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

Primary Purpose

Hepatitis C Virus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-650032
BMS-650032
Placebo
Placebo
Placebo
Peginterferon Alfa-2a
Peginterferon Alfa-2a
Ribavirin
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 (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

Sites / Locations

  • University Of Alabama At Birmingham
  • Alabama Liver & Digestive Specialists (Alds)
  • Florida Hospital Transplant Center
  • Mercy Medical Center
  • The Research Institute
  • Umass Memorial Medical Center
  • James J Peters Vamc
  • University Of North Carolina, Chapel Hill
  • Healthcare Research Consultants
  • Oregon Health Science Univ
  • Hospital Of The University Of Pennsylvania
  • Gastro One
  • Metropolitan Research
  • Dean Clinic
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Instituition
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Phase 2a: Arm 1

Phase 2a: Arm 2

Phase 2b: Arm 1

Phase 2b: Arm 2

Arm Description

Outcomes

Primary Outcome Measures

Phase 2a and Phase 2b: Safety, as measured by the frequency of SAEs and discontinuations due to AEs
Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA
Antiviral activity as determined by proportion of HCV genotype 1 subjects with extended rapid virologic response (eRVR), defined as undetectable HCV RNA
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

Secondary Outcome Measures

Proportion of HCV genotype 1 subjects with rapid virologic response (RVR), defined as undetectable HCV RNA at 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)
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)
Proportion of HCV genotype 1 subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA at 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)
Resistant variants associated with virologic failure

Full Information

First Posted
December 10, 2009
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01030432
Brief Title
Study of BMS-650032 With Peginterferon Alfa-2a Plus Ribavirin
Official Title
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
Study Type
Interventional

2. Study Status

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

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
285 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase 2a: Arm 1
Arm Type
Experimental
Arm Title
Phase 2a: Arm 2
Arm Type
Placebo Comparator
Arm Title
Phase 2b: Arm 1
Arm Type
Experimental
Arm Title
Phase 2b: Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-650032
Intervention Description
Tablets, Oral, 200 mg, Twice Daily, 48 weeks
Intervention Type
Drug
Intervention Name(s)
BMS-650032
Intervention Description
Tablets, Oral, 200 mg, Twice Daily, 12 or 24 weeks, depending on response
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Pegasys
Intervention Description
Tablets, Oral, 0 mg, twice daily, 48 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, 0 mg, twice daily, 0 or 12 weeks (depending on response) beginning at Week 12
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, Oral, 0 mg, twice daily 24 weeks
Intervention Type
Drug
Intervention Name(s)
Peginterferon Alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 48 weeks
Intervention Type
Drug
Intervention Name(s)
Peginterferon Alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
Syringe, Subcutaneous injection, 180 mcg / 0.5 mL, Weekly, 24 or 48 weeks, depending on response
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus
Intervention Description
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 48 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Pegasys
Intervention Description
Tablet, Oral, 500 or 600 mg based on weight, Twice Daily, 24 or 48 weeks depending on response
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Proportion of HCV genotype 1 subjects with rapid virologic response (RVR), defined as undetectable HCV RNA at Week 4
Time Frame
Week 4
Title
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)
Title
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)
Title
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
Title
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)
Title
Resistant variants associated with virologic failure
Time Frame
48 weeks after last dose

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
25038486
Citation
Bronowicki JP, Ratziu V, Gadano A, Thuluvath PJ, Bessone F, Martorell CT, Pol S, Terg R, Younes Z, He B, Eley T, Cohen D, Yu F, Hernandez D, McPhee F, Mendez P, Hughes E. Randomized trial of asunaprevir plus peginterferon alfa and ribavirin for previously untreated genotype 1 or 4 chronic hepatitis C. J Hepatol. 2014 Dec;61(6):1220-7. doi: 10.1016/j.jhep.2014.07.011. Epub 2014 Jul 16.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

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

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