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Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BI 207127-placebo: 8-week treatment
Ribavirin: 24-week treatment
BI 207127: 24-week treatment
Faldaprevir: 24-week treatment
Faldaprevir: 24-week treatment
Ribavirin-placebo: 8-week treatment
BI 207127: 24-week treatment
Faldaprevir-placebo: 8-week treatment
Faldaprevir: 16-week treatment
Ribavirin: 16-week treatment
RBV: 24-week treatment
BI 207127: 16-week treatment
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening
  2. HCV infection of sub-GT1b confirmed by genotypic testing at screening.
  3. HCV viral load =1,000 IU/mL at randomisation.
  4. Patients who have never been previously treated with any other HCV treatment regimen.

Exclusion criteria:

  1. HCV infection of mixed GT (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening.
  2. HCV infection of sub-GT1a, mixed GT1a/1b, or undefined GT1.
  3. Liver disease due to causes other than chronic HCV infection.
  4. HIV infection.
  5. Hepatitis B virus infection based on presence of HBs-Ag.
  6. Confirmed or suspected active malignancy or history of malignancy within the last 5 years prior to screening.
  7. History of illicit drug abuse other than cannabis or chronic alcohol abuse within 12 months prior to randomisation.
  8. Subject is not willing to comply with the precautionary measures to prevent photosensitivity (avoid excessive sun exposure and use sun block on a daily basis).
  9. Decompensated liver disease, or history of decompensated liver disease.
  10. Clinical evidence of unstable cardiovascular disease which may further decompensate due to anemia.
  11. Red blood cell disorders.
  12. Body weight <40 kg or >125 kg.

Sites / Locations

  • 1241.36.00016 Boehringer Ingelheim Investigational Site
  • 1241.36.00020 Boehringer Ingelheim Investigational Site
  • 1241.36.00005 Boehringer Ingelheim Investigational Site
  • 1241.36.00009 Boehringer Ingelheim Investigational Site
  • 1241.36.00007 Boehringer Ingelheim Investigational Site
  • 1241.36.00013 Boehringer Ingelheim Investigational Site
  • 1241.36.00019 Boehringer Ingelheim Investigational Site
  • 1241.36.00034 Boehringer Ingelheim Investigational Site
  • 1241.36.00022 Boehringer Ingelheim Investigational Site
  • 1241.36.00004 Boehringer Ingelheim Investigational Site
  • 1241.36.00006 Boehringer Ingelheim Investigational Site
  • 1241.36.00003 Boehringer Ingelheim Investigational Site
  • 1241.36.00010 Boehringer Ingelheim Investigational Site
  • 1241.36.00024 Boehringer Ingelheim Investigational Site
  • 1241.36.00030 Boehringer Ingelheim Investigational Site
  • 1241.36.00027 Boehringer Ingelheim Investigational Site
  • 1241.36.00033 Boehringer Ingelheim Investigational Site
  • 1241.36.00035 Boehringer Ingelheim Investigational Site
  • 1241.36.00001 Boehringer Ingelheim Investigational Site
  • 1241.36.00017 Boehringer Ingelheim Investigational Site
  • 1241.36.00018 Boehringer Ingelheim Investigational Site
  • 1241.36.00043 Boehringer Ingelheim Investigational Site
  • 1241.36.00032 Boehringer Ingelheim Investigational Site
  • 1241.36.00002 Boehringer Ingelheim Investigational Site
  • 1241.36.00039 Boehringer Ingelheim Investigational Site
  • 1241.36.00031 Boehringer Ingelheim Investigational Site
  • 1241.36.00008 Boehringer Ingelheim Investigational Site
  • 1241.36.00026 Boehringer Ingelheim Investigational Site
  • 1241.36.00044 Boehringer Ingelheim Investigational Site
  • 1241.36.00015 Boehringer Ingelheim Investigational Site
  • 1241.36.00029 Boehringer Ingelheim Investigational Site
  • 1241.36.61005 Boehringer Ingelheim Investigational Site
  • 1241.36.61010 Boehringer Ingelheim Investigational Site
  • 1241.36.61009 Boehringer Ingelheim Investigational Site
  • 1241.36.61007 Boehringer Ingelheim Investigational Site
  • 1241.36.61002 Boehringer Ingelheim Investigational Site
  • 1241.36.61004 Boehringer Ingelheim Investigational Site
  • 1241.36.61001 Boehringer Ingelheim Investigational Site
  • 1241.36.61008 Boehringer Ingelheim Investigational Site
  • 1241.36.61006 Boehringer Ingelheim Investigational Site
  • 1241.36.32006 Boehringer Ingelheim Investigational Site
  • 1241.36.32001 Boehringer Ingelheim Investigational Site
  • 1241.36.32004 Boehringer Ingelheim Investigational Site
  • 1241.36.32005 Boehringer Ingelheim Investigational Site
  • 1241.36.32002 Boehringer Ingelheim Investigational Site
  • 1241.36.32003 Boehringer Ingelheim Investigational Site
  • 1241.36.32007 Boehringer Ingelheim Investigational Site
  • 1241.36.01005 Boehringer Ingelheim Investigational Site
  • 1241.36.01006 Boehringer Ingelheim Investigational Site
  • 1241.36.01002 Boehringer Ingelheim Investigational Site
  • 1241.36.01003 Boehringer Ingelheim Investigational Site
  • 1241.36.01001 Boehringer Ingelheim Investigational Site
  • 1241.36.01004 Boehringer Ingelheim Investigational Site
  • 1241.36.01007 Boehringer Ingelheim Investigational Site
  • 1241.36.33001 Boehringer Ingelheim Investigational Site
  • 1241.36.33004 Boehringer Ingelheim Investigational Site
  • 1241.36.33002 Boehringer Ingelheim Investigational Site
  • 1241.36.33003 Boehringer Ingelheim Investigational Site
  • 1241.36.33008 Boehringer Ingelheim Investigational Site
  • 1241.36.33006 Boehringer Ingelheim Investigational Site
  • 1241.36.33005 Boehringer Ingelheim Investigational Site
  • 1241.36.33007 Boehringer Ingelheim Investigational Site
  • 1241.36.49011 Boehringer Ingelheim Investigational Site
  • 1241.36.49001 Boehringer Ingelheim Investigational Site
  • 1241.36.49012 Boehringer Ingelheim Investigational Site
  • 1241.36.49004 Boehringer Ingelheim Investigational Site
  • 1241.36.49008 Boehringer Ingelheim Investigational Site
  • 1241.36.49009 Boehringer Ingelheim Investigational Site
  • 1241.36.49014 Boehringer Ingelheim Investigational Site
  • 1241.36.49002 Boehringer Ingelheim Investigational Site
  • 1241.36.49007 Boehringer Ingelheim Investigational Site
  • 1241.36.49013 Boehringer Ingelheim Investigational Site
  • 1241.36.30001 Boehringer Ingelheim Investigational Site
  • 1241.36.30002 Boehringer Ingelheim Investigational Site
  • 1241.36.30003 Boehringer Ingelheim Investigational Site
  • 1241.36.30004 Boehringer Ingelheim Investigational Site
  • 1241.36.39025 Boehringer Ingelheim Investigational Site
  • 1241.36.39023 Boehringer Ingelheim Investigational Site
  • 1241.36.39021 Boehringer Ingelheim Investigational Site
  • 1241.36.39022 Boehringer Ingelheim Investigational Site
  • 1241.36.39020 Boehringer Ingelheim Investigational Site
  • 1241.36.39026 Boehringer Ingelheim Investigational Site
  • 1241.36.39028 Boehringer Ingelheim Investigational Site
  • 1241.36.39029 Boehringer Ingelheim Investigational Site
  • 1241.36.39024 Boehringer Ingelheim Investigational Site
  • 1241.36.64001 Boehringer Ingelheim Investigational Site
  • 1241.36.64002 Boehringer Ingelheim Investigational Site
  • 1241.36.35103 Boehringer Ingelheim Investigational Site
  • 1241.36.35104 Boehringer Ingelheim Investigational Site
  • 1241.36.35101 Boehringer Ingelheim Investigational Site
  • 1241.36.34006 Boehringer Ingelheim Investigational Site
  • 1241.36.34002 Boehringer Ingelheim Investigational Site
  • 1241.36.34004 Boehringer Ingelheim Investigational Site
  • 1241.36.34001 Boehringer Ingelheim Investigational Site
  • 1241.36.34005 Boehringer Ingelheim Investigational Site
  • 1241.36.34008 Boehringer Ingelheim Investigational Site
  • 1241.36.34003 Boehringer Ingelheim Investigational Site
  • 1241.36.34007 Boehringer Ingelheim Investigational Site
  • 1241.36.44003 Boehringer Ingelheim Investigational Site
  • 1241.36.44006 Boehringer Ingelheim Investigational Site
  • 1241.36.44011 Boehringer Ingelheim Investigational Site
  • 1241.36.44013 Boehringer Ingelheim Investigational Site
  • 1241.36.44008 Boehringer Ingelheim Investigational Site
  • 1241.36.44001 Boehringer Ingelheim Investigational Site
  • 1241.36.44005 Boehringer Ingelheim Investigational Site
  • 1241.36.44007 Boehringer Ingelheim Investigational Site
  • 1241.36.44010 Boehringer Ingelheim Investigational Site
  • 1241.36.44002 Boehringer Ingelheim Investigational Site
  • 1241.36.44004 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Randomised 24-week arm

Randomised 16-week arm

Allocated 24-week arm

Arm Description

BI 207127 in combination with FDV and RBV for 24 weeks (randomised)

BI 207127-placebo, FDV-placebo and RBV-placebo for 8 weeks followed by BI 207127 in combination with FDV and RBV for 16 weeks (randomised)

BI 207127 in combination with FDV and RBV for 24 weeks (allocated to patients with compensated cirrhosis)

Outcomes

Primary Outcome Measures

SVR12 Rates With Historical Control
Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level <25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint. The number of participants analyzed are actually adjusted number of participant analyzed.
Comparisons of SVR12 Rates Across Treatment Arms
Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.

Secondary Outcome Measures

SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT.
Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level <25 IU/mL at 4 weeks after EOT.
SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT.
Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level <25 IU/mL at 24 weeks after EOT.
Prognostic Value of SVR12 Predicting SVR24
The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed.

Full Information

First Posted
November 2, 2012
Last Updated
January 14, 2016
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT01728324
Brief Title
Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2
Official Title
A Phase III Randomised, Partially Double-blind and Placebo-controlled Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Chronic Genotype 1 Hepatitis C Infection in an Extended Population of Treatment naïve Patients That Includes Those Ineligible to Receive Peginterferon
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
496 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Randomised 24-week arm
Arm Type
Experimental
Arm Description
BI 207127 in combination with FDV and RBV for 24 weeks (randomised)
Arm Title
Randomised 16-week arm
Arm Type
Experimental
Arm Description
BI 207127-placebo, FDV-placebo and RBV-placebo for 8 weeks followed by BI 207127 in combination with FDV and RBV for 16 weeks (randomised)
Arm Title
Allocated 24-week arm
Arm Type
Experimental
Arm Description
BI 207127 in combination with FDV and RBV for 24 weeks (allocated to patients with compensated cirrhosis)
Intervention Type
Drug
Intervention Name(s)
BI 207127-placebo: 8-week treatment
Intervention Description
8 weeks of placebo treatment
Intervention Type
Drug
Intervention Name(s)
Ribavirin: 24-week treatment
Intervention Description
24 weeks of active treatment
Intervention Type
Drug
Intervention Name(s)
BI 207127: 24-week treatment
Intervention Description
24 weeks of active treatment
Intervention Type
Drug
Intervention Name(s)
Faldaprevir: 24-week treatment
Intervention Description
24 weeks of active treatment
Intervention Type
Drug
Intervention Name(s)
Faldaprevir: 24-week treatment
Intervention Description
24 weeks of active treatment
Intervention Type
Drug
Intervention Name(s)
Ribavirin-placebo: 8-week treatment
Intervention Description
8 weeks of placebo treatment
Intervention Type
Drug
Intervention Name(s)
BI 207127: 24-week treatment
Intervention Description
24 weeks of active treatment
Intervention Type
Drug
Intervention Name(s)
Faldaprevir-placebo: 8-week treatment
Intervention Description
8 weeks of placebo treatment
Intervention Type
Drug
Intervention Name(s)
Faldaprevir: 16-week treatment
Intervention Description
16 weeks of active treatment
Intervention Type
Drug
Intervention Name(s)
Ribavirin: 16-week treatment
Intervention Description
16 weeks of active treatment
Intervention Type
Drug
Intervention Name(s)
RBV: 24-week treatment
Intervention Description
24 weeks of active treatment
Intervention Type
Drug
Intervention Name(s)
BI 207127: 16-week treatment
Intervention Description
16 weeks of active treatment
Primary Outcome Measure Information:
Title
SVR12 Rates With Historical Control
Description
Sustained Virologic Response at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus (HCV) RNA level <25 IU/mL at 12 weeks after end of Treatment (EOT). SVR12, was assessed based on the observed HCV RNA result taken at least 10 weeks after treatment discontinuation. This definition was also applied to patients who discontinued treatment early: if the patient had HCV RNA undetected at least 10 weeks after stopping all treatment, they were considered a responder in the primary analysis. This is the primary analyses of the primary endpoint. The number of participants analyzed are actually adjusted number of participant analyzed.
Time Frame
12 Week (post-treatment)
Title
Comparisons of SVR12 Rates Across Treatment Arms
Description
Sustained Virologic Response rates across treatment arms at Week 12 post-treatment (SVR12). This is the secondary analyses of the primary endpoint.
Time Frame
12 Week (post-treatment)
Secondary Outcome Measure Information:
Title
SVR4: Plasma HCV RNA Level <25 IU/mL at 4 Weeks After EOT.
Description
Sustained Virologic Response rates across treatment arms at Week 4 post-treatment (SVR4): Plasma HCV RNA level <25 IU/mL at 4 weeks after EOT.
Time Frame
4 weeks (after End Of Treatment)
Title
SVR24: Plasma HCV RNA Level <25 IU/mL at 24 Weeks After EOT.
Description
Sustained Virologic Response rates across treatment arms at Week 24 post-treatment (SVR24): Plasma HCV RNA level <25 IU/mL at 24 weeks after EOT.
Time Frame
4 weeks (after End Of Treatment)
Title
Prognostic Value of SVR12 Predicting SVR24
Description
The positive predictive value of SVR12 predicting SVR24 are the patients with an SVR12 (=YES) and the SVR24 was assessed.
Time Frame
24 Week (post-treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening HCV infection of sub-GT1b confirmed by genotypic testing at screening. HCV viral load =1,000 IU/mL at randomisation. Patients who have never been previously treated with any other HCV treatment regimen. Exclusion criteria: HCV infection of mixed GT (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening. HCV infection of sub-GT1a, mixed GT1a/1b, or undefined GT1. Liver disease due to causes other than chronic HCV infection. HIV infection. Hepatitis B virus infection based on presence of HBs-Ag. Confirmed or suspected active malignancy or history of malignancy within the last 5 years prior to screening. History of illicit drug abuse other than cannabis or chronic alcohol abuse within 12 months prior to randomisation. Subject is not willing to comply with the precautionary measures to prevent photosensitivity (avoid excessive sun exposure and use sun block on a daily basis). Decompensated liver disease, or history of decompensated liver disease. Clinical evidence of unstable cardiovascular disease which may further decompensate due to anemia. Red blood cell disorders. Body weight <40 kg or >125 kg.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1241.36.00016 Boehringer Ingelheim Investigational Site
City
North Little Rock
State/Province
Arkansas
Country
United States
Facility Name
1241.36.00020 Boehringer Ingelheim Investigational Site
City
Anaheim
State/Province
California
Country
United States
Facility Name
1241.36.00005 Boehringer Ingelheim Investigational Site
City
Bakersfield
State/Province
California
Country
United States
Facility Name
1241.36.00009 Boehringer Ingelheim Investigational Site
City
La Jolla
State/Province
California
Country
United States
Facility Name
1241.36.00007 Boehringer Ingelheim Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1241.36.00013 Boehringer Ingelheim Investigational Site
City
Oceanside
State/Province
California
Country
United States
Facility Name
1241.36.00019 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
1241.36.00034 Boehringer Ingelheim Investigational Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
1241.36.00022 Boehringer Ingelheim Investigational Site
City
Bradenton
State/Province
Florida
Country
United States
Facility Name
1241.36.00004 Boehringer Ingelheim Investigational Site
City
Deland
State/Province
Florida
Country
United States
Facility Name
1241.36.00006 Boehringer Ingelheim Investigational Site
City
Fort Lauderdale
State/Province
Florida
Country
United States
Facility Name
1241.36.00003 Boehringer Ingelheim Investigational Site
City
Gainesville
State/Province
Florida
Country
United States
Facility Name
1241.36.00010 Boehringer Ingelheim Investigational Site
City
Orlando
State/Province
Florida
Country
United States
Facility Name
1241.36.00024 Boehringer Ingelheim Investigational Site
City
Palm Harbor
State/Province
Florida
Country
United States
Facility Name
1241.36.00030 Boehringer Ingelheim Investigational Site
City
Zephyrhills
State/Province
Florida
Country
United States
Facility Name
1241.36.00027 Boehringer Ingelheim Investigational Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
1241.36.00033 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
1241.36.00035 Boehringer Ingelheim Investigational Site
City
Springfield
State/Province
Illinois
Country
United States
Facility Name
1241.36.00001 Boehringer Ingelheim Investigational Site
City
Valparaiso
State/Province
Indiana
Country
United States
Facility Name
1241.36.00017 Boehringer Ingelheim Investigational Site
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
1241.36.00018 Boehringer Ingelheim Investigational Site
City
Tupelo
State/Province
Mississippi
Country
United States
Facility Name
1241.36.00043 Boehringer Ingelheim Investigational Site
City
Kansas City
State/Province
Missouri
Country
United States
Facility Name
1241.36.00032 Boehringer Ingelheim Investigational Site
City
Hillsborough
State/Province
New Jersey
Country
United States
Facility Name
1241.36.00002 Boehringer Ingelheim Investigational Site
City
Arlington
State/Province
Texas
Country
United States
Facility Name
1241.36.00039 Boehringer Ingelheim Investigational Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
1241.36.00031 Boehringer Ingelheim Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
1241.36.00008 Boehringer Ingelheim Investigational Site
City
Murray
State/Province
Utah
Country
United States
Facility Name
1241.36.00026 Boehringer Ingelheim Investigational Site
City
Charlottesville
State/Province
Virginia
Country
United States
Facility Name
1241.36.00044 Boehringer Ingelheim Investigational Site
City
Newport News
State/Province
Virginia
Country
United States
Facility Name
1241.36.00015 Boehringer Ingelheim Investigational Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
1241.36.00029 Boehringer Ingelheim Investigational Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
1241.36.61005 Boehringer Ingelheim Investigational Site
City
Camperdown
State/Province
New South Wales
Country
Australia
Facility Name
1241.36.61010 Boehringer Ingelheim Investigational Site
City
Kogarah
State/Province
New South Wales
Country
Australia
Facility Name
1241.36.61009 Boehringer Ingelheim Investigational Site
City
New Lambton
State/Province
New South Wales
Country
Australia
Facility Name
1241.36.61007 Boehringer Ingelheim Investigational Site
City
Randwick
State/Province
New South Wales
Country
Australia
Facility Name
1241.36.61002 Boehringer Ingelheim Investigational Site
City
Herston
State/Province
Queensland
Country
Australia
Facility Name
1241.36.61004 Boehringer Ingelheim Investigational Site
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
1241.36.61001 Boehringer Ingelheim Investigational Site
City
Darlinghurst
State/Province
Victoria
Country
Australia
Facility Name
1241.36.61008 Boehringer Ingelheim Investigational Site
City
Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
1241.36.61006 Boehringer Ingelheim Investigational Site
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
1241.36.32006 Boehringer Ingelheim Investigational Site
City
Antwerpen
Country
Belgium
Facility Name
1241.36.32001 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
1241.36.32004 Boehringer Ingelheim Investigational Site
City
Edegem
Country
Belgium
Facility Name
1241.36.32005 Boehringer Ingelheim Investigational Site
City
Gent
Country
Belgium
Facility Name
1241.36.32002 Boehringer Ingelheim Investigational Site
City
Leuven
Country
Belgium
Facility Name
1241.36.32003 Boehringer Ingelheim Investigational Site
City
Liège
Country
Belgium
Facility Name
1241.36.32007 Boehringer Ingelheim Investigational Site
City
Roeselare
Country
Belgium
Facility Name
1241.36.01005 Boehringer Ingelheim Investigational Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
1241.36.01006 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1241.36.01002 Boehringer Ingelheim Investigational Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
1241.36.01003 Boehringer Ingelheim Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
1241.36.01001 Boehringer Ingelheim Investigational Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
1241.36.01004 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1241.36.01007 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1241.36.33001 Boehringer Ingelheim Investigational Site
City
Clichy Cedex
Country
France
Facility Name
1241.36.33004 Boehringer Ingelheim Investigational Site
City
Creteil
Country
France
Facility Name
1241.36.33002 Boehringer Ingelheim Investigational Site
City
Grenoble Cedex 9
Country
France
Facility Name
1241.36.33003 Boehringer Ingelheim Investigational Site
City
Paris Cedex 20
Country
France
Facility Name
1241.36.33008 Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
1241.36.33006 Boehringer Ingelheim Investigational Site
City
Saint Laurent du Var Cedex
Country
France
Facility Name
1241.36.33005 Boehringer Ingelheim Investigational Site
City
Toulouse
Country
France
Facility Name
1241.36.33007 Boehringer Ingelheim Investigational Site
City
Villejuif Cedex
Country
France
Facility Name
1241.36.49011 Boehringer Ingelheim Investigational Site
City
Aachen
Country
Germany
Facility Name
1241.36.49001 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1241.36.49012 Boehringer Ingelheim Investigational Site
City
Dortmund
Country
Germany
Facility Name
1241.36.49004 Boehringer Ingelheim Investigational Site
City
Düsseldorf
Country
Germany
Facility Name
1241.36.49008 Boehringer Ingelheim Investigational Site
City
Erlangen
Country
Germany
Facility Name
1241.36.49009 Boehringer Ingelheim Investigational Site
City
Esslingen
Country
Germany
Facility Name
1241.36.49014 Boehringer Ingelheim Investigational Site
City
Freiburg
Country
Germany
Facility Name
1241.36.49002 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
1241.36.49007 Boehringer Ingelheim Investigational Site
City
Mainz
Country
Germany
Facility Name
1241.36.49013 Boehringer Ingelheim Investigational Site
City
Tübingen
Country
Germany
Facility Name
1241.36.30001 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1241.36.30002 Boehringer Ingelheim Investigational Site
City
Athens
Country
Greece
Facility Name
1241.36.30003 Boehringer Ingelheim Investigational Site
City
Patras
Country
Greece
Facility Name
1241.36.30004 Boehringer Ingelheim Investigational Site
City
Rhodes
Country
Greece
Facility Name
1241.36.39025 Boehringer Ingelheim Investigational Site
City
Antella (fi)
Country
Italy
Facility Name
1241.36.39023 Boehringer Ingelheim Investigational Site
City
Bisceglie (bat)
Country
Italy
Facility Name
1241.36.39021 Boehringer Ingelheim Investigational Site
City
Bologna
Country
Italy
Facility Name
1241.36.39022 Boehringer Ingelheim Investigational Site
City
Milano
Country
Italy
Facility Name
1241.36.39020 Boehringer Ingelheim Investigational Site
City
Palermo
Country
Italy
Facility Name
1241.36.39026 Boehringer Ingelheim Investigational Site
City
Pavia
Country
Italy
Facility Name
1241.36.39028 Boehringer Ingelheim Investigational Site
City
Pescara
Country
Italy
Facility Name
1241.36.39029 Boehringer Ingelheim Investigational Site
City
Roma
Country
Italy
Facility Name
1241.36.39024 Boehringer Ingelheim Investigational Site
City
San Giovanni Rotondo (fg)
Country
Italy
Facility Name
1241.36.64001 Boehringer Ingelheim Investigational Site
City
Auckland NZ
Country
New Zealand
Facility Name
1241.36.64002 Boehringer Ingelheim Investigational Site
City
Hamilton
Country
New Zealand
Facility Name
1241.36.35103 Boehringer Ingelheim Investigational Site
City
Barreiro
Country
Portugal
Facility Name
1241.36.35104 Boehringer Ingelheim Investigational Site
City
Coimbra
Country
Portugal
Facility Name
1241.36.35101 Boehringer Ingelheim Investigational Site
City
Lisboa
Country
Portugal
Facility Name
1241.36.34006 Boehringer Ingelheim Investigational Site
City
Badalona (Barcelona)
Country
Spain
Facility Name
1241.36.34002 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1241.36.34004 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1241.36.34001 Boehringer Ingelheim Investigational Site
City
L'Hospitalet Llobregat (BCN)
Country
Spain
Facility Name
1241.36.34005 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1241.36.34008 Boehringer Ingelheim Investigational Site
City
Malaga
Country
Spain
Facility Name
1241.36.34003 Boehringer Ingelheim Investigational Site
City
Sevilla
Country
Spain
Facility Name
1241.36.34007 Boehringer Ingelheim Investigational Site
City
Vigo (Pontevedra)
Country
Spain
Facility Name
1241.36.44003 Boehringer Ingelheim Investigational Site
City
Birmingham
Country
United Kingdom
Facility Name
1241.36.44006 Boehringer Ingelheim Investigational Site
City
Edinburgh
Country
United Kingdom
Facility Name
1241.36.44011 Boehringer Ingelheim Investigational Site
City
Hull
Country
United Kingdom
Facility Name
1241.36.44013 Boehringer Ingelheim Investigational Site
City
Leeds
Country
United Kingdom
Facility Name
1241.36.44008 Boehringer Ingelheim Investigational Site
City
Leicester
Country
United Kingdom
Facility Name
1241.36.44001 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1241.36.44005 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1241.36.44007 Boehringer Ingelheim Investigational Site
City
Manchester
Country
United Kingdom
Facility Name
1241.36.44010 Boehringer Ingelheim Investigational Site
City
Newcastle upon Tyne
Country
United Kingdom
Facility Name
1241.36.44002 Boehringer Ingelheim Investigational Site
City
Oxford
Country
United Kingdom
Facility Name
1241.36.44004 Boehringer Ingelheim Investigational Site
City
Plymouth
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27920566
Citation
Sarrazin C, Castelli F, Andreone P, Buti M, Colombo M, Pol S, Calinas F, Puoti M, Olveira A, Shiffman M, Stern JO, Kukolj G, Roehrle M, Aslanyan S, Deng Q, Vinisko R, Mensa FJ, Nelson DR. HCVerso1 and 2: faldaprevir with deleobuvir (BI 207127) and ribavirin for treatment-naive patients with chronic hepatitis C virus genotype-1b infection. Clin Exp Gastroenterol. 2016 Nov 24;9:351-363. doi: 10.2147/CEG.S111116. eCollection 2016.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com
Description
Related Info

Learn more about this trial

Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2

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