Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01448044
First received: October 5, 2011
Last updated: May 5, 2014
Last verified: May 2014

October 5, 2011
May 5, 2014
December 2011
October 2013   (final data collection date for primary outcome measure)
Compare rates of Sustained Virologic Response (SVR12) for Hepatitis C virus (HCV) Genotype 4 subjects treated with either BMS-790052 or placebo in combination with pegIFNα-2a/RBV [ Time Frame: Week 12 follow up ] [ Designated as safety issue: No ]
compare rates of Sustained Virologic Response (SVR12) for Hepatitis C virus (HCV) Genotype 1 subjects treated with either BMS-790052 or placebo in combination with pegIFNα-2a/RBV [ Time Frame: Week 12 follow up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01448044 on ClinicalTrials.gov Archive Site
  • Proportion of subjects who achieve HCV Ribonucleic acid (RNA) < Limit of quantification (LOQ) [ Time Frame: Weeks 1, 2, 4, 6, 8 and 12; at both weeks 4 and 12 VR (4 & 12); EOT (up to 48 weeks); post-treatment week 24 (SVR24); or post-treatment Week 48 for subjects who achieve VR(4&12) defined as HCV RNA undetectable at weeks 4 and 12 ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve HCV RNA undetectable [ Time Frame: Weeks 1, 2, 4, 6, 8, and 12; at both weeks 4 and 12 (VR4&12); EOT; post-treatment week 12; post-treatment week 24; or post-treatment Week 48 for subjects who achieve Virologic response at week 4 and week 12 [VR(4&12)] ] [ Designated as safety issue: No ]
  • Frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) for each cohort on treatment [ Time Frame: Maximum of 48 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with SVR12 or SVR24 by rs12979860 Single nucleotide polymorphism (SNP) in the IL28B gene [ Time Frame: Post-treatment week 12 and post treatment week 24 ] [ Designated as safety issue: No ]
  • Proportion of genotype 4 subjects with SVR12 for each cohort [ Time Frame: Post-treatment week 12 ] [ Designated as safety issue: No ]
  • Proportion of HCV Genotype 1 or 4 subjects who achieve HCV Ribonucleic acid (RNA) < Limit of quantification (LOQ) [ Time Frame: Weeks 1, 2, 4, 6, 8 and 12; at both weeks 4 and 12; EOT (up to 48 weeks); post-treatment week 24 (SVR24); or post-treatment Week 48 for subjects who achieve VR(4&12) defined as HCV RNA undetectable at weeks 4 and 12 ] [ Designated as safety issue: No ]
  • Proportion of HCV Genotype 1 or 4 subjects who achieve HCV RNA undetectable [ Time Frame: Weeks 1, 2, 4, 6, 8, and 12; at both weeks 4 and 12 (VR4&12); EOT; post-treatment week 12; post-treatment week 24; or post-treatment Week 48 for subjects who achieve Virologic response at week 4 and week 12 [VR(4&12)] ] [ Designated as safety issue: No ]
  • Frequency of Serious Adverse Events (SAEs) and discontinuations due to Adverse Events (AEs) for each cohort on treatment [ Time Frame: Maximum of 48 weeks ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with SVR12 or SVR24 by rs12979860 Single nucleotide polymorphism (SNP) in the IL28B gene [ Time Frame: Post-treatment week 12 and post treatment week 24 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C
A Phase 3 Evaluation of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 4

The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hepatitis C
  • Drug: BMS-790052 (NS5A Replication Complex Inhibitor)
  • Drug: Placebo matching BMS-790052
  • Drug: Pegylated-interferon alfa 2a
    Other Name: Pegasys
  • Drug: Ribavirin
    Other Name: Copegus
  • Experimental: BMS-790052 + PegIFNα-2a + Ribavirin
    • BMS-790052 60 mg Tablets, Oral, once daily for 24 weeks
    • PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 24 or 48 weeks depending on response
    • Ribavirin 400 mg (2 tablets for subjects < 75 kg) or 600 mg (3 tablets for subjects ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 24 or 48 weeks depending on response
    Interventions:
    • Drug: BMS-790052 (NS5A Replication Complex Inhibitor)
    • Drug: Pegylated-interferon alfa 2a
    • Drug: Ribavirin
  • Placebo Comparator: Placebo matching BMS-790052 + PegIFNα-2a + Ribavirin
    • Placebo matching BMS-790052 0 mg Tablets, Oral, once daily for 48 weeks
    • PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 48 weeks
    • Ribavirin 400 mg (2 tablets for subjects < 75 kg) or 600 mg (3 tablets for subjects ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 48 weeks
    Interventions:
    • Drug: Placebo matching BMS-790052
    • Drug: Pegylated-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
125
January 2014
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects chronically infected with HCV Genotype 4
  • HCV RNA viral load of ≥ 10,000 IU/mL
  • No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent
  • Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Subjects with compensated cirrhosis are permitted, however, and any prior biopsy is permitted

Exclusion Criteria:

  • Evidence of decompensated liver disease
  • Documented or suspected Hepatocellular carcinoma (HCC)
  • Positive for Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Spain,   United Kingdom,   Greece,   Italy,   Mexico,   Puerto Rico,   United States
 
NCT01448044
AI444-042, 2011-002793-23
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2014

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