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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01017575
First received: November 19, 2009
Last updated: November 29, 2011
Last verified: June 2010
  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 Infection
Drug: BMS-790052
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 Study of BMS-790052 in Combination With Peginterferon Alfa-2a(Pegasys®) and Ribavirin (Copegus®) 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: Week 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 ]

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: 43
Study Start Date: December 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A (BMS-790052, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
Drug: BMS-790052
Tablets, Oral, 10 mg, daily, 24-48 weeks
Drug: Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Name: Pegasys®
Drug: Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Name: Copegus®
Experimental: Arm B (BMS-790052, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
Drug: BMS-790052
Tablets, Oral, 60 mg, daily, 24-48 weeks
Drug: Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Name: Pegasys®
Drug: Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Name: Copegus®
Placebo Comparator: Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
Drug: Placebo
Tablets, Oral, 0 mg, daily, 48 weeks
Drug: Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Name: Pegasys®
Drug: Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Name: Copegus®
Experimental: Arm D (BMS-790052, plus peginterferon alfa-2a, Ribavirin)
Non-Responder
Drug: BMS-790052
Tablets, Oral, 10 mg, daily, 24-48 weeks
Drug: Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Name: Pegasys®
Drug: Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Name: Copegus®
Experimental: Arm E (BMS-790052, plus Peginterferon alfa-2a, Ribavirin)
Non-Responder
Drug: BMS-790052
Tablets, Oral, 60 mg, daily, 24-48 weeks
Drug: Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Other Name: Pegasys®
Drug: Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Name: Copegus®

  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: NCT01017575

Locations
Japan
Local Institution
Chiba-Shi, Chiba, Japan
Local Institution
Kurume-Shi, Fukuoka, Japan, 8300011
Local Institution
Okayama-Shi, Okayama, Japan, 7008558
Local Institution
Osaka-Shi, Osaka, Japan, 545-8586
Local Institution
Osaka-Shi, Osaka, Japan, 5438555
Local Institution
Musashino-Shi, Tokyo, Japan, 180-0023
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: NCT01017575     History of Changes
Other Study ID Numbers: AI444-022
Study First Received: November 19, 2009
Last Updated: November 29, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on November 20, 2014