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Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin

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: July 5, 2012
Last verified: July 2012

October 2, 2009
July 5, 2012
November 2009
July 2010   (final data collection date for primary outcome measure)
  • Safety and tolerability will be measured by clinical assessments and standard safety laboratory parameters. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Antiviral activity at Day 15 will be measured by plasma HCV RNA concentration. [ Time Frame: Day 15 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01011166 on ClinicalTrials.gov Archive Site
  • Antiviral activity at Day 28 will be measured by plasma HCV RNA concentration. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics will be measured by plasma IDX184 and 2'-MeG concentrations. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin
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 (IFN)/Ribavirin (RBV). These data will guide dose selection for future, longer term studies.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Hepatitis C Infection
Drug: IDX184
4:1 (active:placebo)
  • Experimental: IDX184 50 mg QD + P/R
    Subjects randomized 4:1 (active:placebo) to receive IDX184 50 mg orally once daily in combination with Peg-IFN/RBV.
    Intervention: Drug: IDX184
  • Experimental: IDX184 50 mg BID + P/R
    Subjects randomized 4:1 (active:placebo) to receive IDX184 50 mg orally twice daily in combination with Peg-IFN/RBV.
    Intervention: Drug: IDX184
  • Experimental: IDX184 100 mg QD + P/R
    Subjects randomized 4:1 (active:placebo) to receive IDX184 100 mg orally once daily in combination with Peg-IFN/RBV.
    Intervention: Drug: IDX184
  • Experimental: IDX184 150 mg QD + P/R
    Subjects randomized 4:1 (active:placebo) to receive IDX184 150 mg orally once daily in combination with Peg-IFN/RBV.
    Intervention: Drug: IDX184
  • Experimental: IDX184 100 mg BID + P/R
    Subjects randomized 4:1 (active:placebo) to receive IDX184 100 mg orally twice daily in combination with Peg-IFN/RBV.
    Intervention: Drug: IDX184
  • Experimental: IDX184 200 mg QD + P/R
    Subjects randomized 4:1 (active:placebo) to receive IDX184 200 mg orally once daily in combination with Peg-IFN/RBV.
    Intervention: Drug: IDX184
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must be practicing birth control or must not be of childbearing potential
  • Documented chronic hepatitis C, genotype 1

Exclusion Criteria:

  • Previous antiviral treatment for hepatitis C infection
  • Cirrhosis or decompensated liver disease
  • Pregnant or breastfeeding
  • Body Mass Index (BMI) > 35.
  • Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV)
  • Clinically significant concomitant disease
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01011166
IDX-08C-004
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
July 2012

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