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Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment (HEPCAT)

Primary Purpose

Hepatitis C Virus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-790052
BMS-790052
Placebo
peginterferon 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
  • Non-responder to prior therapy with peginterferon alfa and ribavirin
  • HCV RNA viral load of 100,00 IU/mL
  • Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population)
  • Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma
  • Body Mass Index (BMI) of 18 to 35 kg/m2

Exclusion Criteria:

  • Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening
  • Evidence of medical condition associated with chronic liver disease other than HCV
  • Evidence of decompensated cirrhosis based on radiologic criteria or biopsy

Sites / Locations

  • Alabama Liver & Digestive Specialists (Alds)
  • Scripps Clinic
  • CLI
  • Desta Digestive Disease Medical Center
  • University Of California At San Francisco
  • California Pacific Medical Center
  • Kaiser Permanente Medical Center
  • Transplant Center And Hepatology Clinic, B-154
  • Yale University School Of Medicine
  • University Of Florida Hepatology
  • Miami Research Associates
  • Indiana University
  • Ochsner Clinic Foundation
  • Mercy Medical Center
  • Digestive Disease Associates, P.A.
  • Johns Hopkins Medical Institutions
  • The Research Institute
  • Saint Louis University
  • Samuel S. Stratton Vamc
  • James J Peters Vamc
  • James Sungsik Park, M.D. C.N.S.C.
  • Upper Delaware Valley Infectious Diseases, Pc
  • University Of Rochester Medical Center
  • University Of North Carolina, Chapel Hill
  • Carolinas Center For Liver Disease
  • Healthcare Research Consultants
  • University Of Pennsylvania
  • University Gastroenterology
  • Nashville Medical Research Institute
  • North Texas Research Institute
  • Liver Associates Of Texas
  • St. Luke'S Episcopal Hospital - Baylor College Of Medicine
  • Alamo Medical Research
  • Metropolitan Research
  • Dean Clinic
  • 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
  • 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
  • Instituto De Investigacion Cientifica Del Sur
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin

Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin

Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin

Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin

Arm 5: Placebo plus peginterferon alfa-2a and ribavirin

Arm Description

(prior null responders)

(prior null responders)

(prior partial responders)

(prior partial responders)

(prior partial responders only)

Outcomes

Primary Outcome Measures

Percentage of Participants With Extended Rapid Virologic Response (eRVR)
eRVR was defined as undetectable Hepatitis C virus RNA at both Weeks 4 and 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Percentage of Participants With 24-week Sustained Virologic Response (SVR24)
SVR24 was defined as undetectable RNA (Hepatitis C Virus [HCV] RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; or was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.

Secondary Outcome Measures

Percentage of Participants With Rapid Virologic Response (RVR)
RVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation [LLOQ], target not detected (TND) at Week 4. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
Percentage of Participants With Complete Early Virologic Response (cEVR)
cEVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation [LLOQ], target not detected (TND) at Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)
SVR12 was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.
Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Non-structural protein 5A of HCV resistance associated polymorphisms in GT-1b samples, included L28M/V, R30H/Q, L31M, Q54H/N/Y, P58A/Q/S, Q62E/K/N/R/S, A92T/V and Y93F/H.

Full Information

First Posted
July 16, 2010
Last Updated
September 11, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01170962
Brief Title
Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment
Acronym
HEPCAT
Official Title
A Phase 2B Study of BMS-790052 in Combination With Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who Are Null or Partial Responders to Prior Treatment With Peginterferon Alfa Plus Ribavirin Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
December 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 determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.

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 ProviderInvestigator
Allocation
Randomized
Enrollment
512 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin
Arm Type
Experimental
Arm Description
(prior null responders)
Arm Title
Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin
Arm Type
Experimental
Arm Description
(prior null responders)
Arm Title
Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin
Arm Type
Experimental
Arm Description
(prior partial responders)
Arm Title
Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin
Arm Type
Experimental
Arm Description
(prior partial responders)
Arm Title
Arm 5: Placebo plus peginterferon alfa-2a and ribavirin
Arm Type
Experimental
Arm Description
(prior partial responders only)
Intervention Type
Drug
Intervention Name(s)
BMS-790052
Intervention Description
Film coated tablet, Oral, 20 mg, once daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
BMS-790052
Intervention Description
Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Film coated tablet, Oral, 0mg, Once daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a
Other Intervention Name(s)
Pegasys®
Intervention Description
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
Intervention Type
Drug
Intervention Name(s)
ribavirin
Other Intervention Name(s)
Copegus®
Intervention Description
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Description
eRVR was defined as undetectable Hepatitis C virus RNA at both Weeks 4 and 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Time Frame
Week 4, Week 12
Title
Percentage of Participants With 24-week Sustained Virologic Response (SVR24)
Description
SVR24 was defined as undetectable RNA (Hepatitis C Virus [HCV] RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Time Frame
Follow-up Week 24
Title
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment
Description
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; or was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Time Frame
From first dose to last dose plus 7 days, up to 49 weeks
Title
Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period
Description
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Time Frame
From day 8 post last dose of treatment up-to Week 72
Secondary Outcome Measure Information:
Title
Percentage of Participants With Rapid Virologic Response (RVR)
Description
RVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation [LLOQ], target not detected (TND) at Week 4. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
Time Frame
Week 4
Title
Percentage of Participants With Complete Early Virologic Response (cEVR)
Description
cEVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation [LLOQ], target not detected (TND) at Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
Time Frame
Week 12
Title
Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)
Description
SVR12 was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Time Frame
Follow-up Week 12
Title
Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Description
Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.
Time Frame
Baseline to follow-up Week 48
Title
Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Description
Non-structural protein 5A of HCV resistance associated polymorphisms in GT-1b samples, included L28M/V, R30H/Q, L31M, Q54H/N/Y, P58A/Q/S, Q62E/K/N/R/S, A92T/V and Y93F/H.
Time Frame
Baseline to follow-up Week 48

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 Non-responder to prior therapy with peginterferon alfa and ribavirin HCV RNA viral load of 100,00 IU/mL Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population) Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma Body Mass Index (BMI) of 18 to 35 kg/m2 Exclusion Criteria: Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening Evidence of medical condition associated with chronic liver disease other than HCV Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
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
Alabama Liver & Digestive Specialists (Alds)
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36116
Country
United States
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
CLI
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Desta Digestive Disease Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
University Of California At San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
California Pacific Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Kaiser Permanente Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Transplant Center And Hepatology Clinic, B-154
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Yale University School Of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
University Of Florida Hepatology
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0277
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
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
Johns Hopkins Medical Institutions
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
The Research Institute
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01105
Country
United States
Facility Name
Saint Louis University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Samuel S. Stratton Vamc
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
James J Peters Vamc
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
James Sungsik Park, M.D. C.N.S.C.
City
Great Neck
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Upper Delaware Valley Infectious Diseases, Pc
City
Monticello
State/Province
New York
ZIP/Postal Code
12701
Country
United States
Facility Name
University Of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University Of North Carolina, Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7584
Country
United States
Facility Name
Carolinas Center For Liver Disease
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
Facility Name
Healthcare Research Consultants
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
University Of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University Gastroenterology
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Nashville Medical Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
North Texas Research Institute
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Liver Associates Of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
St. Luke'S Episcopal Hospital - Baylor College Of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
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
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
Ciudad De Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1181ACH
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
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Local Institution
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Local Institution
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution
City
Prahan
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Local Institution
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Local Institution
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Local Institution
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3P9
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Local Institution
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Local Institution
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Local Institution
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Local Institution
City
Clichy Cedex
ZIP/Postal Code
92118
Country
France
Facility Name
Local Institution
City
Creteil Cedex
ZIP/Postal Code
94010
Country
France
Facility Name
Local Institution
City
Lyon Cedex 04
ZIP/Postal Code
69317
Country
France
Facility Name
Local Institution
City
Nice Cedex 03
ZIP/Postal Code
06202
Country
France
Facility Name
Local Institution
City
Paris Cedex 14
ZIP/Postal Code
75679
Country
France
Facility Name
Local Institution
City
Paris Cedex
ZIP/Postal Code
75013
Country
France
Facility Name
Local Institution
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Local Institution
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Local Institution
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Local Institution
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution
City
Cisanello (pisa)
ZIP/Postal Code
56124
Country
Italy
Facility Name
Local Institution
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Local Institution
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62170
Country
Mexico
Facility Name
Local Institution
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64710
Country
Mexico
Facility Name
Instituto De Investigacion Cientifica Del Sur
City
Ponce
ZIP/Postal Code
00780
Country
Puerto Rico
Facility Name
Local Institution
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Local Institution
City
Gothenburg
ZIP/Postal Code
SE-416 85
Country
Sweden
Facility Name
Local Institution
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

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

Learn more about this trial

Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment

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