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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: September 11, 2015
Last verified: September 2015

October 5, 2011
September 11, 2015
December 2011
October 2013   (final data collection date for primary outcome measure)
Percentage of Participants With 12 Week Sustained Virologic Response (SVR12) [ Time Frame: Week 12 (Follow-up period) ] [ Designated as safety issue: No ]
Participants were assessed for sustained virologic response 12 weeks post treatment (SVR12) defined as hepatitis C virus (HCV) RNA levels < lower limit of quantitation (LLOQ was 25 IU/mL), target detected (TD) or target not detected (TND) at post-treatment Week 12.
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
  • Percentage of Participants Who Achieve HCV Ribonucleic Acid (RNA) < Limit of Quantification (LLOQ) [ Time Frame: Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12; End of treatment (EOT); Post treatment Week 24; Post treatment Week 48 ] [ Designated as safety issue: No ]
    Participants who achieved HCV RNA levels below LLOQ ie, 25 international unit per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.
  • Percentage of Participants With Undetectable Hepatitis C Virus (HCV) RNA Levels [ Time Frame: Treatment Weeks 1, 2, 4, 6, 8 and 12; Weeks 4 and 12, End of treatment (EOT), Post treatment Week 24, Post treatment Week 48 ] [ Designated as safety issue: No ]
    Participants who achieved HCV RNA undetectable ie, 10 international units per milliliter (IU/mL). Participants in the placebo arm did not have visits beyond post treatment Week 24.
  • Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) or Sustained Virologic Response at Follow-up Week 24 (SVR24) by rs12979860 Single Nucleotide Polymorphism (SNP) in the IL28B Gene [ Time Frame: Post Treatment Weeks 12, 24 ] [ Designated as safety issue: No ]
    Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR12 and SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 12 and Week 24 respectively.
  • Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died [ Time Frame: From Day 1 (start of study treatment) up to Follow-up Week 4 ] [ Designated as safety issue: Yes ]
    AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalisation.
  • 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 participants < 75 kg) or 600 mg (3 tablets for participants ≥ 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 participants < 75 kg) or 600 mg (3 tablets for participants ≥ 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
152
January 2014
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants 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. Participants 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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Greece,   Italy,   Puerto Rico,   Spain,   United Kingdom
Argentina,   Brazil,   Canada,   Czech Republic,   Egypt,   Hungary,   Mexico,   New Zealand,   Poland,   Romania,   Russian Federation,   Turkey
 
NCT01448044
AI444-042, 2011-002793-23
No
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
September 2015

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