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Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C

Primary Purpose

Hepatitis C Virus (HCV)

Status
Withdrawn
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pegylated Interferon Lambda
Pegylated 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 (HCV)

Eligibility Criteria

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

Inclusion Criteria:

  • Chronic hepatitis C, Genotype 1 or 4
  • HCV Ribonucleic acid (RNA) ≥ 100,000 IU/mL at screening
  • Liver biopsy documenting no cirrhosis (within prior 2 years) or cirrhosis (from any time prior to randomization). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease. Subjects with compensated cirrhosis can enroll and will be capped at 10%
  • Naive to prior anti-HCV therapy

Exclusion Criteria:

  • Infected with HCV other than Genotype 1 or 4
  • Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody or hepatitis D virus (HDV) at screening
  • Evidence of liver disease other than HCV
  • Active substance abuse
  • Use of hematologic growth factors within 90 days prior to study randomization
  • Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1: Pegylated Interferon Lambda + Ribavirin

Arm 2: Pegylated Interferon Alfa-2a + Ribavirin

Arm Description

Outcomes

Primary Outcome Measures

Efficacy of Lambda + Ribavirin (RBV) compared to Alfa + RBV in achieving a sustained virological response
The safety of Lambda + RBV compared to Alfa + RBV in reducing cytopenic abnormalities

Secondary Outcome Measures

Proportion of interferon-associated symptoms: a) Flu-like symptoms b) Musculoskeletal symptoms c) Neurologic symptoms d) Psychiatric symptoms e) Constitutional symptoms

Full Information

First Posted
October 4, 2011
Last Updated
February 2, 2012
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01447394
Brief Title
Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C
Official Title
A Double-Blinded Randomized Control Study Evaluating the Efficacy and Safety of Pegylated Lambda Interferon Compared to Pegylated Alfa-2a Interferon, Each in Combination With Ribavirin, in the Treatment of Naive Genotype 1 or 4 Chronic Hepatitis C Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Withdrawn
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

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 48 weeks of therapy with Pegylated Interferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy 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
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Pegylated Interferon Lambda + Ribavirin
Arm Type
Experimental
Arm Title
Arm 2: Pegylated Interferon Alfa-2a + Ribavirin
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Pegylated Interferon Lambda
Other Intervention Name(s)
BMS-914143
Intervention Description
Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks
Intervention Type
Biological
Intervention Name(s)
Pegylated Interferon Alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Ribasphere
Intervention Description
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks
Primary Outcome Measure Information:
Title
Efficacy of Lambda + Ribavirin (RBV) compared to Alfa + RBV in achieving a sustained virological response
Time Frame
At follow-up Week 24 (SVR24) following 48 weeks of treatment
Title
The safety of Lambda + RBV compared to Alfa + RBV in reducing cytopenic abnormalities
Time Frame
From Day 1 to end of Week 48 on-treatment
Secondary Outcome Measure Information:
Title
Proportion of interferon-associated symptoms: a) Flu-like symptoms b) Musculoskeletal symptoms c) Neurologic symptoms d) Psychiatric symptoms e) Constitutional symptoms
Time Frame
From Day 1 to end of Week 48 on-treatment

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: Chronic hepatitis C, Genotype 1 or 4 HCV Ribonucleic acid (RNA) ≥ 100,000 IU/mL at screening Liver biopsy documenting no cirrhosis (within prior 2 years) or cirrhosis (from any time prior to randomization). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease. Subjects with compensated cirrhosis can enroll and will be capped at 10% Naive to prior anti-HCV therapy Exclusion Criteria: Infected with HCV other than Genotype 1 or 4 Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody or hepatitis D virus (HDV) at screening Evidence of liver disease other than HCV Active substance abuse Use of hematologic growth factors within 90 days prior to study randomization Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
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
Local Institution
City
San Diego
State/Province
California
ZIP/Postal Code
92114
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United States
Facility Name
Local Institution
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Local Institution
City
Houston
State/Province
Texas
ZIP/Postal Code
77230
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United States
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H2
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Canada
Facility Name
Local Institution
City
Vaughan
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Ontario
ZIP/Postal Code
L4L 4Y7
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Canada
Facility Name
Local Institution
City
Hong Kong
State/Province
Hong Kong
ZIP/Postal Code
0
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China
Facility Name
Local Institution
City
Bogota
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Colombia
Facility Name
Local Institution
City
Cali
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Colombia
Facility Name
Local Institution
City
Medellin
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Colombia
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Local Institution
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Hradec Kralove
ZIP/Postal Code
500 05
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Czech Republic
Facility Name
Local Institution
City
Praha 4
ZIP/Postal Code
140 21
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Czech Republic
Facility Name
Local Institution
City
Usti Nad Labem
ZIP/Postal Code
400 01
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Czech Republic
Facility Name
Local Institution
City
Shebin Elkom
State/Province
Menoufiya
ZIP/Postal Code
35111
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Egypt
Facility Name
Local Institution
City
Cairo
ZIP/Postal Code
11559
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Egypt
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Local Institution
City
Lai Chi Kok
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Hong Kong
Facility Name
Local Institution
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Tai Po
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Hong Kong
Facility Name
Local Institution
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Budapest
ZIP/Postal Code
1097
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Hungary
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1126
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Hungary
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Local Institution
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Debrecen
ZIP/Postal Code
4043
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Hungary
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Local Institution
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Miskolc
ZIP/Postal Code
3529
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Hungary
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Local Institution
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Hyderabad
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Andhra Pradesh
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500082
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India
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Local Institution
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Coimbatore
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641005
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India
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Gurgaon
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122001
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India
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Ludhiana
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141001
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India
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Local Institution
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Nagpur
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440010
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India
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New Delhi
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110 070
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India
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Dublin 8
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Dublin
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Ireland
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Dublin
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DUBLIN 7
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Ireland
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Busan
ZIP/Postal Code
609-735
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Korea, Republic of
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Local Institution
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Busan
ZIP/Postal Code
614-735
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Korea, Republic of
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Local Institution
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Daegu
ZIP/Postal Code
700-721
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Korea, Republic of
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Local Institution
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Incheon
ZIP/Postal Code
400-711
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Korea, Republic of
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Local Institution
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Incheon
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403-720
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Korea, Republic of
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Local Institution
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Seoul
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110-744
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Korea, Republic of
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Local Institution
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Seoul
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120-752
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Korea, Republic of
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Local Institution
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Seoul
ZIP/Postal Code
135-710
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Korea, Republic of
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Local Institution
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Seoul
ZIP/Postal Code
138-736
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Korea, Republic of
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Local Institution
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Suwon
ZIP/Postal Code
443-721
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Korea, Republic of
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Local Institution
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Amsterdam
ZIP/Postal Code
1105 AZ
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Netherlands
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Local Institution
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Leiden
ZIP/Postal Code
2300
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Netherlands
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Local Institution
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Bialystok
ZIP/Postal Code
15-540
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Poland
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Bydgoszcz
ZIP/Postal Code
85-030
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Poland
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Chorzow
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41-500
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Poland
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Czeladz
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41-250
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Poland
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Kielce
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25-317
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Poland
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Krakow
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31-501
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Poland
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Lodz
ZIP/Postal Code
91-347
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Poland
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Lublin
ZIP/Postal Code
20-081
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Poland
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Olsztyn
ZIP/Postal Code
10-082
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Poland
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Pulawy
ZIP/Postal Code
24-100
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Poland
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Raciborz
ZIP/Postal Code
47-400
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Poland
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Sosnowiec
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41-200
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Poland
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Warszawa
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01-201
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Poland
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Wroclaw
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50-220
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Poland
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Zielona Gora
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65-046
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Poland
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Bucharest
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021105
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Romania
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Iasi
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700506
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Romania
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Timisoara
ZIP/Postal Code
300002
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Romania
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Ioshkar-Ola
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Mari El
ZIP/Postal Code
424006
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Russian Federation
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Kaluga
ZIP/Postal Code
248023
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Russian Federation
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Lipetsk
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398043
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Russian Federation
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Moscow
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111123
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Russian Federation
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Moscow
ZIP/Postal Code
115446
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Russian Federation
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Moscow
ZIP/Postal Code
117333
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Russian Federation
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Nizhniy Novgorod
ZIP/Postal Code
603022
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Russian Federation
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Local Institution
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Poselok Noviy
ZIP/Postal Code
143420
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Russian Federation
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Local Institution
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Samara
ZIP/Postal Code
443077
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Russian Federation
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Saratov
ZIP/Postal Code
410009
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Russian Federation
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Smolensk
ZIP/Postal Code
214006
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Russian Federation
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Smolensk
ZIP/Postal Code
214018
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Russian Federation
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St. Petersburg
ZIP/Postal Code
191167
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Russian Federation
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St. Petersburg
ZIP/Postal Code
194044
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Russian Federation
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St. Petersburg
ZIP/Postal Code
196645
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Russian Federation
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St.Petersburg
ZIP/Postal Code
193137
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Russian Federation
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St.Petersburg
ZIP/Postal Code
198103
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Russian Federation
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Toliatti
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445846
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Russian Federation
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Local Institution
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Volgograd
ZIP/Postal Code
400040
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Russian Federation
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Local Institution
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Singapore
ZIP/Postal Code
119228
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Singapore
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Local Institution
City
Singapore
ZIP/Postal Code
169608
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Singapore
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Local Institution
City
Singapore
ZIP/Postal Code
308433
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Singapore
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Local Institution
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Singapore
ZIP/Postal Code
529889
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Singapore
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Local Institution
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A Coruna
ZIP/Postal Code
15006
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Spain
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Local Institution
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Barcelona
ZIP/Postal Code
08003
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Spain
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Local Institution
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Barcelona
ZIP/Postal Code
08035
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Spain
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Local Institution
City
Barcelona
ZIP/Postal Code
08036
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Spain
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City
Madrid
ZIP/Postal Code
28046
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Spain
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Local Institution
City
Kaohsiung
ZIP/Postal Code
80756
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Taiwan
Facility Name
Local Institution
City
Kaohsiung
ZIP/Postal Code
833
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Taiwan
Facility Name
Local Institution
City
Taichung
ZIP/Postal Code
404
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Taiwan
Facility Name
Local Institution
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
112
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Taiwan
Facility Name
Local Institution
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Local Institution
City
Bornova Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Local Institution
City
Diyarbakir
ZIP/Postal Code
21280
Country
Turkey
Facility Name
Local Institution
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Local Institution
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
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Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
W2 1NY
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United Kingdom
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Local Institution
City
Edinburgh
State/Province
Midlothian
ZIP/Postal Code
EH4 2XU
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United Kingdom
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Local Institution
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B15 2TH
Country
United Kingdom

12. IPD Sharing Statement

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Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C

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