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
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: 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 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: 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
Ribavirin
Peginterferon alfa-2b
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2014