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Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3 (PRINCIPAL)

Primary Purpose

Hepatitis C Virus (HCV)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pegylated interferon lambda (pegIFNλ)
Pegylated interferon lambda (pegIFNλ)
Pegylated interferon alfa-2a (pegIFNα-2a)
Ribavirin
Ribavirin
Daclatasvir
Placebo matching Daclatasvir
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 (HCV)

Eligibility Criteria

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Chronic hepatitis C, Genotype 2 or 3
  • Naïve to prior anti-HCV therapy

Exclusion Criteria:

  • Infected with HCV other than Genotype 2 or 3
  • Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening
  • Evidence of liver disease other than HCV
  • Active substance abuse
  • Evidence of decompensated cirrhosis

Sites / Locations

  • Mayo Clinic Arizona
  • Precision Research Institute, Llc
  • Medical Associates Research Group
  • University Of California, San Francisco/Sf General Hospital
  • Kaiser Permanente Medical Center
  • Yale University School Of Medicine
  • Orlando Immunology Center
  • Orlando Infectious Disease Center
  • Gastrointestinal Specialists Of Georgia
  • The Queen'S Liver Center
  • Henry Ford Hospital
  • Carolinas Medical Center
  • Consultants For Clinical Research
  • Healthcare Research Consultants
  • University Of Pittsburgh Medical Center, Ctr For Liver Diseases
  • Texas Clinical Research Institute, Llc
  • St. Luke'S Episcopal Hospital - Baylor College Of Medicine
  • Clinical Research Centers Of America
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir

Arm 2: pegIFNλ + Ribavirin + Daclatasvir

Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir

Arm Description

Outcomes

Primary Outcome Measures

Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12)

Secondary Outcome Measures

Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)]
Proportion of subjects with treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, neutropenia as defined by ANC < 750 mm3 or thrombocytopenia as defined by platelets < 50,000 mm3)
Hb = Hemoglobin ANC = Absolute neutrophil count
Proportion of subjects with on-treatment interferon-associated flu-like symptoms (as defined by pyrexia or chills or pain)
Proportion of subjects with on-treatment musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain)
Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group
Proportion of subjects with on-treatment Serious adverse events (SAEs)
Proportion of subjects with dose reductions
Proportion of subjects who discontinue due to Adverse events (AEs)
Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection
Proportion of subjects with on-treatment constitutional symptoms (fatigue or asthenia)

Full Information

First Posted
June 7, 2012
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01616524
Brief Title
Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3
Acronym
PRINCIPAL
Official Title
A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, With and Without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naïve Genotype 2 and 3 Chronic Hepatitis C Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
September 2014 (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 if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
880 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir
Arm Type
Experimental
Arm Title
Arm 2: pegIFNλ + Ribavirin + Daclatasvir
Arm Type
Experimental
Arm Title
Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Pegylated interferon lambda (pegIFNλ)
Other Intervention Name(s)
BMS-914143
Intervention Description
Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
Intervention Type
Biological
Intervention Name(s)
Pegylated interferon lambda (pegIFNλ)
Other Intervention Name(s)
BMS-914143
Intervention Description
Syringe, Subcutaneous, 180 μg, Once weekly, 12 weeks
Intervention Type
Biological
Intervention Name(s)
Pegylated interferon alfa-2a (pegIFNα-2a)
Other Intervention Name(s)
Pegasys
Intervention Description
Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Ribasphere
Intervention Description
Tablets, Oral, 400 mg, Twice daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Ribasphere
Intervention Description
Tablets, Oral, 400 mg, Twice daily, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Daclatasvir
Other Intervention Name(s)
BMS-790052
Intervention Description
Tablets, Oral, 60 mg, Once daily, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo matching Daclatasvir
Intervention Description
Tablets, Oral, 0 mg, Once daily, 12 weeks
Primary Outcome Measure Information:
Title
Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12)
Time Frame
Post-treatment follow-up week 12
Secondary Outcome Measure Information:
Title
Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)]
Time Frame
On-treatment Week 4
Title
Proportion of subjects with treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, neutropenia as defined by ANC < 750 mm3 or thrombocytopenia as defined by platelets < 50,000 mm3)
Description
Hb = Hemoglobin ANC = Absolute neutrophil count
Time Frame
Up to week 12 or week 24
Title
Proportion of subjects with on-treatment interferon-associated flu-like symptoms (as defined by pyrexia or chills or pain)
Time Frame
Up to week 12 or week 24
Title
Proportion of subjects with on-treatment musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain)
Time Frame
Up to week 12 or week 24
Title
Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group
Time Frame
Post-treatment week 24
Title
Proportion of subjects with on-treatment Serious adverse events (SAEs)
Time Frame
Up to week 12 or week 24
Title
Proportion of subjects with dose reductions
Time Frame
Up to week 12 or week 24
Title
Proportion of subjects who discontinue due to Adverse events (AEs)
Time Frame
Up to week 12 or week 24
Title
Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection
Time Frame
Post-treatment follow-up week 12
Title
Proportion of subjects with on-treatment constitutional symptoms (fatigue or asthenia)
Time Frame
Up to week 12 or week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Chronic hepatitis C, Genotype 2 or 3 Naïve to prior anti-HCV therapy Exclusion Criteria: Infected with HCV other than Genotype 2 or 3 Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening Evidence of liver disease other than HCV Active substance abuse Evidence of decompensated 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
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Precision Research Institute, Llc
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
Medical Associates Research Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
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
Kaiser Permanente Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Yale University School Of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Orlando Infectious Disease Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Gastrointestinal Specialists Of Georgia
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
The Queen'S Liver Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Consultants For Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Healthcare Research Consultants
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
University Of Pittsburgh Medical Center, Ctr For Liver Diseases
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Texas Clinical Research Institute, Llc
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
Clinical Research Centers Of America
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Local Institution
City
Autonoma
State/Province
Buenos Aires
ZIP/Postal Code
C1119ACN
Country
Argentina
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
Mar Del Plata
State/Province
Buenos Aires
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Local Institution
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
B1878DVB
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
C1280AEB
Country
Argentina
Facility Name
Local Institution
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Facility Name
Local Institution
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Local Institution
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Local Institution
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Local Institution
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
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
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Local Institution
City
Greenslopes
State/Province
Queensland
ZIP/Postal Code
4120
Country
Australia
Facility Name
Local Institution
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
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
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065 VIC
Country
Australia
Facility Name
Local Institution
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Local Institution
City
Parville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Local Institution
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Local Institution
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Local Institution
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution
City
Liege
ZIP/Postal Code
4000
Country
Belgium
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City
Santiago
State/Province
Metropolitana
Country
Chile
Facility Name
Local Institution
City
Hus
ZIP/Postal Code
00029
Country
Finland
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
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Local Institution
City
Nice Cedex 3
ZIP/Postal Code
06202
Country
France
Facility Name
Local Institution
City
Athens
ZIP/Postal Code
115 23
Country
Greece
Facility Name
Local Institution
City
Thessaloniki
ZIP/Postal Code
54006
Country
Greece
Facility Name
Local Institution
City
Hong Kong
Country
Hong Kong
Facility Name
Local Institution
City
Tai Po
Country
Hong Kong
Facility Name
Local Institution
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution
City
Novara
ZIP/Postal Code
28100
Country
Italy
Facility Name
Local Institution
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
8108563
Country
Japan
Facility Name
Local Institution
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
8030816
Country
Japan
Facility Name
Local Institution
City
Hiroshima-Shi
State/Province
Hiroshima
ZIP/Postal Code
7348551
Country
Japan
Facility Name
Local Institution
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0600033
Country
Japan
Facility Name
Local Institution
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
6500047
Country
Japan
Facility Name
Local Institution
City
Tsuchiura-shi
State/Province
Ibaraki
ZIP/Postal Code
300-0053
Country
Japan
Facility Name
Local Institution
City
Takamatsu-shi
State/Province
Kagawa
ZIP/Postal Code
7608557
Country
Japan
Facility Name
Local Institution
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
8908520
Country
Japan
Facility Name
Local Institution
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
2138587
Country
Japan
Facility Name
Local Institution
City
Okayama-shi
State/Province
Okayama
ZIP/Postal Code
7008558
Country
Japan
Facility Name
Local Institution
City
Iruma-gun
State/Province
Saitama
ZIP/Postal Code
3500495
Country
Japan
Facility Name
Local Institution
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
1138655
Country
Japan
Facility Name
Local Institution
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
1058470
Country
Japan
Facility Name
Local Institution
City
Musashino-shi
State/Province
Tokyo
ZIP/Postal Code
1808610
Country
Japan
Facility Name
Local Institution
City
Wakayama-shi
State/Province
Wakayama
ZIP/Postal Code
6408158
Country
Japan
Facility Name
Local Institution
City
Fukuoka
ZIP/Postal Code
8158555
Country
Japan
Facility Name
Local Institution
City
Miyazaki
ZIP/Postal Code
8800003
Country
Japan
Facility Name
Local Institution
City
Saga
ZIP/Postal Code
8408571
Country
Japan
Facility Name
Local Institution
City
Saitama
ZIP/Postal Code
3380001
Country
Japan
Facility Name
Local Institution
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Local Institution
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
Facility Name
Local Institution
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of
Facility Name
Local Institution
City
Daegu
ZIP/Postal Code
705-703
Country
Korea, Republic of
Facility Name
Local Institution
City
Gyeonggi-do
ZIP/Postal Code
425-707
Country
Korea, Republic of
Facility Name
Local Institution
City
Gyeonggi-do
ZIP/Postal Code
443-380
Country
Korea, Republic of
Facility Name
Local Institution
City
Gyeongsangnam-do
ZIP/Postal Code
626-770
Country
Korea, Republic of
Facility Name
Local Institution
City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
Local Institution
City
Incheon
ZIP/Postal Code
403-720
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
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Local Institution
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Local Institution
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
07760
Country
Mexico
Facility Name
Local Institution
City
Tlalpan
State/Province
Distrito Federal
ZIP/Postal Code
14000
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44500
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Local Institution
City
Distrito Federal
ZIP/Postal Code
03720
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
Country
Mexico
Facility Name
Local Institution
City
Mexico City
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Local Institution
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Local Institution
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Local Institution
City
Auckland
ZIP/Postal Code
92024
Country
New Zealand
Facility Name
Local Institution
City
Chelyabinsk
ZIP/Postal Code
454052
Country
Russian Federation
Facility Name
Local Institution
City
Irkutsk
ZIP/Postal Code
664003
Country
Russian Federation
Facility Name
Local Institution
City
Krasnoyarsk
ZIP/Postal Code
660049
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
107996
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
117593
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
121170
Country
Russian Federation
Facility Name
Local Institution
City
Saint-Petersburg
ZIP/Postal Code
190103
Country
Russian Federation
Facility Name
Local Institution
City
Saint-Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
Local Institution
City
Samara
ZIP/Postal Code
443063
Country
Russian Federation
Facility Name
Local Institution
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Facility Name
Local Institution
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Local Institution
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Local Institution
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Local Institution
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
Facility Name
Local Institution
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
Local Institution
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Local Institution
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Facility Name
Local Institution
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Local Institution
City
Yunlin
ZIP/Postal Code
64041
Country
Taiwan
Facility Name
Local Institution
City
Hull
State/Province
Humberside
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Local Institution
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Local Institution
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Local Institution
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom

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

Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3

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