Ph IIA Study (SOC +/- NS5B) (HEPCAT)

September 23, 2015 updated by: Bristol-Myers Squibb

A Phase 2A Study of BMS-791325 in Combination With Peg Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve Subjects With Chronic Hepatitis C Virus Genotype 1 Infection

At least 1 dose of BMS-791325 can be identified which is safe, well tolerated, and efficacious when combined with peg-interferon alfa-2a (pegIFNα-2a)/ribavirin (RBV) for the treatment of treatment-naïve, chronically-infected hepatitis C virus (HCV) genotype 1 subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • 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

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Advanced Clinical Research Institute
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Mercy Medical Center
      • Baltimore, Maryland, United States, 21229
        • Digestive Disease Associates, P.A.
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Claudia T. Martorell, Md, Llc
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Charlotte Gastroenterology & Hepatology, PLLC
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Options Health Research, LLC
    • Texas
      • Arlington, Texas, United States, 76012
        • The North Texas Research Institute
      • 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

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 as documented by: positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to Screening, and positive for HCV RNA and anti-HCV antibody at Screening
  • HCV RNA ≥ 10*5* IU/mL at Screening
  • Less than 4 weeks total prior therapy with an IFN formulation (ie, IFNα, pegIFNα-2a), or RBV and no exposure to IFN or RBV within 24 weeks of Randomization
  • Results of a biopsy obtained ≤ 24 months prior to Randomization showing no evidence of cirrhosis
  • Body Mass Index (BMI) of 18 to 35 kg/m², inclusive. BMI = weight (kg)/ [height (m)]² at Screening

Exclusion Criteria:

  • Liver transplant recipients
  • Documented or suspected HCC by imaging or liver biopsy
  • Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
  • History of chronic hepatitis B virus (HBV) as documented by HBV serologies (eg. HBsAg-seropositive). Patients with resolved HBV infection may participate (eg. HBsAb-seropositive)
  • Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment

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
Intervention / Treatment
Experimental: Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin
Drug: BMS-791325
Tablets, Oral, 75 mg, twice daily, 4-48 weeks depending on response
Drug: BMS-791325
Tablets, Oral, 150 mg, twice daily, 4-48 weeks depending on response
Drug: Peg-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response
Other Names:
  • Pegasys
Drug: Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response
Other Names:
  • Copegus
Experimental: Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin
Drug: BMS-791325
Tablets, Oral, 75 mg, twice daily, 4-48 weeks depending on response
Drug: BMS-791325
Tablets, Oral, 150 mg, twice daily, 4-48 weeks depending on response
Drug: Peg-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response
Other Names:
  • Pegasys
Drug: Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response
Other Names:
  • Copegus
Placebo Comparator: Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin
Drug: Peg-interferon alfa-2a
Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response
Other Names:
  • Pegasys
Drug: Ribavirin
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response
Other Names:
  • Copegus
Drug: Placebo
Tablets, Oral, 0 mg, twice daily, 4-48 weeks depending on response

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time Frame: Formal analysis at week 4 (and upon occurrence)
Formal analysis at week 4 (and upon occurrence)
Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time Frame: Formal analysis at week 12 (and upon occurrence)
Formal analysis at week 12 (and upon occurrence)
Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time Frame: Formal analysis at week 24 post treatment (and upon occurrence)
Formal analysis at week 24 post treatment (and upon occurrence)
Safety, as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time Frame: Formal analysis at week 48 post treatment (and upon occurrence)
Formal analysis at week 48 post treatment (and upon occurrence)
Antiviral activity, as determined by the proportion subjects with eRVR
Time Frame: Week 4
Week 4
Antiviral activity, as determined by the proportion subjects with eRVR
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA
Time Frame: Week 12
Week 12
Proportion of subjects with rapid virologic response (RVR), defined as undetectable HCV RNA
Time Frame: Week 4
Week 4
Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up
Time Frame: Week 12
Week 12
Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up
Time Frame: Week 24
Week 24
Resistant HCV variants associated with virologic failure
Time Frame: End of treatment (Week 48) or upon early discontinuation
End of treatment (Week 48) or upon early discontinuation

Collaborators and Investigators

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

Sponsor

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.

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

October 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

August 25, 2010

First Submitted That Met QC Criteria

August 31, 2010

First Posted (Estimate)

September 1, 2010

Study Record Updates

Last Update Posted (Estimate)

October 9, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI443-012

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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