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

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:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Interferon Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

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

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pol S, Ghalib RH, Rustgi VK, Martorell C, Everson GT, Tatum HA, Hézode C, Lim JK, Bronowicki JP, Abrams GA, Bräu N, Morris DW, Thuluvath PJ, Reindollar RW, Yin PD, Diva U, Hindes R, McPhee F, Hernandez D, Wind-Rotolo M, Hughes EA, Schnittman S. Daclatasvir for previously untreated chronic hepatitis C genotype-1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial. Lancet Infect Dis. 2012 Sep;12(9):671-7. doi: 10.1016/S1473-3099(12)70138-X. Epub 2012 Jun 18.

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 May 16, 2013