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A Study of BMS-824393 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype I

Primary Purpose

Chronic Hepatitis C Virus Genotype 1

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BMS-824393
BMS-824393
BMS-824393
Placebo
Peginterferon Alpha-2a
Ribavirin
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Virus Genotype 1

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Treatment-naive subjects with genotype 1 chronic HCV
  • HCV RNA ≥ 100,000 IU/mL at screening
  • Seronegative for HIV and HBsAg
  • Liver biopsy within prior 2 years demonstrating no cirrhosis

Exclusion Criteria:

  • Any evidence of liver disease other than hepatitis C
  • Diagnosed or suspected hepatocellular carcinoma
  • Laboratory values: neutrophil count < 1500 cells/μL, platelet count < 90,000/μL; Hemoglobin ≤ 12 g/dL (120g/L) for women and ≤ 13 g/dL (130 g/L) for men
  • Cirrhosis

Sites / Locations

  • Local Institution
  • Research And Education, Inc.
  • Washington Hospital Center
  • Bach And Godofsky Infectious Diseases
  • Orlando Immunology Center
  • Vita Medical Center & Research Solutions, Inc.
  • Gastrointestinal Specialists Of Georgia Pc
  • Maryland Digestive Disease Research
  • Local Institution
  • Baylor University Medical Center
  • Liver Institute Of Virginia Bon Secours Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Other

Arm Label

BMS-824393 (10mg)

BMS-824393 (30 mg)

BMS-824393 (100 mg)

Placebo

Peginterferon alfa-2a plus Ribavirin

Arm Description

Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12

Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12

Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12

Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12

Weeks 13 - 48

Outcomes

Primary Outcome Measures

Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA
Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA

Secondary Outcome Measures

Proportion of subjects with rapid virologic response (RVR), defined as undetectable RNA
Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA
Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable
Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable
Resistant variants associated with virologic failure
Resistant variants associated with virologic failure
Resistant variants associated with virologic failure
Resistant variants associated with virologic failure

Full Information

First Posted
June 3, 2010
Last Updated
March 14, 2011
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01142700
Brief Title
A Study of BMS-824393 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype I
Official Title
A Randomized, Placebo-controlled, Phase 2a Study of BMS-824393 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype I
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Withdrawn
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Based on 12-week on-treatment data, at least 1 dose of BMS-824393 can be identified which is safe, well tolerated, and has sufficient antiviral activity to progress to late stage clinical trials when combined with pegIFNα/RBV for treatment of chronically infected hepatitis C virus genotype 1 treatment-naive subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Virus Genotype 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BMS-824393 (10mg)
Arm Type
Experimental
Arm Description
Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12
Arm Title
BMS-824393 (30 mg)
Arm Type
Experimental
Arm Description
Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12
Arm Title
BMS-824393 (100 mg)
Arm Type
Experimental
Arm Description
Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Plus Peginterferon Alfa-2a and Ribavirin Day 1 - Week 12
Arm Title
Peginterferon alfa-2a plus Ribavirin
Arm Type
Other
Arm Description
Weeks 13 - 48
Intervention Type
Drug
Intervention Name(s)
BMS-824393
Intervention Description
Capsule, Oral, 10 mg, once daily
Intervention Type
Drug
Intervention Name(s)
BMS-824393
Intervention Description
Capsule, Oral, 30 mg, once daily
Intervention Type
Drug
Intervention Name(s)
BMS-824393
Intervention Description
Capsule, Oral, 100 mg, once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsule, Oral, 0 mg, once daily
Intervention Type
Drug
Intervention Name(s)
Peginterferon Alpha-2a
Other Intervention Name(s)
Pegasys
Intervention Description
Syringe, subcutaneous 180 mcg/0.5 mL, weekly
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus
Intervention Description
Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily
Primary Outcome Measure Information:
Title
Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time Frame
Week 4
Title
Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time Frame
Week 12
Title
Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time Frame
Week 24
Title
Safety as measured by the frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time Frame
Week 48
Title
Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA
Time Frame
Week 4
Title
Antiviral activity as determined by the proportion of subjects with extended rapid virologic response (eRVR) defined as undetectable HCV RNA
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Proportion of subjects with rapid virologic response (RVR), defined as undetectable RNA
Time Frame
Week 4
Title
Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA
Time Frame
Week 12
Title
Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable
Time Frame
Week 12 (SVR12)
Title
Proportion of subjects with a sustained virologic response (SVR), defined as HCV RNA undetectable
Time Frame
Week 24 (SVR24)
Title
Resistant variants associated with virologic failure
Time Frame
Week 4
Title
Resistant variants associated with virologic failure
Time Frame
Week 12
Title
Resistant variants associated with virologic failure
Time Frame
Follow up Week 12
Title
Resistant variants associated with virologic failure
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Treatment-naive subjects with genotype 1 chronic HCV HCV RNA ≥ 100,000 IU/mL at screening Seronegative for HIV and HBsAg Liver biopsy within prior 2 years demonstrating no cirrhosis Exclusion Criteria: Any evidence of liver disease other than hepatitis C Diagnosed or suspected hepatocellular carcinoma Laboratory values: neutrophil count < 1500 cells/μL, platelet count < 90,000/μL; Hemoglobin ≤ 12 g/dL (120g/L) for women and ≤ 13 g/dL (130 g/L) for men Cirrhosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Research And Education, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92105
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Bach And Godofsky Infectious Diseases
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Vita Medical Center & Research Solutions, Inc.
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Gastrointestinal Specialists Of Georgia Pc
City
Mareitta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Maryland Digestive Disease Research
City
Laurel
State/Province
Maryland
ZIP/Postal Code
20707
Country
United States
Facility Name
Local Institution
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Liver Institute Of Virginia Bon Secours Health System
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study of BMS-824393 in Combination With Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment Naive Subjects With Chronic Hepatitis C Virus Genotype I

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