Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01030432
First received: December 10, 2009
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to identify one or more doses of BMS-650032 that, when used in combination with pegylated-interferon alpha and ribavirin are safe and demonstrate sufficient activity against hepatitis C virus (Genotypes 1 and 4).


Condition Intervention Phase
Hepatitis C Virus
Drug: BMS-650032
Drug: Placebo
Drug: Peginterferon Alfa-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/2b Study of BMS-650032 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naive Subjects With Genotypes 1 and 4 Chronic Hepatitis C Infection

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs [ Time Frame: 12 weeks after first dose ] [ Designated as safety issue: Yes ]
  • Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
  • Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Phase 2b only: Antiviral activity, as determined by the proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA [ Time Frame: at follow-up Week 24 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of HCV genotype 1 subjects with rapid virologic response (RVR), defined as undetectable HCV RNA at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Proportion of HCV genotype 1 subjects with complete early rapid virologic response (eEVR), defined as undetectable HCV RNA at Week 12 (Stage 2 only) [ Time Frame: at Week 12 (Stage 2 only) ] [ Designated as safety issue: No ]
  • Proportion of HCV genotype 1 subjects with early virologic response (EVR) defined as ≥2 log10 decrease in HCV RNA from baseline at Week 12 (Stage 1 only) [ Time Frame: Week 12 (Stage 1 only) ] [ Designated as safety issue: No ]
  • Proportion of HCV genotype 1 subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA at follow-up Week 12 [ Time Frame: follow-up Week 12 ] [ Designated as safety issue: No ]
  • Proportion of HCV genotype 1 subjects with 24-week sustained virologic response (SVR24) defined as undetectable HCV RNA at follow-up Week 24 (Stage 1 only) [ Time Frame: follow-up Week 24 (Stage 1 only) ] [ Designated as safety issue: No ]
  • Resistant variants associated with virologic failure [ Time Frame: 48 weeks after last dose ] [ Designated as safety issue: No ]

Enrollment: 285
Study Start Date: February 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 2a: Arm 1 Drug: BMS-650032
Tablets, Oral, 200 mg, Twice Daily, 48 weeks
Drug: Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
Other Name: Pegasys
Drug: Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
Other Name: Copegus
Placebo Comparator: Phase 2a: Arm 2 Drug: Placebo
Tablets, Oral, 0 mg, twice daily, 48 weeks
Other Name: Pegasys
Drug: Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
Other Name: Pegasys
Drug: Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
Other Name: Copegus
Experimental: Phase 2b: Arm 1 Drug: BMS-650032
Tablets, Oral, 200 mg, Twice Daily, 12 or 24 weeks, depending on response
Drug: Placebo
Tablets, Oral, 0 mg, twice daily, 0 or 12 weeks (depending on response) beginning at Week 12
Drug: Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 24 or 48 weeks, depending on response
Other Name: Pegasys
Drug: Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 24 or 48 weeks depending on response
Other Name: Pegasys
Placebo Comparator: Phase 2b: Arm 2 Drug: Placebo
Tablets, Oral, 0 mg, twice daily 24 weeks
Drug: Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
Other Name: Pegasys
Drug: Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice 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 HCV genotype 1 (Phase 2a and Phase 2b)
  • Subjects chronically infected with HCV genotype 4 (Phase 2b only)
  • HCV RNA viral load of ≥ 10*5* IU/mL at screening
  • BMI of 18 - 35 kg/m² at screening

Exclusion Criteria:

  • Cirrhosis (Phase 2a only)
  • Decompensated cirrhosis (Phase 2b)
  • Co-infection with HBV or HIV
  • Hepatocellular carcinoma
  • Prior treatment with anti-HCV drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030432

  Hide Study Locations
Locations
United States, Alabama
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294-0006
Alabama Liver & Digestive Specialists (Alds)
Montgomery, Alabama, United States, 36116
United States, Florida
Florida Hospital Transplant Center
Orlando, Florida, United States, 32804
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
United States, Massachusetts
The Research Institute
Springfield, Massachusetts, United States, 01105
Umass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, New York
James J Peters Vamc
Bronx, New York, United States, 10468
United States, North Carolina
University Of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Oklahoma
Healthcare Research Consultants
Tulsa, Oklahoma, United States, 74135-2920
United States, Oregon
Oregon Health Science Univ
Portland, Oregon, United States, 97239
United States, Pennsylvania
Hospital Of The University Of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Gastro One
Germantown, Tennessee, United States, 38138
United States, Virginia
Metropolitan Research
Fairfax, Virginia, United States, 22031
United States, Wisconsin
Dean Clinic
Madison, Wisconsin, United States, 53715
Argentina
Local Institution
Ciudad De Buenos Aires, Buenos Aires, Argentina, C1121ABE
Local Institution
Prov. Buenos Aires, Buenos Aires, Argentina, 1629
Local Institution
Prov De Santa Fe, Santa Fe, Argentina, 2000
Local Institution
Buenos Aires, Argentina, C1181
France
Local Institution
Creteil Cedex, France, 94010
Local Institution
Marseille Cedex 08, France, 13285
Local Instituition
Montpellier Cedex 5, France, 34295
Local Institution
Paris Cedex 13, France, 75651
Local Institution
Paris Cedex 14, France, 75679
Local Institution
Vandoeuvre Les Nancy, France, 54511
Germany
Local Institution
Frankfurt, Germany, 60590
Local Institution
Heidelberg, Germany, 69120
Local Institution
Mainz, Germany, 55131
Local Institution
Wurzburg, Germany, 97080
Ireland
Local Institution
Dublin, Ireland, DUBLIN 7
Italy
Local Institution
Torino, Italy, 10126
Spain
Local Institution
Alicante, Spain, 03010
Local Institution
Barcelona, Spain, 08035
Local Institution
Madrid, Spain, 28222
Local Institution
Malaga, Spain, 29010
Local Institution
Valencia, Spain, 46010
United Kingdom
Local Institution
London, Greater London, United Kingdom, SE5 9RS
Local Institution
London, Greater London, United Kingdom, E1 2AT
Local Institution
London, Greater London, United Kingdom, W2 1NY
Local Institution
Manchester, Greater Manchester, United Kingdom, M8 5RB
Local Institution
Glasgow, Lanarkshire, United Kingdom, G12 0YN
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01030432     History of Changes
Other Study ID Numbers: AI447-016, 2009-013652-69
Study First Received: December 10, 2009
Last Updated: June 20, 2013
Health Authority: United States: Food and Drug Administration
France: Ministry of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Ireland: Irish Medicines Board
Spain: Spanish Agency of Medicines
Italy: The Italian Medicines Agency

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

ClinicalTrials.gov processed this record on July 23, 2014