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Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir (PEDESTAL)

Primary Purpose

Hepatitis C Virus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Peginterferon Lambda-1a
Peginterferon Alfa-2a
Ribavirin
Telaprevir
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

undefined - undefined (Child, 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 1. GT-1b Capped at 50 % of naïve subjects
  • Naives to prior anti-HCV therapy [Interferon (IFN) and direct antiviral agent (DAA) based]
  • Relapsers (defined as subjects who had undetectable HCV ribonucleic acid (RNA) on prior treatment regimen of alfa-2a/RBV and Hepatitis C Virus (HCV) RNA > 25IU/mL after discontinuation of treatment). Capped at 20%
  • HCV RNA ≥ 100,000 IU/mL
  • Subjects with compensated cirrhosis can be enrolled and will be capped at approximately 10%
  • Seronegative for human immunodeficiency virus (HIV) and hepatitis B surface antigen (HBsAg)
  • Men or women, 18-70 years of age

Exclusion Criteria:

  • Chronic liver disease due to causes other than chronic HCV
  • Current or past evidence of decompensation
  • Conditions that preclude the use of Alfa/RBV/TVR per respective labels
  • Diagnosed or suspected hepatocellular carcinoma

Sites / Locations

  • Birmingham Gastroenterology Associates, P.C.
  • The Kirklin Clinic
  • The University Of Alabama Of Birmingham
  • Anaheim Clinical Trials Llc
  • Sc Clinical Research, Inc.
  • Va Long Beach Healthcare System
  • Cedars Sinai Medical Center
  • Va Greater Los Angeles Healthcare System
  • University Of California, San Francisco/Sf General Hospital
  • South Bay Ge Medical Group
  • Orlando Va Medical Center
  • Orlando Clinical Research Center
  • Infectious Disease Research Institute, Inc.
  • Gastrointestinal Specialists Of Georgia Pc
  • Mercy Medical Center
  • Saint Luke'S Transplant Specialists
  • Saint Louis University
  • Carolinas Medical Center
  • Options Health Research, Llc
  • Healthcare Research Consultants
  • Gastro One
  • Texas Clinical Research Institute
  • Brooke Army Medical Center
  • Alamo Medical Research
  • Clinical Research Centers Of America
  • Metropolitan Research
  • Bon Secours St. Mary'S Hospital Of Richmond, Inc.
  • Digestive And Liver Disease Specialists
  • 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
  • University Of Calgary
  • Liver And Intestinal Research Centre (Lair)
  • Gastrointestinal Research Institute (G.I.R.I.)
  • Percuro Clinical Research Ltd
  • Toronto General Hospital
  • Hopital Maisonneuve-Rosemont
  • 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
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part A: Peginterferon Lambda-1a + RBV + TVR

Part B (Arm 1): Peginterferon Lambda-1a + RBV + TVR

Part B (Arm 2): Peginterferon Lambda-2a + RBV + TVR

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A
eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal product. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or caused prolongation of existing hospitalization.

Secondary Outcome Measures

Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A
SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ =25 IU/mL; limit of detection ~ 10 IU/mL).
Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A
SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection ~ 10 IU/mL). The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.
Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).
Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B
Cytopenic abnormalities included anemia defined as hemoglobin <10 grams/decilitre; neutropenia defined as Absolute neutrophil count (ANC) <750 cubic millimetre (mm^3); thrombocytopenia defined as platelets <50,000 mm^3.
Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B
eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).
Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B
Flu-like symptoms included pyrexia, chills, and pain. Musculoskeletal symptoms included arthralgia, myalgia, and back pain.
Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B
SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection ~ 10 IU/mL).
Percentage of Participants With Rash
All skin reactions involving rash or rash-like events that occurred on treatment were reported.

Full Information

First Posted
May 9, 2012
Last Updated
July 29, 2019
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01598090
Brief Title
Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir
Acronym
PEDESTAL
Official Title
A Phase 3 Blinded Randomized Study of Peginterferon Lambda-1a and Ribavirin Compared to Peginterferon Alfa-2a and Ribavirin, Each Administered With Telaprevir in Subjects With Genotype-1 Chronic Hepatitis C Who Are Treatment-naive or Relapsed on Prior Treatment With Peginterferon Alfa-2a and Ribavirin
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 14, 2012 (Actual)
Primary Completion Date
February 4, 2015 (Actual)
Study Completion Date
May 15, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.

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 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
881 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: Peginterferon Lambda-1a + RBV + TVR
Arm Type
Experimental
Arm Title
Part B (Arm 1): Peginterferon Lambda-1a + RBV + TVR
Arm Type
Experimental
Arm Title
Part B (Arm 2): Peginterferon Lambda-2a + RBV + TVR
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Peginterferon Lambda-1a
Intervention Description
Syringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response
Intervention Type
Biological
Intervention Name(s)
Peginterferon Alfa-2a
Other Intervention Name(s)
Pegasys
Intervention Description
Syringes, SC, 180μg, Once weekly, 24 or 48 weeks depending on response
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response
Intervention Type
Drug
Intervention Name(s)
Telaprevir
Other Intervention Name(s)
Incivek
Intervention Description
Tablets, Oral, 750 mg, three times a day, 12 weeks only
Primary Outcome Measure Information:
Title
Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A
Description
eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).
Time Frame
Assessed at Week 4 and Week 12, week 12 reported
Title
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
Description
SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).
Time Frame
Follow-up Week 12
Title
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A
Description
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal product. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or caused prolongation of existing hospitalization.
Time Frame
Day 1 of treatment up to Week 48
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A
Description
SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ =25 IU/mL; limit of detection ~ 10 IU/mL).
Time Frame
Follow-up Week 12
Title
Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A
Description
SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection ~ 10 IU/mL). The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants.
Time Frame
Follow up week 24
Title
Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B
Description
SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).
Time Frame
Follow-up Week 12
Title
Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B
Description
Cytopenic abnormalities included anemia defined as hemoglobin <10 grams/decilitre; neutropenia defined as Absolute neutrophil count (ANC) <750 cubic millimetre (mm^3); thrombocytopenia defined as platelets <50,000 mm^3.
Time Frame
After Day 1 of treatment up to Week 48
Title
Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B
Description
eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection ~ 10 IU/mL).
Time Frame
Week 4 and Week 12
Title
Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B
Description
Flu-like symptoms included pyrexia, chills, and pain. Musculoskeletal symptoms included arthralgia, myalgia, and back pain.
Time Frame
After Day 1 of treatment up to Week 48
Title
Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B
Description
SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection ~ 10 IU/mL).
Time Frame
Follow-up Week 24
Title
Percentage of Participants With Rash
Description
All skin reactions involving rash or rash-like events that occurred on treatment were reported.
Time Frame
After Day 1 of treatment up to Week 48

10. Eligibility

Sex
All
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 1. GT-1b Capped at 50 % of naïve subjects Naives to prior anti-HCV therapy [Interferon (IFN) and direct antiviral agent (DAA) based] Relapsers (defined as subjects who had undetectable HCV ribonucleic acid (RNA) on prior treatment regimen of alfa-2a/RBV and Hepatitis C Virus (HCV) RNA > 25IU/mL after discontinuation of treatment). Capped at 20% HCV RNA ≥ 100,000 IU/mL Subjects with compensated cirrhosis can be enrolled and will be capped at approximately 10% Seronegative for human immunodeficiency virus (HIV) and hepatitis B surface antigen (HBsAg) Men or women, 18-70 years of age Exclusion Criteria: Chronic liver disease due to causes other than chronic HCV Current or past evidence of decompensation Conditions that preclude the use of Alfa/RBV/TVR per respective labels Diagnosed or suspected hepatocellular carcinoma
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
Birmingham Gastroenterology Associates, P.C.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
The Kirklin Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
The University Of Alabama Of Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Anaheim Clinical Trials Llc
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Sc Clinical Research, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92844
Country
United States
Facility Name
Va Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Va Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
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
South Bay Ge Medical Group
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Orlando Va Medical Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Infectious Disease Research Institute, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Gastrointestinal Specialists Of Georgia Pc
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Saint Luke'S Transplant Specialists
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
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
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Texas Clinical Research Institute
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Clinical Research Centers Of America
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Metropolitan Research
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Bon Secours St. Mary'S Hospital Of Richmond, Inc.
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Facility Name
Digestive And Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Local Institution
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Local Institution
City
Linz
ZIP/Postal Code
4010
Country
Austria
Facility Name
Local Institution
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution
City
Edegem
ZIP/Postal Code
2650
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
Facility Name
Local Institution
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40110-160
Country
Brazil
Facility Name
Local Institution
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40110
Country
Brazil
Facility Name
Local Institution
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80240-280
Country
Brazil
Facility Name
Local Institution
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80240
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
RIO Grande DO SUL
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035
Country
Brazil
Facility Name
Local Institution
City
Botucatu
State/Province
SAO Paulo
ZIP/Postal Code
18618-000
Country
Brazil
Facility Name
Local Institution
City
Botucatu
State/Province
Sao Paulo
ZIP/Postal Code
18618
Country
Brazil
Facility Name
Local Institution
City
Rio De Janeiro
ZIP/Postal Code
21040-000
Country
Brazil
Facility Name
Local Institution
City
Rio De Janeiro
ZIP/Postal Code
21040
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
04035-970
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
04035
Country
Brazil
Facility Name
University Of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Liver And Intestinal Research Centre (Lair)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H2
Country
Canada
Facility Name
Gastrointestinal Research Institute (G.I.R.I.)
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
Percuro Clinical Research Ltd
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3P9
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2N2
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Local Institution
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Local Institution
City
Praha 2
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Local Institution
City
Praha 4
ZIP/Postal Code
140 21
Country
Czechia
Facility Name
Local Institution
City
Orleans Cedex 2
ZIP/Postal Code
45067
Country
France
Facility Name
Local Institution
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Local Institution
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Local Institution
City
Rouen Cedex
ZIP/Postal Code
76031
Country
France
Facility Name
Local Institution
City
Toulouse Cedex
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution
City
Villejuif
ZIP/Postal Code
94804
Country
France
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
10969
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
20246
Country
Germany
Facility Name
Local Institution
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Local Institution
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Local Institution
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Local Institution
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Local Institution
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Facility Name
Local Institution
City
Nazareth
ZIP/Postal Code
16100
Country
Israel
Facility Name
Local Institution
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Local Institution
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Facility Name
Local Institution
City
Cisanello (pisa)
ZIP/Postal Code
56124
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20121
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00149
Country
Italy
Facility Name
Local Institution
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Local Institution
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
Facility Name
Local Institution
City
Kielce
ZIP/Postal Code
25-726
Country
Poland
Facility Name
Local Institution
City
Lancut
ZIP/Postal Code
37-100
Country
Poland
Facility Name
Local Institution
City
Myslowice
ZIP/Postal Code
41-400
Country
Poland
Facility Name
Local Institution
City
Raciborz
ZIP/Postal Code
47-400
Country
Poland
Facility Name
Local Institution
City
Wroclaw
ZIP/Postal Code
50-220
Country
Poland
Facility Name
Local Institution
City
Kazan
State/Province
Republic OF Tatarstan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
105275
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
111123
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
115446
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
117198
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
127015
Country
Russian Federation
Facility Name
Local Institution
City
Saint Petersburg
ZIP/Postal Code
194100
Country
Russian Federation
Facility Name
Local Institution
City
St-petersburg
ZIP/Postal Code
198103
Country
Russian Federation
Facility Name
Local Institution
City
Stavropol
ZIP/Postal Code
355017
Country
Russian Federation
Facility Name
Local Institution
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Local Institution
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Local Institution
City
San Sebastian
ZIP/Postal Code
20014
Country
Spain
Facility Name
Local Institution
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Local Institution
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Local Institution
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Local Institution
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Local Institution
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Local Institution
City
Birmingham
State/Province
WEST Midlands
ZIP/Postal Code
B15 2TH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23743475
Citation
Heim MH. 25 years of interferon-based treatment of chronic hepatitis C: an epoch coming to an end. Nat Rev Immunol. 2013 Jul;13(7):535-42. doi: 10.1038/nri3463. Epub 2013 Jun 7.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir

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