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

  Show 40 Study Locations
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 April 14, 2014