Safety and Efficacy of BMS-790052 Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2b and Ribavirin)

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01016912
First received: November 19, 2009
Last updated: January 24, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to identify at least 1 dose of BMS-790052, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious


Condition Intervention Phase
Hepatitis C
Drug: BMS-790052
Drug: Placebo
Drug: Peginterferon alfa-2b
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-2b (PegIntron®) and Ribavirin (Rebetol®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Safety and tolerability, as measured by the frequency of SAEs, discontinuations due to AEs, and Grade 3 - 4 laboratory abnormalities [ Time Frame: Weeks 4 ] [ Designated as safety issue: Yes ]
  • Safety and tolerability, as measured by the frequency of SAEs, discontinuations due to 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 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 HCV RNA [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA from baseline [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Proportions of subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Proportions of subjects with 24-week sustained virologic response (SVR24), defined as undetectable HCV RNA [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]
  • Resistant variants associated with virologic failure [ Time Frame: Week 4 ] [ Designated as safety issue: Yes ]
  • Resistant variants associated with virologic failure [ Time Frame: Week 12 ] [ Designated as safety issue: Yes ]
  • Resistant variants associated with virologic failure [ Time Frame: Week 24 ] [ Designated as safety issue: Yes ]

Enrollment: 45
Study Start Date: December 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
Drug: BMS-790052
Tablets, Oral, 10 mg, daily, 24-48 weeks
Drug: Peginterferon alfa-2b
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Name: PegIntron®
Drug: Ribavirin
Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Name: Rebetol®
Experimental: Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
Drug: BMS-790052
Tablets, Oral, 60 mg, daily, 24-48 weeks
Drug: Peginterferon alfa-2b
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Name: PegIntron®
Drug: Ribavirin
Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Name: Rebetol®
Placebo Comparator: Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
Drug: Placebo
Tablets, Oral, 0 mg, daily, 48 weeks
Drug: Peginterferon alfa-2b
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Name: PegIntron®
Drug: Ribavirin
Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Name: Rebetol®
Experimental: Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)
Non-Responder
Drug: BMS-790052
Tablets, Oral, 10 mg, daily, 24-48 weeks
Drug: Peginterferon alfa-2b
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Name: PegIntron®
Drug: Ribavirin
Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Name: Rebetol®
Experimental: Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Non-Responder
Drug: BMS-790052
Tablets, Oral, 60 mg, daily, 24-48 weeks
Drug: Peginterferon alfa-2b
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Name: PegIntron®
Drug: Ribavirin
Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Name: Rebetol®

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects chronically infected with HCV genotype 1
  • HCV RNA viral load ≥ 10*5* IU/mL (100,000 IU/mL) at screening
  • The current standard of care naïve or non-responder

Exclusion Criteria:

  • Cirrhosis
  • HCC
  • Co-infection with HBV, HIV-1 or HIV-2
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016912

Locations
Japan
Local Institution
Hiroshima City, Hiroshima, Japan, 734-0037
Local Institution
Sapporo-Shi, Hokkaido, Japan, 060-0033
Local Institution
Kawasaki-Shi, Kanagawa, Japan, 2138587
Local Institution
Suita-Shi, Osaka, Japan, 5650871
Local Institution
Iruma-Gun, Saitama, Japan, 3500495
Local Institution
Minato-Ku, Tokyo, Japan, 105-0001
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: NCT01016912     History of Changes
Other Study ID Numbers: AI444-021
Study First Received: November 19, 2009
Last Updated: January 24, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

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-2b
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