Study of BMS-790052 Add-On to Standard of Care in Treatment Naive Subjects (HEPCAT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01125189
First received: May 17, 2010
Last updated: May 31, 2013
Last verified: May 2013

May 17, 2010
May 31, 2013
July 2010
April 2012   (final data collection date for primary outcome measure)
  • Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with extended rapid virologic response, defined as undetectable HCV RNA [ Time Frame: Week 4 and 12 ] [ Designated as safety issue: No ]
  • Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response, defined as undetectable HCV RNA [ Time Frame: Follow up Week 24 ] [ Designated as safety issue: No ]
  • Safety, as measured by the frequency of Serious Adverse Events and discontinuations due to Adverse Events [ Time Frame: Week 12, Week 24, and follow-up Week 12 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01125189 on ClinicalTrials.gov Archive Site
  • To assess the proportion of HCV genotype 1 subjects with rapid virologic response, ie, undetectable HCV RNA [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • To assess the proportion of HCV genotype 1 subjects with complete early virologic response, ie, undetectable HCV RNA [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • To assess the proportion of HCV genotype 1 subjects with 12-week sustained virologic response, ie, undetectable HCV RNA [ Time Frame: follow-up Week 12 ] [ Designated as safety issue: No ]
  • To describe resistant variants associated with virologic failure [ Time Frame: follow-up Week 48 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of BMS-790052 Add-On to Standard of Care in Treatment Naive Subjects
A Phase 2b Study of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection

At least 1 dose of BMS-790052 combined with Standard of Care (pegylated interferon and ribavirin) can be identified which is safe, well tolerated, and demonstrates extended rapid virologic response rates at least 35% greater than placebo.

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-790052
    Tablets, Oral, 20 mg, Once daily, 12-24 weeks, depending on response
  • Drug: BMS-790052
    Tablets, Oral, 60 mg, Once daily, 12-24 weeks, depending on response
  • Drug: Placebo
    Tablets, Oral, 0 mg, Once daily, 24 weeks
  • Drug: peg-interferon alfa-2a
    Syringe, Subcutaneous Injection, 180 µg, Once weekly, 24 or 48 weeks depending on response
    Other Name: Pegasys
  • Drug: ribavirin
    Tablets, Oral, 1000 or 1200 mg based on weight, Once daily, 24 or 48 weeks depending on response
    Other Name: Copegus
  • Experimental: BMS-790052 plus peg-interferon alfa-2a and ribavirin (20 mg)
    Interventions:
    • Drug: BMS-790052
    • Drug: peg-interferon alfa-2a
    • Drug: ribavirin
  • Experimental: BMS-790052 plus peg-interferon alfa-2a and ribavirin (60 mg)
    Interventions:
    • Drug: BMS-790052
    • Drug: peg-interferon alfa-2a
    • Drug: ribavirin
  • Placebo Comparator: Placebo plus peg-interferon alfa-2a and ribavirin
    Interventions:
    • Drug: Placebo
    • Drug: peg-interferon 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
395
August 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects chronically infected with HCV genotype 1 or 4
  • HCV RNA viral load of ≥ 100,000 IU/mL
  • No previous exposure to interferon, pegIFNα, or RBV
  • Results of a liver biopsy demonstrating absence of cirrhosis obtained ≤ 24 months prior to randomization. Compensated cirrhotics with HCV genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
  • Ultrasound, CT scan, or MRI results 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
  • Body Mass Index (BMI) of 18 to 35 kg/m²

Exclusion Criteria:

  • Positive for Hepatitis B or HIV-1/HIV-2 antibody at screening
  • Evidence of a medical condition associated with chronic liver disease other than HCV
  • Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Denmark,   Egypt,   France,   Germany,   Italy,   Mexico,   Puerto Rico,   Sweden
 
NCT01125189
AI444-010, 2010-018295-24
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2013

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