A Study of BMS-824393 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype I

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01142700
First received: June 3, 2010
Last updated: March 14, 2011
Last verified: March 2011
  Purpose

Based on 12-week on-treatment data, at least 1 dose of BMS-824393 can be identified which is safe, well tolerated, and has sufficient antiviral activity to progress to late stage clinical trials when combined with pegIFNα/RBV for treatment of chronically infected hepatitis C virus genotype 1 treatment-naive subjects.


Condition Intervention Phase
Chronic Hepatitis C Virus Genotype 1
Drug: BMS-824393
Drug: Placebo
Drug: Peginterferon Alpha-2a
Drug: Ribavirin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Phase 2a Study of BMS-824393 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype I

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) and discontinuations due to adverse events (AEs) [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
  • Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
  • Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs) [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • Antiviral activity as determined by the proportion of 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 the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of subjects with rapid virologic response (RVR), defined as undetectable RNA [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable [ Time Frame: Week 12 (SVR12) ] [ Designated as safety issue: No ]
  • Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable [ Time Frame: Week 24 (SVR24) ] [ Designated as safety issue: No ]
  • Resistant variants associated with virologic failure [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Resistant variants associated with virologic failure [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Resistant variants associated with virologic failure [ Time Frame: Follow up Week 12 ] [ Designated as safety issue: No ]
  • Resistant variants associated with virologic failure [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BMS-824393 (10mg)

Plus Peginterferon Alfa-2a and Ribavirin

Day 1 - Week 12

Drug: BMS-824393
Capsule, Oral, 10 mg, once daily
Drug: Peginterferon Alpha-2a
Syringe, subcutaneous 180 mcg/0.5 mL, weekly
Other Name: Pegasys
Drug: Ribavirin
Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily
Other Name: Copegus
Experimental: BMS-824393 (30 mg)

Plus Peginterferon Alfa-2a and Ribavirin

Day 1 - Week 12

Drug: BMS-824393
Capsule, Oral, 30 mg, once daily
Drug: Peginterferon Alpha-2a
Syringe, subcutaneous 180 mcg/0.5 mL, weekly
Other Name: Pegasys
Drug: Ribavirin
Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily
Other Name: Copegus
Experimental: BMS-824393 (100 mg)

Plus Peginterferon Alfa-2a and Ribavirin

Day 1 - Week 12

Drug: BMS-824393
Capsule, Oral, 100 mg, once daily
Drug: Peginterferon Alpha-2a
Syringe, subcutaneous 180 mcg/0.5 mL, weekly
Other Name: Pegasys
Drug: Ribavirin
Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily
Other Name: Copegus
Placebo Comparator: Placebo

Plus Peginterferon Alfa-2a and Ribavirin

Day 1 - Week 12

Drug: Placebo
Capsule, Oral, 0 mg, once daily
Drug: Peginterferon Alpha-2a
Syringe, subcutaneous 180 mcg/0.5 mL, weekly
Other Name: Pegasys
Drug: Ribavirin
Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily
Other Name: Copegus
Peginterferon alfa-2a plus Ribavirin
Weeks 13 - 48
Drug: Peginterferon Alpha-2a
Syringe, subcutaneous 180 mcg/0.5 mL, weekly
Other Name: Pegasys
Drug: Ribavirin
Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily
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:

  • Treatment-naive subjects with genotype 1 chronic HCV
  • HCV RNA ≥ 100,000 IU/mL at screening
  • Seronegative for HIV and HBsAg
  • Liver biopsy within prior 2 years demonstrating no cirrhosis

Exclusion Criteria:

  • Any evidence of liver disease other than hepatitis C
  • Diagnosed or suspected hepatocellular carcinoma
  • Laboratory values: neutrophil count < 1500 cells/μL, platelet count < 90,000/μL; Hemoglobin ≤ 12 g/dL (120g/L) for women and ≤ 13 g/dL (130 g/L) for men
  • Cirrhosis
  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: NCT01142700

Locations
United States, California
Local Institution
Coronado, California, United States, 92118
Research And Education, Inc.
San Diego, California, United States, 92105
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Bach And Godofsky Infectious Diseases
Bradenton, Florida, United States, 34209
Orlando Immunology Center
Orlando, Florida, United States, 32803
Vita Medical Center & Research Solutions, Inc.
Tamarac, Florida, United States, 33319
United States, Georgia
Gastrointestinal Specialists Of Georgia Pc
Mareitta, Georgia, United States, 30060
United States, Maryland
Maryland Digestive Disease Research
Laurel, Maryland, United States, 20707
United States, Pennsylvania
Local Institution
Philadelphia, Pennsylvania, United States, 19141
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
United States, Virginia
Liver Institute Of Virginia Bon Secours Health System
Newport News, Virginia, United States, 23602
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01142700     History of Changes
Other Study ID Numbers: AI451-004, 2010-018702-36
Study First Received: June 3, 2010
Last Updated: March 14, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Virus Diseases
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
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 20, 2014