Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin

September 23, 2015 updated by: Bristol-Myers Squibb

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
285

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1181
        • Local Institution
    • Buenos Aires
      • Ciudad De Buenos Aires, Buenos Aires, Argentina, C1121ABE
        • Local Institution
      • Prov. Buenos Aires, Buenos Aires, Argentina, 1629
        • Local Institution
    • Santa Fe
      • Prov De Santa Fe, Santa Fe, Argentina, 2000
        • Local Institution
  • France
      • Creteil Cedex, France, 94010
        • Local Institution
      • Marseille Cedex 08, France, 13285
        • Local Institution
      • Montpellier Cedex 5, France, 34295
        • Local Instituition
      • Paris Cedex 13, France, 75651
        • Local Institution
      • Paris Cedex 14, France, 75679
        • Local Institution
      • Vandoeuvre Les Nancy, France, 54511
        • Local Institution
  • Germany
      • Frankfurt, Germany, 60590
        • Local Institution
      • Heidelberg, Germany, 69120
        • Local Institution
      • Mainz, Germany, 55131
        • Local Institution
      • Wurzburg, Germany, 97080
        • Local Institution
  • Ireland
      • Dublin, Ireland, DUBLIN 7
        • Local Institution
  • Italy
      • Torino, Italy, 10126
        • Local Institution
  • Spain
      • Alicante, Spain, 03010
        • Local Institution
      • Barcelona, Spain, 08035
        • Local Institution
      • Madrid, Spain, 28222
        • Local Institution
      • Malaga, Spain, 29010
        • Local Institution
      • Valencia, Spain, 46010
        • Local Institution
  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, SE5 9RS
        • Local Institution
      • London, Greater London, United Kingdom, W2 1NY
        • Local Institution
      • London, Greater London, United Kingdom, E1 2AT
        • Local Institution
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M8 5RB
        • Local Institution
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G12 0YN
        • Local Institution
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0006
        • University of Alabama at Birmingham
      • Montgomery, Alabama, United States, 36116
        • Alabama Liver & Digestive Specialists (Alds)
    • Florida
      • Orlando, Florida, United States, 32804
        • Florida Hospital Transplant Center
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
    • Massachusetts
      • Springfield, Massachusetts, United States, 01105
        • The Research Institute
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Medical Center
    • New York
      • Bronx, New York, United States, 10468
        • James J Peters VAMC
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina, Chapel Hill
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135-2920
        • Healthcare Research Consultants
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Science Univ
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Metropolitan Research
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Dean Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Phase 2a: Arm 1
Drug: BMS-650032
Tablets, Oral, 200 mg, Twice Daily, 48 weeks
Drug: BMS-650032
Tablets, Oral, 200 mg, Twice Daily, 12 or 24 weeks, depending on response
Drug: Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
Other Names:
  • Pegasys
Drug: Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 24 or 48 weeks, depending on response
Other Names:
  • Pegasys
Drug: Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
Other Names:
  • Copegus
Drug: Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 24 or 48 weeks depending on response
Other Names:
  • Pegasys
Placebo Comparator: Phase 2a: Arm 2
Drug: Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
Other Names:
  • Pegasys
Drug: Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 24 or 48 weeks, depending on response
Other Names:
  • Pegasys
Drug: Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
Other Names:
  • Copegus
Drug: Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 24 or 48 weeks depending on response
Other Names:
  • Pegasys
Drug: Placebo
Tablets, Oral, 0 mg, twice daily, 48 weeks
Other Names:
  • Pegasys
Drug: Placebo
Tablets, Oral, 0 mg, twice daily, 0 or 12 weeks (depending on response) beginning at Week 12
Drug: Placebo
Tablets, Oral, 0 mg, twice daily 24 weeks
Experimental: Phase 2b: Arm 1
Drug: BMS-650032
Tablets, Oral, 200 mg, Twice Daily, 48 weeks
Drug: BMS-650032
Tablets, Oral, 200 mg, Twice Daily, 12 or 24 weeks, depending on response
Drug: Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
Other Names:
  • Pegasys
Drug: Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 24 or 48 weeks, depending on response
Other Names:
  • Pegasys
Drug: Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
Other Names:
  • Copegus
Drug: Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 24 or 48 weeks depending on response
Other Names:
  • Pegasys
Drug: Placebo
Tablets, Oral, 0 mg, twice daily, 48 weeks
Other Names:
  • Pegasys
Drug: Placebo
Tablets, Oral, 0 mg, twice daily, 0 or 12 weeks (depending on response) beginning at Week 12
Drug: Placebo
Tablets, Oral, 0 mg, twice daily 24 weeks
Placebo Comparator: Phase 2b: Arm 2
Drug: Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
Other Names:
  • Pegasys
Drug: Peginterferon Alfa-2a
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 24 or 48 weeks, depending on response
Other Names:
  • Pegasys
Drug: Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
Other Names:
  • Copegus
Drug: Ribavirin
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 24 or 48 weeks depending on response
Other Names:
  • Pegasys
Drug: Placebo
Tablets, Oral, 0 mg, twice daily, 48 weeks
Other Names:
  • Pegasys
Drug: Placebo
Tablets, Oral, 0 mg, twice daily, 0 or 12 weeks (depending on response) beginning at Week 12
Drug: Placebo
Tablets, Oral, 0 mg, twice daily 24 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
12 weeks after first dose
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
Week 4
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
Week 12
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
at follow-up Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of HCV genotype 1 subjects with rapid virologic response (RVR), defined as undetectable HCV RNA at Week 4
Time Frame: Week 4
Week 4
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)
at Week 12 (Stage 2 only)
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)
Week 12 (Stage 1 only)
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
follow-up Week 12
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)
follow-up Week 24 (Stage 1 only)
Resistant variants associated with virologic failure
Time Frame: 48 weeks after last dose
48 weeks after last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AI447-016
  • 2009-013652-69 (Registry Identifier: EUDRACT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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