Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01030432
First received: December 10, 2009
Last updated: June 20, 2013
Last verified: June 2013

December 10, 2009
June 20, 2013
February 2010
October 2012   (final data collection date for primary outcome measure)
  • Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs [ Time Frame: 12 weeks after first dose ] [ Designated as safety issue: Yes ]
  • Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
  • Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Phase 2b only: Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA [ Time Frame: at follow-up Week 24 ] [ Designated as safety issue: Yes ]
  • Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs [ Time Frame: Phase 2a - 12 weeks after first dose, Phase 2b - 12 and 72 weeks after first dose ] [ Designated as safety issue: Yes ]
  • Phase 2a and Phase 2b: Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA at both Weeks 4 and 12 [ Time Frame: Phase 2a - 12 weeks after first dose, Phase 2b - 12 and 72 weeks after first dose ] [ Designated as safety issue: Yes ]
  • Phase 2b ONLY: Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA at follow-up Week 24 [ Time Frame: 12 and 72 weeks after first dose ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01030432 on ClinicalTrials.gov Archive Site
  • Proportion of HCV genotype 1 subjects with rapid virologic response (RVR), defined as undetectable HCV RNA at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Proportion of HCV genotype 1 subjects with complete early rapid virologic response (eEVR), defined as undetectable HCV RNA at Week 12 (Stage 2 only) [ Time Frame: at Week 12 (Stage 2 only) ] [ Designated as safety issue: No ]
  • Proportion of HCV genotype 1 subjects with early virologic response (EVR) defined as ≥2 log10 decrease in HCV RNA from baseline at Week 12 (Stage 1 only) [ Time Frame: Week 12 (Stage 1 only) ] [ Designated as safety issue: No ]
  • Proportion of HCV genotype 1 subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA at follow-up Week 12 [ Time Frame: follow-up Week 12 ] [ Designated as safety issue: No ]
  • Proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24) defined as undetectable HCV RNA at follow-up Week 24 (Stage 1 only) [ Time Frame: follow-up Week 24 (Stage 1 only) ] [ Designated as safety issue: No ]
  • Resistant variants associated with virologic failure [ Time Frame: 48 weeks after last dose ] [ Designated as safety issue: No ]
  • Proportion of HCV genotype 1 subjects with rapid virologic response (RVR), defined as undetectable HCV RNA at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Proportion of HCV genotype 1 subjects with early virologic response (EVR) defined as ≥ 2 log10 decrease in HCV RNA from baseline at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Proportion of HCV genotype 1 subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA at follow-up Week 12 [ Time Frame: 12 weeks after last dose ] [ Designated as safety issue: No ]
  • Describe the resistant variants associated with virologic failure [ Time Frame: 48 weeks after last dose ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin
A Phase 2a/2b Study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotypes 1 and 4 Chronic Hepatitis C Infection

The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).

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 Virus
  • Drug: BMS-650032
    Tablets, Oral, 200 mg, Twice Daily, 48 weeks
  • Drug: BMS-650032
    Tablets, Oral, 200 mg, Twice Daily, 12 or 24 weeks, depending on response
  • Drug: Placebo
    Tablets, Oral, 0 mg, twice daily, 48 weeks
    Other Name: Pegasys
  • Drug: Placebo
    Tablets, Oral, 0 mg, twice daily, 0 or 12 weeks (depending on response) beginning at Week 12
  • Drug: Placebo
    Tablets, Oral, 0 mg, twice daily 24 weeks
  • Drug: Peginterferon Alfa-2a
    Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
    Other Name: Pegasys
  • Drug: Peginterferon Alfa-2a
    Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 24 or 48 weeks, depending on response
    Other Name: Pegasys
  • Drug: Ribavirin
    Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
    Other Name: Copegus
  • Drug: Ribavirin
    Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 24 or 48 weeks depending on response
    Other Name: Pegasys
  • Experimental: Phase 2a: Arm 1
    Interventions:
    • Drug: BMS-650032
    • Drug: Peginterferon Alfa-2a
    • Drug: Ribavirin
  • Placebo Comparator: Phase 2a: Arm 2
    Interventions:
    • Drug: Placebo
    • Drug: Peginterferon Alfa-2a
    • Drug: Ribavirin
  • Experimental: Phase 2b: Arm 1
    Interventions:
    • Drug: BMS-650032
    • Drug: Placebo
    • Drug: Peginterferon Alfa-2a
    • Drug: Ribavirin
  • Placebo Comparator: Phase 2b: Arm 2
    Interventions:
    • Drug: Placebo
    • 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
285
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects chronically infected with HCV genotype 1 (Phase 2a and Phase 2b)
  • Subjects chronically infected with HCV genotype 4 (Phase 2b only)
  • HCV RNA viral load of ≥ 10*5* IU/mL at screening
  • BMI of 18 - 35 kg/m² at screening

Exclusion Criteria:

  • Cirrhosis (Phase 2a only)
  • Decompensated cirrhosis (Phase 2b)
  • Co-infection with HBV or HIV
  • Hepatocellular carcinoma
  • Prior treatment with anti-HCV drugs
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   France,   Germany,   Ireland,   Italy,   Spain,   United Kingdom
 
NCT01030432
AI447-016, 2009-013652-69
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2013

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