Safety and Efficacy of BMS-790052 Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00874770
First received: April 2, 2009
Last updated: March 4, 2011
Last verified: March 2011
  Purpose

The purpose of this study is to identify one or more doses of BMS-790052, that when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient anti-Hepatitis C Virus (HCV) activity.


Condition Intervention Phase
Hepatitis C
Drug: BMS-790052
Drug: Placebo
Drug: Peginterferon alpha-2a
Drug: ribavirin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a Study of BMS-790052 in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype 1

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety, as measured by the frequency of serious adverse events (SAEs), discontinuations due to adverse events (AEs), and Grade 3 - 4 laboratory abnormalities [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
  • Safety, as measured by the frequency of serious adverse events (SAEs), discontinuations due to adverse events (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 < 10 IU/mL at both Weeks 4 and 12 [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
  • Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as HCV RNA < 10 IU/mL at both Weeks 4 and 12 [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of subjects with rapid virologic response (RVR), defined as HCV ribonucleic acid (RNA) < 10 IU/mL at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Proportion of subjects with early virologic response (EVR), defined as ≥ 2 log10 decrease in HCV RNA from baseline at Week 12 (or HCV RNA < 10 IU/mL for subjects with baseline HCV RNA < 1000 IU/mL) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA , 10 IU/mL at follow-up Week 12 (SVR12) and Week 24 (SVR24), respectively [ Time Frame: Follow-up Week 12 ] [ Designated as safety issue: No ]
  • Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA , 10 IU/mL at follow-up Week 12 (SVR12) and Week 24 (SVR24), respectively [ Time Frame: Follow-up Week 24 ] [ Designated as safety issue: No ]
  • Resistant variants associated with clinical failure [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Resistant variants associated with clinical failure [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Resistant variants associated with clinical failure [ Time Frame: Follow-up Week 12 ] [ Designated as safety issue: No ]
  • Resistant variants associated with clinical failure [ Time Frame: Follow-up Week 24 ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: June 2009
Study Completion Date: January 2011
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-790052, plus Peginterferon alpha-2a, ribavirin (A)
Active Comparator
Drug: BMS-790052
Tablets, Oral, 3 mg, Daily, 48 weeks
Drug: Peginterferon alpha-2a
Syringe, Subcutaneous, 180 ug, Weekly, 48 weeks
Other Name: Pegasys
Drug: ribavirin
Tablet, Oral, 1000 mg or 1200 mg, based on weight, Daily, 48 weeks
Other Name: Copegus
Experimental: BMS-790052, Peginterferon alpha-2a, ribavirin (B)
Active Comparator
Drug: BMS-790052
Tablets, Oral, 10 mg, Daily, 48 weeks
Drug: Peginterferon alpha-2a
Syringe, Subcutaneous, 180 ug, Weekly, 48 weeks
Other Name: Pegasys
Drug: ribavirin
Tablet, Oral, 1000 mg or 1200 mg, based on weight, Daily, 48 weeks
Other Name: Copegus
Experimental: BMS-790052, Peginterferon alpha-2a, ribavirin (C)
Active Comparator
Drug: BMS-790052
Tablets, Oral, 60 mg, Daily, 48 weeks
Drug: Peginterferon alpha-2a
Syringe, Subcutaneous, 180 ug, Weekly, 48 weeks
Other Name: Pegasys
Drug: ribavirin
Tablet, Oral, 1000 mg or 1200 mg, based on weight, Daily, 48 weeks
Other Name: Copegus
Active Comparator: Placebo, Peginterferon alpha-2a, ribavirin (D) Drug: Placebo
Tablet, Oral, 0 mg, Daily 48 weeks
Drug: Peginterferon alpha-2a
Syringe, Subcutaneous, 180 ug, Weekly, 48 weeks
Other Name: Pegasys
Drug: ribavirin
Tablet, Oral, 1000 mg or 1200 mg, based on weight, Daily, 48 weeks
Other Name: Copegus

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects chronically infected with Hepatitis C Virus (HCV) genotype 1
  • HCV ribonucleic acid (RNA) viral load of ≥ 10*5* IU/mL (100,000 IU/mL) at screening
  • Treatment naive

Exclusion Criteria:

  • Women of Child Bearing Potential
  • Cirrhosis
  • Co infection with Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874770

Locations
United States, Alabama
Alabama Liver & Digestive Specialists (Alds)
Montgomery, Alabama, United States, 36116
United States, Colorado
University Of Colorado Denver & Hospital
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
United States, Massachusetts
Llc Dba The Research Institute
Springfield, Massachusetts, United States, 01107
United States, New York
Veterans Affairs Medical Center
Bronx, New York, United States, 10468
United States, North Carolina
Carolinas Center For Liver Disease
Statesville, North Carolina, United States, 28677
United States, Oklahoma
Options Health Research, Llc
Tulsa, Oklahoma, United States, 74104
Healthcare Research Consultants
Tulsa, Oklahoma, United States, 74135
United States, Texas
North Texas Research Institute
Arlington, Texas, United States, 76012
United States, Virginia
Metropolitan Research
Fairfax, Virginia, United States, 22031
France
Local Institution
Creteil, France, 94010
Local Institution
Paris Cedex 14, France, 75679
Local Institution
Vandoeuvre Les Nancy, France, 54511
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00874770     History of Changes
Other Study ID Numbers: AI444-014, EUDRACT# 2009-010149-29
Study First Received: April 2, 2009
Last Updated: March 4, 2011
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
France: Ministry of Health

Keywords provided by Bristol-Myers Squibb:
Antivirals

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Ribavirin
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 14, 2014