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

Primary Purpose

Hepatitis C Virus

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BMS-791325
BMS-791325
Placebo
Peg-interferon alfa-2a
Ribavirin
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C Virus

Eligibility Criteria

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

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

Sites / Locations

  • Advanced Clinical Research Institute
  • Loyola University Medical Center
  • Mercy Medical Center
  • Digestive Disease Associates, P.A.
  • Claudia T. Martorell, Md, Llc
  • Charlotte Gastroenterology & Hepatology, Pllc
  • Options Health Research, Llc
  • The North Texas Research Institute
  • Alamo Medical Research
  • Metropolitan Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin

Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin

Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin

Arm Description

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 subjects with eRVR
Antiviral activity, as determined by the proportion subjects with eRVR

Secondary Outcome Measures

Proportion of subjects with rapid virologic response (RVR), defined as undetectable HCV RNA
Proportion of subjects with complete early virologic response (cEVR), defined as undetectable HCV RNA
Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up
Proportions of subjects with a 12-week SVR (SVR12) and 24-week SVR (SVR24), defined as undetectable HCV RNA at off treatment follow-up
Resistant HCV variants associated with virologic failure

Full Information

First Posted
August 25, 2010
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01193361
Brief Title
Ph IIA Study (SOC +/- NS5B)
Acronym
HEPCAT
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 - BMS-791325 plus peg-interferon alfa-2a and ribavirin
Arm Type
Experimental
Arm Title
Arm 2 - BMS-791325 plus peg-interferon alfa-2a and ribavirin
Arm Type
Experimental
Arm Title
Arm 3 - Placebo plus peg-interferon alfa-2a and ribavirin
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-791325
Intervention Description
Tablets, Oral, 75 mg, twice daily, 4-48 weeks depending on response
Intervention Type
Drug
Intervention Name(s)
BMS-791325
Intervention Description
Tablets, Oral, 150 mg, twice daily, 4-48 weeks depending on response
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, 0 mg, twice daily, 4-48 weeks depending on response
Intervention Type
Drug
Intervention Name(s)
Peg-interferon alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus
Intervention Description
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response
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
Formal analysis at week 4 (and upon occurrence)
Title
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)
Title
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)
Title
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)
Title
Antiviral activity, as determined by the proportion subjects with eRVR
Time Frame
Week 4
Title
Antiviral activity, as determined by the proportion subjects with eRVR
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Proportion of subjects with rapid virologic response (RVR), defined as undetectable HCV 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
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
Title
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
Title
Resistant HCV variants associated with virologic failure
Time Frame
End of treatment (Week 48) or upon early discontinuation

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: 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
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
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Digestive Disease Associates, P.A.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Claudia T. Martorell, Md, Llc
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Charlotte Gastroenterology & Hepatology, Pllc
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Options Health Research, Llc
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
The North Texas Research Institute
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Metropolitan Research
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

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Ph IIA Study (SOC +/- NS5B)

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