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Safety and Efficacy of BMS-790052 Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00874770
First received: April 2, 2009
Last updated: March 4, 2011
Last verified: March 2011

April 2, 2009
March 4, 2011
June 2009
November 2009   (final data collection date for primary outcome measure)
  • Safety, as measured by the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), and Grade 3 - 4 laboratory abnormalities [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
  • Safety, as measured by the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), and Grade 3 - 4 laboratory abnormalities [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as HCV RNA < 10 IU/mL at both Weeks 4 and 12 [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
  • Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as HCV RNA < 10 IU/mL at both Weeks 4 and 12 [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as HCV RNA < 10 IU/mL at both Weeks 4 and 12 [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00874770 on ClinicalTrials.gov Archive Site
  • Proportion of subjects with rapid virologic response (RVR), defined as HCV ribonucleic acid (RNA) < 10 IU/mL at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Proportion of subjects with early virologic response (EVR), defined as ≥ 2 log10 decrease in HCV RNA from baseline at Week 12 (or HCV RNA < 10 IU/mL for subjects with baseline HCV RNA < 1000 IU/mL) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA , 10 IU/mL at follow-up Week 12 (SVR12) and Week 24 (SVR24), respectively [ Time Frame: Follow-up Week 12 ] [ Designated as safety issue: No ]
  • Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA , 10 IU/mL at follow-up Week 12 (SVR12) and Week 24 (SVR24), respectively [ Time Frame: Follow-up Week 24 ] [ Designated as safety issue: No ]
  • Resistant variants associated with clinical failure [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Resistant variants associated with clinical failure [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Resistant variants associated with clinical failure [ Time Frame: Follow-up Week 12 ] [ Designated as safety issue: No ]
  • Resistant variants associated with clinical failure [ Time Frame: Follow-up Week 24 ] [ Designated as safety issue: No ]
Safety, as measured by the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), and Grade 3 - 4 laboratory abnormalities and, [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Safety and Efficacy of BMS-790052 Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)
A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype 1

The purpose of this study is to identify one or more doses of BMS-790052, that when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient anti-Hepatitis C Virus (HCV) activity.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hepatitis C
  • Drug: BMS-790052
    Tablets, Oral, 3 mg, Daily, 48 weeks
  • Drug: BMS-790052
    Tablets, Oral, 10 mg, Daily, 48 weeks
  • Drug: BMS-790052
    Tablets, Oral, 60 mg, Daily, 48 weeks
  • Drug: Placebo
    Tablet, Oral, 0 mg, Daily 48 weeks
  • Drug: Peginterferon alpha-2a
    Syringe, Subcutaneous, 180 ug, Weekly, 48 weeks
    Other Name: Pegasys
  • Drug: ribavirin
    Tablet, Oral, 1000 mg or 1200 mg, based on weight, Daily, 48 weeks
    Other Name: Copegus
  • Experimental: BMS-790052, plus Peginterferon alpha-2a, ribavirin (A)
    Active Comparator
    Interventions:
    • Drug: BMS-790052
    • Drug: Peginterferon alpha-2a
    • Drug: ribavirin
  • Experimental: BMS-790052, Peginterferon alpha-2a, ribavirin (B)
    Active Comparator
    Interventions:
    • Drug: BMS-790052
    • Drug: Peginterferon alpha-2a
    • Drug: ribavirin
  • Experimental: BMS-790052, Peginterferon alpha-2a, ribavirin (C)
    Active Comparator
    Interventions:
    • Drug: BMS-790052
    • Drug: Peginterferon alpha-2a
    • Drug: ribavirin
  • Active Comparator: Placebo, Peginterferon alpha-2a, ribavirin (D)
    Interventions:
    • Drug: Placebo
    • Drug: Peginterferon alpha-2a
    • Drug: ribavirin
Pol S, Ghalib RH, Rustgi VK, Martorell C, Everson GT, Tatum HA, Hézode C, Lim JK, Bronowicki JP, Abrams GA, Bräu N, Morris DW, Thuluvath PJ, Reindollar RW, Yin PD, Diva U, Hindes R, McPhee F, Hernandez D, Wind-Rotolo M, Hughes EA, Schnittman S. Daclatasvir for previously untreated chronic hepatitis C genotype-1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial. Lancet Infect Dis. 2012 Sep;12(9):671-7. doi: 10.1016/S1473-3099(12)70138-X. Epub 2012 Jun 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
January 2011
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects chronically infected with Hepatitis C Virus (HCV) genotype 1
  • HCV ribonucleic acid (RNA) viral load of ≥ 10*5* IU/mL (100,000 IU/mL) at screening
  • Treatment naive

Exclusion Criteria:

  • Women of Child Bearing Potential
  • Cirrhosis
  • Co infection with Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   France
 
NCT00874770
AI444-014, EUDRACT# 2009-010149-29
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
March 2011

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