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Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients (HEPCAT)

Primary Purpose

Hepatitis C Virus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Daclatasvir
Daclatasvir
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:

  • Patients chronically infected with hepatitis C virus (HCV) genotype 1 or 4
  • HCV RNA viral load of ≥100,000 IU/mL
  • No previous exposure to interferon, pegIFNα, or RBV
  • Results of a liver biopsy demonstrating absence of cirrhosis obtained ≤24 months prior to randomization. Compensated cirrhotics with Hepatitis C virus genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
  • Findings on ultrasound, computed tomography scan, or magnetic resonance imaging 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
  • Body mass index of 18 to 35 kg/m^2

Exclusion Criteria:

  • Positive for hepatitis B or HIV-1/HIV-2 antibody at screening
  • Evidence of a 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, San Francisco/Sf General Hospital
  • California Pacific Medical Center
  • Kaiser Permanente Medical Center
  • Transplant Center And Hepatology Clinic, B-154
  • Yale University School Of Medicine
  • University Of Florida Hepatology
  • University Of Miami
  • Miami Research Associates
  • Indiana University
  • Ochsner Clinic Foundation
  • Mercy Medical Center
  • Digestive Disease Associates, P.A.
  • Johns Hopkins University
  • Claudia T. Martorell, Md, Llc
  • James J Peters Vamc
  • James Sungsik Park, M.D. C.N.S.C.
  • Upper Delaware Valley Infectious Diseases, Pc
  • University Of North Carolina At Chapel Hill School Of Med
  • Carolinas Center For Liver Disease
  • Options Health Research, Llc
  • Healthcare Research Consultants
  • University Of Pennsylvania
  • University Gastroenterology
  • Nashville Medical Research Institute
  • North Texas Research Institute
  • 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 Instituition
  • 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 Type

Experimental

Experimental

Placebo Comparator

Arm Label

Daclatasvir plus peg-interferon alfa-2a and ribavirin (20 mg)

Daclatasvir plus peg-interferon alfa-2a and ribavirin (60 mg)

Placebo plus peg-interferon alfa-2a and ribavirin

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR)
eRVR was defined as HCV RNA <lower limit of quantitation and target not detected at both Weeks 4 and 12 on treatment.
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24)
SVR24 was defined as HCV <lower limit of quantitation (LLOQ) and target not detected (TND) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, 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
SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.

Secondary Outcome Measures

Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR)
RVR was defined as undetectable RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 4. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR)
cEVR was defined as undetectable RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12)
SVR12 was defined as undetectable RNA (HCV RNA < lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
Percentage of Resistant Variants Associated With Virologic Failure
Virologic failure was defined as: Virologic breakthrough: confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA <LLOQ, target not detected (TND) while on treatment <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment HCV RNA < LLOQ, TD or ≥ LLOQ at Week 12 and ≥ LLOQ at Week 24 HCV RNA ≥LLOQ or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation) Relapse, defined as HCV RNA ≥LLOQ or <LLOQ, TD during follow-up, after HCV RNA < LLOQ, TND at EOT. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.

Full Information

First Posted
May 17, 2010
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01125189
Brief Title
Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients
Acronym
HEPCAT
Official Title
A Phase 2b Study of Daclatasvir in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
August 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
To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.

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
558 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daclatasvir plus peg-interferon alfa-2a and ribavirin (20 mg)
Arm Type
Experimental
Arm Title
Daclatasvir plus peg-interferon alfa-2a and ribavirin (60 mg)
Arm Type
Experimental
Arm Title
Placebo plus peg-interferon alfa-2a and ribavirin
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Daclatasvir
Intervention Description
Tablets, oral, 20 mg, once daily, 12-24 weeks, depending on response
Intervention Type
Drug
Intervention Name(s)
Daclatasvir
Intervention Description
Tablets, oral, 60 mg, once daily, 12-24 weeks, depending on response
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets, oral, 0 mg, once daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
peg-interferon alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
Syringe, subcutaneous Injection, 180 µg, once weekly, 24 or 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, once daily, 24 or 48 weeks depending on response
Primary Outcome Measure Information:
Title
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Extended Rapid Virologic Response (eRVR)
Description
eRVR was defined as HCV RNA <lower limit of quantitation and target not detected at both Weeks 4 and 12 on treatment.
Time Frame
Weeks 4 and 12
Title
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Sustained Virologic Response (SVR24)
Description
SVR24 was defined as HCV <lower limit of quantitation (LLOQ) and target not detected (TND) at follow-up Week 24. The LLOQ was 25 IU/mL, and <LLOQ, 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
Description
SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Time Frame
From start of study treatment (day 1) up to follow-up Week 48
Secondary Outcome Measure Information:
Title
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Rapid Virologic Response (RVR)
Description
RVR was defined as undetectable RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 4. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
Time Frame
Week 4
Title
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With Complete Early Virologic Response (cEVR)
Description
cEVR was defined as undetectable RNA (HCV RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
Time Frame
Week 12
Title
Percentage of Hepatitis C Virus (HCV) Genotype 1 Participants With 12-week Sustained Virologic Response (SVR12)
Description
SVR12 was defined as undetectable RNA (HCV RNA < lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
Time Frame
Follow-up Week 12
Title
Percentage of Resistant Variants Associated With Virologic Failure
Description
Virologic failure was defined as: Virologic breakthrough: confirmed >1 log10 increase in hepatitis C virus (HCV) RNA over nadir or confirmed RNA ≥lower limit of quantitation (LLOQ) after confirmed HCV RNA <LLOQ, target not detected (TND) while on treatment <1 log10 decrease in HCV RNA from baseline at Week 4 of treatment Failure to achieve early virologic response: <2 log10 decrease in HCV RNA from baseline and HCV RNA ≥LLOQ at Week 12 of treatment HCV RNA < LLOQ, TD or ≥ LLOQ at Week 12 and ≥ LLOQ at Week 24 HCV RNA ≥LLOQ or <LLOQ, target detected (TD) at the end of treatment (EOT) (including early discontinuation) Relapse, defined as HCV RNA ≥LLOQ or <LLOQ, TD during follow-up, after HCV RNA < LLOQ, TND at EOT. The LLOQ was 25 IU/mL, and <LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. N=Number of participants analyzed for this outcome.
Time Frame
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: Patients chronically infected with hepatitis C virus (HCV) genotype 1 or 4 HCV RNA viral load of ≥100,000 IU/mL No previous exposure to interferon, pegIFNα, or RBV Results of a liver biopsy demonstrating absence of cirrhosis obtained ≤24 months prior to randomization. Compensated cirrhotics with Hepatitis C virus genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization) Findings on ultrasound, computed tomography scan, or magnetic resonance imaging 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma Body mass index of 18 to 35 kg/m^2 Exclusion Criteria: Positive for hepatitis B or HIV-1/HIV-2 antibody at screening Evidence of a 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, San Francisco/Sf General Hospital
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
Country
United States
Facility Name
University Of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
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 University
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Claudia T. Martorell, Md, Llc
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01105
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 North Carolina At Chapel Hill School Of Med
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
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
Options Health Research, Llc
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
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
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
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Local Institution
City
Westmead Nsw
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Local Institution
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Local Institution
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution
City
Clayton Vic
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Local Institution
City
Camperdown
ZIP/Postal Code
NSW 2050
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
Shebin Elkom
State/Province
Menoufiya
ZIP/Postal Code
35111
Country
Egypt
Facility Name
Local Institution
City
Cairo
ZIP/Postal Code
11559
Country
Egypt
Facility Name
Local Institution
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Local Institution
City
Marseille Cedex 08
ZIP/Postal Code
13285
Country
France
Facility Name
Local Institution
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Local Instituition
City
Paris Cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
Local Institution
City
Paris Cedex 14
ZIP/Postal Code
75679
Country
France
Facility Name
Local Institution
City
Duesseldorf
ZIP/Postal Code
40237
Country
Germany
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
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
44340
Country
Mexico
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
141 86
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
25080450
Citation
Hezode C, Hirschfield GM, Ghesquiere W, Sievert W, Rodriguez-Torres M, Shafran SD, Thuluvath PJ, Tatum HA, Waked I, Esmat G, Lawitz EJ, Rustgi VK, Pol S, Weis N, Pockros PJ, Bourliere M, Serfaty L, Vierling JM, Fried MW, Weiland O, Brunetto MR, Everson GT, Zeuzem S, Kwo PY, Sulkowski M, Brau N, Hernandez D, McPhee F, Wind-Rotolo M, Liu Z, Noviello S, Hughes EA, Yin PD, Schnittman S. Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: a randomised study. Gut. 2015 Jun;64(6):948-56. doi: 10.1136/gutjnl-2014-307498. Epub 2014 Jul 30.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

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Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients

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