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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01011166
First received: October 2, 2009
Last updated: April 22, 2015
Last verified: April 2015
October 2, 2009
April 22, 2015
November 2009
July 2010   (Final data collection date for primary outcome measure)
  • Change in HCV ribonucleic acid (RNA) level from Baseline to Day 15 [ Time Frame: Baseline and Day 15 ]
  • Percentage of participants experiencing adverse events (AEs) [ Time Frame: Up to 28 days ]
  • Percentage of participants experiencing serious adverse events (SAEs) [ Time Frame: Up to 28 days ]
  • Percentage of participants experiencing dose-limiting toxicities (DLTs) [ Time Frame: Up to 28 days ]
  • Percentage of participants experiencing Grade 1-4 laboratory abnormalities [ Time Frame: Up to 28 days ]
  • Safety and tolerability will be measured by clinical assessments and standard safety laboratory parameters. [ Time Frame: 28 days ]
  • Antiviral activity at Day 15 will be measured by plasma HCV RNA concentration. [ Time Frame: Day 15 ]
Complete list of historical versions of study NCT01011166 on ClinicalTrials.gov Archive Site
  • Change in HCV RNA level from Baseline to Day 28 [ Time Frame: Baseline and Day 28 ]
  • Percentage of participants with undetectable HCV RNA at Day 15 [ Time Frame: Day 15 ]
  • Percentage of participants with undetectable HCV RNA at Day 28 [ Time Frame: Day 28 ]
  • Percentage of participants experiencing virologic breakthrough while on study therapy [ Time Frame: Up to 28 days ]
  • Change in alanine aminotransferase (ALT) level from Baseline to Day 15 [ Time Frame: Baseline and Day 15 ]
  • Change in ALT level from Baseline to Day 28 [ Time Frame: Baseline and Day 28 ]
  • Maximum concentration (Cmax) [ Time Frame: Up to 28 days ]
  • Time to maximum concentration (Tmax) [ Time Frame: Up to 28 days ]
  • Area under the drug concentration-time curve (AUC) from time 0 to last measurable concentration (AUC0-t) [ Time Frame: Up to 28 days ]
  • AUC from time zero to infinity (AUC0-~) [ Time Frame: Up to 28 days ]
  • Trough concentration (Ctrough) [ Time Frame: Up to 28 days ]
  • Observed terminal half-life (Thalf) [ Time Frame: Up to 28 days ]
  • Antiviral activity at Day 28 will be measured by plasma HCV RNA concentration. [ Time Frame: 28 days ]
  • Pharmacokinetics will be measured by plasma IDX184 and 2'-MeG concentrations. [ Time Frame: 28 days ]
Not Provided
Not Provided
 
Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin (MK-2355-004)
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Hepatitis C Infection
  • Drug: IDX184
    IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.
  • Drug: Placebo
    Placebo white opaque capsules taken by mouth from Day 1 to Day 14.
  • Biological: Peginterferon alfa-2a (Peg-IFN)
    Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.
    Other Name: Pegasys
  • Drug: Ribavirin (RBV)
    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.
  • Experimental: IDX184 50 mg QD + Peg-IFN/RBV
    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.
    Interventions:
    • Drug: IDX184
    • Drug: Placebo
    • Biological: Peginterferon alfa-2a (Peg-IFN)
    • Drug: Ribavirin (RBV)
  • Experimental: IDX184 100 mg QD + Peg-IFN/RBV
    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.
    Interventions:
    • Drug: IDX184
    • Drug: Placebo
    • Biological: Peginterferon alfa-2a (Peg-IFN)
    • Drug: Ribavirin (RBV)
  • Experimental: IDX184 100 mg BID + Peg-IFN/RBV
    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.
    Interventions:
    • Drug: IDX184
    • Drug: Placebo
    • Biological: Peginterferon alfa-2a (Peg-IFN)
    • Drug: Ribavirin (RBV)
  • Experimental: IDX184 150 mg QD + Peg-IFN/RBV
    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.
    Interventions:
    • Drug: IDX184
    • Drug: Placebo
    • Biological: Peginterferon alfa-2a (Peg-IFN)
    • Drug: Ribavirin (RBV)
  • Experimental: IDX184 200 mg QD + Peg-IFN/RBV
    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.
    Interventions:
    • Drug: IDX184
    • Drug: Placebo
    • Biological: Peginterferon alfa-2a (Peg-IFN)
    • Drug: Ribavirin (RBV)
  • Experimental: IDX184 200 mg BID + Peg-IFN/RBV
    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.
    Interventions:
    • Drug: IDX184
    • Drug: Placebo
    • Biological: Peginterferon alfa-2a (Peg-IFN)
    • Drug: Ribavirin (RBV)
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-Bólyai J, Mayers D. IDX184 in combination with pegylated interferon-α2a 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
July 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01011166
2355-004
IDX-08C-004 ( Other Identifier: Idenix Protocol Number )
No
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Director Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP