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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
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: 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
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Chronic
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 25, 2014