IFN/RBV

    IDX184 200 mg BID + Peg-IFN/RBV

    Arm Description

    Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo once daily (QD) in combination with Peg-IFN/RBV on Days 14-28 and Peg-IFN/RBV on Days 14-28.

    Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.

    Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo twice daily (BID) in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.

    Participants randomized 4:1 (active:placebo) to receive IDX184 150 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.

    Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.

    Participants randomized 4:1 (active:placebo) to receive IDX184 200 mg or placebo BID in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.

    Outcomes

    Primary Outcome Measures

    Change in HCV ribonucleic acid (RNA) level from Baseline to Day 15
    Percentage of participants experiencing adverse events (AEs)
    Percentage of participants experiencing serious adverse events (SAEs)
    Percentage of participants experiencing dose-limiting toxicities (DLTs)
    Percentage of participants experiencing Grade 1-4 laboratory abnormalities

    Secondary Outcome Measures

    Change in HCV RNA level from Baseline to Day 28
    Percentage of participants with undetectable HCV RNA at Day 15
    Percentage of participants with undetectable HCV RNA at Day 28
    Percentage of participants experiencing virologic breakthrough while on study therapy
    Change in alanine aminotransferase (ALT) level from Baseline to Day 15
    Change in ALT level from Baseline to Day 28
    Maximum concentration (Cmax)
    Time to maximum concentration (Tmax)
    Area under the drug concentration-time curve (AUC) from time 0 to last measurable concentration (AUC0-t)
    AUC from time zero to infinity (AUC0-~)
    Trough concentration (Ctrough)
    Observed terminal half-life (Thalf)

    Full Information

    First Posted
    October 2, 2009
    Last Updated
    April 22, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01011166
    Brief Title
    Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin (MK-2355-004)
    Official Title
    A Phase II, Randomized, Double-Blind Study to Evaluate the Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin in Subjects With Genotype 1 Chronic Hepatitis C Infection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2009 (undefined)
    Primary Completion Date
    July 2010 (Actual)
    Study Completion Date
    July 2010 (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 will assess short term safety, antiviral activity and pharmacokinetics (PK) of IDX184 in combination with Peg-interferon (Peg-IFN)/Ribavirin (RBV) in participants with hepatitis C virus (HCV) genotype (GT) 1 infection. These data will guide dose selection for future, longer term studies.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    81 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IDX184 50 mg QD + Peg-IFN/RBV
    Arm Type
    Experimental
    Arm Description
    Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo once daily (QD) in combination with Peg-IFN/RBV on Days 14-28 and Peg-IFN/RBV on Days 14-28.
    Arm Title
    IDX184 100 mg QD + Peg-IFN/RBV
    Arm Type
    Experimental
    Arm Description
    Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.
    Arm Title
    IDX184 100 mg BID + Peg-IFN/RBV
    Arm Type
    Experimental
    Arm Description
    Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo twice daily (BID) in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.
    Arm Title
    IDX184 150 mg QD + Peg-IFN/RBV
    Arm Type
    Experimental
    Arm Description
    Participants randomized 4:1 (active:placebo) to receive IDX184 150 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
    Arm Title
    IDX184 200 mg QD + Peg-IFN/RBV
    Arm Type
    Experimental
    Arm Description
    Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
    Arm Title
    IDX184 200 mg BID + Peg-IFN/RBV
    Arm Type
    Experimental
    Arm Description
    Participants randomized 4:1 (active:placebo) to receive IDX184 200 mg or placebo BID in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
    Intervention Type
    Drug
    Intervention Name(s)
    IDX184
    Intervention Description
    IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo white opaque capsules taken by mouth from Day 1 to Day 14.
    Intervention Type
    Biological
    Intervention Name(s)
    Peginterferon alfa-2a (Peg-IFN)
    Other Intervention Name(s)
    Pegasys
    Intervention Description
    Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.
    Intervention Type
    Drug
    Intervention Name(s)
    Ribavirin (RBV)
    Intervention Description
    RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28.
    Primary Outcome Measure Information:
    Title
    Change in HCV ribonucleic acid (RNA) level from Baseline to Day 15
    Time Frame
    Baseline and Day 15
    Title
    Percentage of participants experiencing adverse events (AEs)
    Time Frame
    Up to 28 days
    Title
    Percentage of participants experiencing serious adverse events (SAEs)
    Time Frame
    Up to 28 days
    Title
    Percentage of participants experiencing dose-limiting toxicities (DLTs)
    Time Frame
    Up to 28 days
    Title
    Percentage of participants experiencing Grade 1-4 laboratory abnormalities
    Time Frame
    Up to 28 days
    Secondary Outcome Measure Information:
    Title
    Change in HCV RNA level from Baseline to Day 28
    Time Frame
    Baseline and Day 28
    Title
    Percentage of participants with undetectable HCV RNA at Day 15
    Time Frame
    Day 15
    Title
    Percentage of participants with undetectable HCV RNA at Day 28
    Time Frame
    Day 28
    Title
    Percentage of participants experiencing virologic breakthrough while on study therapy
    Time Frame
    Up to 28 days
    Title
    Change in alanine aminotransferase (ALT) level from Baseline to Day 15
    Time Frame
    Baseline and Day 15
    Title
    Change in ALT level from Baseline to Day 28
    Time Frame
    Baseline and Day 28
    Title
    Maximum concentration (Cmax)
    Time Frame
    Up to 28 days
    Title
    Time to maximum concentration (Tmax)
    Time Frame
    Up to 28 days
    Title
    Area under the drug concentration-time curve (AUC) from time 0 to last measurable concentration (AUC0-t)
    Time Frame
    Up to 28 days
    Title
    AUC from time zero to infinity (AUC0-~)
    Time Frame
    Up to 28 days
    Title
    Trough concentration (Ctrough)
    Time Frame
    Up to 28 days
    Title
    Observed terminal half-life (Thalf)
    Time Frame
    Up to 28 days

    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: Has documented chronic HCV GT1 infection Agrees to use of double-barrier contraception and males agree not to donate sperm from the first dose of study therapy through at least 6 months after the final dose of study therapy Exclusion Criteria: Has received previous antiviral treatment for HCV infection Has cirrhosis or decompensated liver disease Is pregnant or breastfeeding Is co-infected with hepatitis B virus (e.g., hepatitis B surface antigen [HBsAg] positive) and/or human immunodeficiency virus (HIV) Has clinically significant concomitant disease
    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

    Citations:
    PubMed Identifier
    23439365
    Citation
    Lalezari J, Box T, O'Riordan W, Mehra P, Nguyen T, Poordad F, Dejesus E, Kwo P, Godofsky E, Lawrence S, Dubuc-Patrick G, Chen J, McCarville J, Pietropaolo K, Zhou XJ, Sullivan-Bolyai J, Mayers D. IDX184 in combination with pegylated interferon-alpha2a and ribavirin for 2 weeks in treatment-naive patients with chronic hepatitis C. Antivir Ther. 2013;18(6):755-64. doi: 10.3851/IMP2552. Epub 2013 Feb 25.
    Results Reference
    result

    Learn more about this trial

    Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin (MK-2355-004)

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