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Safety and Efficacy of BMS-790052 Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01017575
First received: November 19, 2009
Last updated: November 29, 2011
Last verified: June 2010

November 19, 2009
November 29, 2011
December 2009
October 2011   (final data collection date for primary outcome measure)
  • Safety and tolerability, as measured by the frequency of SAEs, discontinuations due to AEs, and Grade 3 - 4 laboratory abnormalities [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
  • Safety and tolerability, as measured by the frequency of SAEs, discontinuations due to 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 < 15 IU/mL [ Time Frame: at both Weeks 4 and 12 ] [ Designated as safety issue: Yes ]
  • Safety and tolerability, as measured by the frequency of SAEs, discontinuations due to AEs, and Grade 3 - 4 laboratory abnormalities [ Time Frame: Weeks 4 and 12 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01017575 on ClinicalTrials.gov Archive Site
  • Proportion of subjects with rapid virologic response (RVR), defined as undetectable HCV RNA [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA from baseline [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Proportions of subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Proportions of subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
  • Resistant variants associated with virologic failure [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
  • Resistant variants associated with virologic failure [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Resistant variants associated with virologic failure [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with rapid virologic response (RVR), defined as HCV RNA < 15 IU/mL [ Time Frame: at Week 4 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with early virologic response (EVR), defined as ≥ 2 log10 decrease in HCV RNA from baseline [ Time Frame: at Week 12 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA < 15 IU/mL at follow-up (SVR12) and (SVR24), respectively [ Time Frame: Week 12 (SVR12) and Week 24 (SVR24), respectively ] [ Designated as safety issue: Yes ]
  • Resistant variants associated with clinical failure [ Time Frame: Weeks 4, 12, post-treatment Week 24 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Safety and Efficacy of BMS-790052 Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)
A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a(Pegasys®) and Ribavirin (Copegus®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

The purpose of this study is to identify at least 1 dose of BMS-790052, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious

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 Infection
  • Drug: BMS-790052
    Tablets, Oral, 10 mg, daily, 24-48 weeks
  • Drug: BMS-790052
    Tablets, Oral, 60 mg, daily, 24-48 weeks
  • Drug: Placebo
    Tablets, Oral, 0 mg, daily, 48 weeks
  • Drug: Peginterferon alfa-2a
    Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
    Other Name: Pegasys®
  • Drug: Ribavirin
    Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
    Other Name: Copegus®
  • Experimental: Arm A (BMS-790052, plus Peginterferon alfa-2a, Ribavirin)
    Treatment Naive
    Interventions:
    • Drug: BMS-790052
    • Drug: Peginterferon alfa-2a
    • Drug: Ribavirin
  • Experimental: Arm B (BMS-790052, plus Peginterferon alfa-2a, Ribavirin)
    Treatment Naive
    Interventions:
    • Drug: BMS-790052
    • Drug: Peginterferon alfa-2a
    • Drug: Ribavirin
  • Placebo Comparator: Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)
    Treatment Naive
    Interventions:
    • Drug: Placebo
    • Drug: Peginterferon alfa-2a
    • Drug: Ribavirin
  • Experimental: Arm D (BMS-790052, plus peginterferon alfa-2a, Ribavirin)
    Non-Responder
    Interventions:
    • Drug: BMS-790052
    • Drug: Peginterferon alfa-2a
    • Drug: Ribavirin
  • Experimental: Arm E (BMS-790052, plus Peginterferon alfa-2a, Ribavirin)
    Non-Responder
    Interventions:
    • Drug: BMS-790052
    • Drug: Peginterferon alfa-2a
    • Drug: Ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
October 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects chronically infected with HCV genotype 1
  • HCV RNA viral load ≥ 10*5* IU/mL (100,000 IU/mL) at screening
  • The current standard of care naïve or non-responder

Exclusion Criteria:

  • Cirrhosis
  • HCC
  • Co-infection with HBV, HIV-1 or HIV-2
Both
20 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01017575
AI444-022
No
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2010

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