Study to Determine the Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Who Have Previously Failed Standard of Care

September 23, 2015 updated by: Bristol-Myers Squibb

Parallel, Open-Label, Randomized, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-790052 and BMS-650032 in Combination in Null Responders to Standard of Care Infected With Chronic Hepatitis C Virus Genotype 1

The purpose of this study is to determine whether BMS-650032 and BMS-790052 in combination alone, together with Ribavirin, or together with Interferon and Ribavirin are effective in the treatment of Hepatitis C in patients who have not responded to prior therapy.

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.
215

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

  • France
      • Clichy Cedex, France, 92118
        • Local Institution
      • Creteil Cedex, France, 94010
        • Local Institution
      • Marseille Cedex 08, France, 13285
        • Local Institution
      • Paris Cedex 12, France, 75571
        • Local Institution
      • Paris Cedex 13, France, 75651
        • Local Institution
      • Paris Cedex 14, France, 75679
        • Local Institution
      • Pessac, France, 33604
        • Local Institution
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Local Institution
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Advanced Clinical Research Institute
      • Coronado, California, United States, 92118
        • Southern California Liver Centers
      • San Jose, California, United States, 95128
        • San Jose Gastroenterology
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University Of Colorado Denver & Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System
    • North Carolina
      • Statesville, North Carolina, United States, 28677
        • Carolinas Center For Liver Disease
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute, LLC
      • San Antonio, Texas, United States, 78215
        • Alamo Medical Research
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Metropolitan Research

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:

  • Male and female subjects ages 18 to 70 years
  • HCV-Infected Genotype 1 Null responders to current standard of care
  • Expansion Cohorts A1 and A2 are restricted to patients infected with HCV Genotype 1b only.

Exclusion Criteria:

  • Evidence of a medical condition associate with chronic liver disease other than HCV
  • History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
  • History of Cancer within 5 years of enrollment
  • History of gastrointestinal disease or surgical procedure (except Cholecystectomy)
  • History of clinically significant cardiac disease
  • History of Glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Documented cirrhosis within 12 months prior to dosing
  • Positive for Human Immunodeficiency Virus (HIV) or Hepatitis B Virus (HBV)
  • Pregnant

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: None (Open Label)

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: Arm 1: Sentinel A
BMS-790052 (60mg) once daily + BMS-650032 (600 mg) twice daily
Drug: BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 600 mg, twice daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 200mg, twice daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 200 mg, once daily, 24 weeks
Experimental: Arm 2: Sentinel B
BMS-790052 (60mg) once daily + BMS-650032 (600mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
Drug: BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 600 mg, twice daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 200mg, twice daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 200 mg, once daily, 24 weeks
Drug: Pegylated-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly
Other Names:
  • Pegasys
Drug: Ribavirin

Tablets, Oral

For subjects weighing < 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg

Twice daily (< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks

Other Names:
  • Copegus
Experimental: Arm 3: Expansion A1
BMS-790052 (60mg) once daily + BMS-650032 (200mg) twice daily
Drug: BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 600 mg, twice daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 200mg, twice daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 200 mg, once daily, 24 weeks
Experimental: Arm 4: Expansion A2
BMS-790052 (60mg) once daily + BMS-650032 (200mg) once daily
Drug: BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 600 mg, twice daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 200mg, twice daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 200 mg, once daily, 24 weeks
Experimental: Arm 5: Expansion B1
BMS-790052 (60mg) once daily + BMS-650032 (200 mg) twice daily + Pegylated-interferon alfa-2a + Ribavirin
Drug: BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 600 mg, twice daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 200mg, twice daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 200 mg, once daily, 24 weeks
Drug: Pegylated-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly
Other Names:
  • Pegasys
Drug: Ribavirin

Tablets, Oral

For subjects weighing < 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg

Twice daily (< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks

Other Names:
  • Copegus
Experimental: Arm 6: Expansion B2
BMS-790052 (60mg) once daily + BMS-650032 (200 mg) once daily + Pegylated-interferon alfa-2a + Ribavirin
Drug: BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 600 mg, twice daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 200mg, twice daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 200 mg, once daily, 24 weeks
Drug: Pegylated-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly
Other Names:
  • Pegasys
Drug: Ribavirin

Tablets, Oral

For subjects weighing < 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg

Twice daily (< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks

Other Names:
  • Copegus
Experimental: Arm 7: Expansion B3
BMS-790052 (60 mg) once daily + BMS-650032 (200 mg) twice daily + Ribavirin
Drug: BMS-790052
Tablets, Oral, 60 mg, once daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 600 mg, twice daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 200mg, twice daily, 24 weeks
Drug: BMS-650032
Tablets, Oral, 200 mg, once daily, 24 weeks
Drug: Ribavirin

Tablets, Oral

For subjects weighing < 75 kg: 1000 mg; For subjects weighing ≥ 75 kg: 1200 mg

Twice daily (< 75 kg: 400 mg in ante meridian (AM) and 600 mg in post meridian (PM); ≥ 75 kg: 600 mg in AM and PM), 24 weeks

Other Names:
  • Copegus

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
Hepatitis C virus (HCV) ribonucleic acid (RNA) levels in subjects' blood before, during and after treatment
Time Frame: 12 weeks post treatment
12 weeks post treatment

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
Measure Description
Time Frame
Safety assessments will be based on medical review of the frequency of SAEs and AEs, discontinuations due to AEs, and abnormalities observed from vital sign and ECG measurements, physical examinations and clinical laboratory results
Time Frame: 12 weeks post-treatment
Serious Adverse Events (SAEs), Adverse Events (AEs), Electrocardiogram (ECG)
12 weeks post-treatment
Pharmacokinetic parameter maximum observed concentration [Cmax] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected.
Time Frame: Day 1 and Day 14
Day 1 and Day 14
Pharmacokinetic parameter trough observed concentration [Cmin] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected.
Time Frame: Days 1, Days 7, Days 14, Weeks 4, Weeks 8, Weeks 12, Weeks 16
Days 1, Days 7, Days 14, Weeks 4, Weeks 8, Weeks 12, Weeks 16
Pharmacokinetic parameter time of maximum observed concentration [Tmax] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected.
Time Frame: Day 1 and Day 14
Day 1 and Day 14
Pharmacokinetic parameter area under the concentration-time curve in one dosing interval [AUC(TAU)] will be derived from plasma concentration versus time. Trough concentration (Ctrough) and sparse Pharmacokinetics (PK) samples will also be collected.
Time Frame: Day 1 and Day 14
Day 1 and Day 14

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.
December 1, 2009

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.
February 1, 2014

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).
November 12, 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.
November 12, 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.
November 13, 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.
  • AI447-011
  • 2010-024637-23 (EudraCT Number)

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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