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Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BI 201335
Pegylated Interferon-alpha (IFN)
Ribavirin (RBV)
Placebo
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 - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Chronic hepatitis C genotype 1 infection, diagnosed at least 6 months prior to screening
  2. Confirmed prior virological failure with an approved dose of PegIFN/RBV
  3. Age 18 to 70 years,
  4. HCV RNA (RiboNucleic Acid) = 1,000 IU/mL at screening,

Exclusion criteria:

  1. HCV infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) co-infection
  2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection,
  3. Decompensated liver disease, or history of decompensated liver disease,
  4. Body weight < 40 or > 125 kg,
  5. Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder
  6. Pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study
  7. Laboratory parameters disorders (thalassemia major, sickle cell anemia or G6PD deficit)
  8. Hemoglobin < 12 g/dL for women and < 13 g/dL for men
  9. Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors,

Sites / Locations

  • 1220.7.0091 Boehringer Ingelheim Investigational Site
  • 1220.7.0082 Boehringer Ingelheim Investigational Site
  • 1220.7.0095 Boehringer Ingelheim Investigational Site
  • 1220.7.0039 Boehringer Ingelheim Investigational Site
  • 1220.7.0013 Boehringer Ingelheim Investigational Site
  • 1220.7.0062 Boehringer Ingelheim Investigational Site
  • 1220.7.0085 Boehringer Ingelheim Investigational Site
  • 1220.7.0087 Boehringer Ingelheim Investigational Site
  • 1220.7.0101 Boehringer Ingelheim Investigational Site
  • 1220.7.0027 Boehringer Ingelheim Investigational Site
  • 1220.7.0012 Boehringer Ingelheim Investigational Site
  • 1220.7.0077 Boehringer Ingelheim Investigational Site
  • 1220.7.0058 Boehringer Ingelheim Investigational Site
  • 1220.7.0063 Boehringer Ingelheim Investigational Site
  • 1220.7.0029 Boehringer Ingelheim Investigational Site
  • 1220.7.0071 Boehringer Ingelheim Investigational Site
  • 1220.7.0009 Boehringer Ingelheim Investigational Site
  • 1220.7.0016 Boehringer Ingelheim Investigational Site
  • 1220.7.4303 Boehringer Ingelheim Investigational Site
  • 1220.7.4301 Boehringer Ingelheim Investigational Site
  • 1220.7.4302 Boehringer Ingelheim Investigational Site
  • 1220.7.3201 Boehringer Ingelheim Investigational Site
  • 1220.7.3207 Boehringer Ingelheim Investigational Site
  • 1220.7.3204 Boehringer Ingelheim Investigational Site
  • 1220.7.3205 Boehringer Ingelheim Investigational Site
  • 1220.7.3206 Boehringer Ingelheim Investigational Site
  • 1220.7.3202 Boehringer Ingelheim Investigational Site
  • 1220.7.3203 Boehringer Ingelheim Investigational Site
  • 1220.7.1011 Boehringer Ingelheim Investigational Site
  • 1220.7.1012 Boehringer Ingelheim Investigational Site
  • 1220.7.1003 Boehringer Ingelheim Investigational Site
  • 1220.7.1016 Boehringer Ingelheim Investigational Site
  • 1220.7.1007 Boehringer Ingelheim Investigational Site
  • 1220.7.1004 Boehringer Ingelheim Investigational Site
  • 1220.7.1006 Boehringer Ingelheim Investigational Site
  • 1220.7.1010 Boehringer Ingelheim Investigational Site
  • 1220.7.1014 Boehringer Ingelheim Investigational Site
  • 1220.7.3301 Boehringer Ingelheim Investigational Site
  • 1220.7.3311 Boehringer Ingelheim Investigational Site
  • 1220.7.3303 Boehringer Ingelheim Investigational Site
  • 1220.7.3304 Boehringer Ingelheim Investigational Site
  • 1220.7.3305 Boehringer Ingelheim Investigational Site
  • 1220.7.3302 Boehringer Ingelheim Investigational Site
  • 1220.7.3310 Boehringer Ingelheim Investigational Site
  • 1220.7.3316 Boehringer Ingelheim Investigational Site
  • 1220.7.3317 Boehringer Ingelheim Investigational Site
  • 1220.7.3315 Boehringer Ingelheim Investigational Site
  • 1220.7.3318 Boehringer Ingelheim Investigational Site
  • 1220.7.3308 Boehringer Ingelheim Investigational Site
  • 1220.7.4902 Boehringer Ingelheim Investigational Site
  • 1220.7.4904 Boehringer Ingelheim Investigational Site
  • 1220.7.4913 Boehringer Ingelheim Investigational Site
  • 1220.7.4906 Boehringer Ingelheim Investigational Site
  • 1220.7.4901 Boehringer Ingelheim Investigational Site
  • 1220.7.4908 Boehringer Ingelheim Investigational Site
  • 1220.7.4918 Boehringer Ingelheim Investigational Site
  • 1220.7.4907 Boehringer Ingelheim Investigational Site
  • 1220.7.4903 Boehringer Ingelheim Investigational Site
  • 1220.7.4911 Boehringer Ingelheim Investigational Site
  • 1220.7.4905 Boehringer Ingelheim Investigational Site
  • 1220.7.8106 Boehringer Ingelheim Investigational Site
  • 1220.7.8111 Boehringer Ingelheim Investigational Site
  • 1220.7.8107 Boehringer Ingelheim Investigational Site
  • 1220.7.8112 Boehringer Ingelheim Investigational Site
  • 1220.7.8108 Boehringer Ingelheim Investigational Site
  • 1220.7.8117 Boehringer Ingelheim Investigational Site
  • 1220.7.8109 Boehringer Ingelheim Investigational Site
  • 1220.7.8116 Boehringer Ingelheim Investigational Site
  • 1220.7.8118 Boehringer Ingelheim Investigational Site
  • 1220.7.8110 Boehringer Ingelheim Investigational Site
  • 1220.7.8124 Boehringer Ingelheim Investigational Site
  • 1220.7.8113 Boehringer Ingelheim Investigational Site
  • 1220.7.8105 Boehringer Ingelheim Investigational Site
  • 1220.7.8114 Boehringer Ingelheim Investigational Site
  • 1220.7.8125 Boehringer Ingelheim Investigational Site
  • 1220.7.8119 Boehringer Ingelheim Investigational Site
  • 1220.7.8122 Boehringer Ingelheim Investigational Site
  • 1220.7.8121 Boehringer Ingelheim Investigational Site
  • 1220.7.8101 Boehringer Ingelheim Investigational Site
  • 1220.7.8102 Boehringer Ingelheim Investigational Site
  • 1220.7.8115 Boehringer Ingelheim Investigational Site
  • 1220.7.8123 Boehringer Ingelheim Investigational Site
  • 1220.7.8126 Boehringer Ingelheim Investigational Site
  • 1220.7.8104 Boehringer Ingelheim Investigational Site
  • 1220.7.3503 Boehringer Ingelheim Investigational Site
  • 1220.7.3509 Boehringer Ingelheim Investigational Site
  • 1220.7.3506 Boehringer Ingelheim Investigational Site
  • 1220.7.3501 Boehringer Ingelheim Investigational Site
  • 1220.7.3505 Boehringer Ingelheim Investigational Site
  • 1220.7.3502 Boehringer Ingelheim Investigational Site
  • 1220.7.0034 Boehringer Ingelheim Investigational Site
  • 1220.7.3406 Boehringer Ingelheim Investigational Site
  • 1220.7.3402 Boehringer Ingelheim Investigational Site
  • 1220.7.3404 Boehringer Ingelheim Investigational Site
  • 1220.7.3411 Boehringer Ingelheim Investigational Site
  • 1220.7.3412 Boehringer Ingelheim Investigational Site
  • 1220.7.3405 Boehringer Ingelheim Investigational Site
  • 1220.7.3409 Boehringer Ingelheim Investigational Site
  • 1220.7.3410 Boehringer Ingelheim Investigational Site
  • 1220.7.3408 Boehringer Ingelheim Investigational Site
  • 1220.7.3403 Boehringer Ingelheim Investigational Site
  • 1220.7.3401 Boehringer Ingelheim Investigational Site
  • 1220.7.3407 Boehringer Ingelheim Investigational Site
  • 1220.7.4106 Boehringer Ingelheim Investigational Site
  • 1220.7.4103 Boehringer Ingelheim Investigational Site
  • 1220.7.4107 Boehringer Ingelheim Investigational Site
  • 1220.7.4108 Boehringer Ingelheim Investigational Site
  • 1220.7.4101 Boehringer Ingelheim Investigational Site
  • 1220.7.4405 Boehringer Ingelheim Investigational Site
  • 1220.7.4404 Boehringer Ingelheim Investigational Site
  • 1220.7.4409 Boehringer Ingelheim Investigational Site
  • 1220.7.4410 Boehringer Ingelheim Investigational Site
  • 1220.7.4401 Boehringer Ingelheim Investigational Site
  • 1220.7.4408 Boehringer Ingelheim Investigational Site
  • 1220.7.4407 Boehringer Ingelheim Investigational Site
  • 1220.7.4403 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Placebo/PegIFN/RBV

BI201335 12 weeks

BI201335 24 weeks

Arm Description

patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks

patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks

patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks

Outcomes

Primary Outcome Measures

Sustained Virological Response 12 Weeks Post Treatment (SVR12)
Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.

Secondary Outcome Measures

Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)
Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.
Early Treatment Success (ETS)
Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level <25 IU/mL (undetected or detected) at Week 4 and <25 IU/mL (undetected) at Week 8.
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO
The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment (EoT) when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES
The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO
The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES
The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment (EoT) when patients have sustained virological response 12 weeks post treatment. BL=baseline
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO
The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES
The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO
The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES
The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline

Full Information

First Posted
May 23, 2011
Last Updated
July 28, 2016
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT01358864
Brief Title
Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)
Official Title
A Phase III, Randomised, Double-blind and Placebo Controlled Study of Once Daily BI 201335, 240 mg for 12 or 24 Weeks in Combination With Pegylated interferon-a (PegIFNa) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN/RBV Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
May 2014 (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 this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.

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
ParticipantInvestigator
Allocation
Randomized
Enrollment
678 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo/PegIFN/RBV
Arm Type
Active Comparator
Arm Description
patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
Arm Title
BI201335 12 weeks
Arm Type
Experimental
Arm Description
patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks
Arm Title
BI201335 24 weeks
Arm Type
Experimental
Arm Description
patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
BI 201335 once a day (QD) for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Pegylated Interferon-alpha (IFN)
Intervention Description
Pegylated Interferon-alpha for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin (RBV)
Intervention Description
Ribavirin (RBV) for 24 or 48 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to BI201335 for 24 weeks
Primary Outcome Measure Information:
Title
Sustained Virological Response 12 Weeks Post Treatment (SVR12)
Description
Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
Time Frame
12 weeks post treatment, up to 60 weeks
Secondary Outcome Measure Information:
Title
Virological Response After 24 Weeks of Treatment Discontinuation (SVR24)
Description
Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.
Time Frame
24 weeks post treatment, up to 72 weeks
Title
Early Treatment Success (ETS)
Description
Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level <25 IU/mL (undetected or detected) at Week 4 and <25 IU/mL (undetected) at Week 8.
Time Frame
Week 4 and Week 8
Title
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO
Description
The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment (EoT) when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame
End of treatment, up to 48 weeks
Title
ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES
Description
The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame
End of treatment, up to 48 weeks
Title
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO
Description
The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame
End of treatment, up to 48 weeks
Title
AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES
Description
The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment (EoT) when patients have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame
End of treatment, up to 48 weeks
Title
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO
Description
The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame
12 weeks post treatment, up to 60 weeks
Title
ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES
Description
The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame
12 weeks post treatment, up to 60 weeks
Title
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO
Description
The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame
12 weeks post treatment, up to 60 weeks
Title
AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES
Description
The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
Time Frame
12 weeks post treatment, up to 60 weeks

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 infection, diagnosed at least 6 months prior to screening Confirmed prior virological failure with an approved dose of PegIFN/RBV Age 18 to 70 years, HCV RNA (RiboNucleic Acid) = 1,000 IU/mL at screening, Exclusion criteria: HCV infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) co-infection Evidence of acute or chronic liver disease due to causes other than chronic HCV infection, Decompensated liver disease, or history of decompensated liver disease, Body weight < 40 or > 125 kg, Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder Pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study Laboratory parameters disorders (thalassemia major, sickle cell anemia or G6PD deficit) Hemoglobin < 12 g/dL for women and < 13 g/dL for men Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors,
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
1220.7.0091 Boehringer Ingelheim Investigational Site
City
North Little Rock
State/Province
Arkansas
Country
United States
Facility Name
1220.7.0082 Boehringer Ingelheim Investigational Site
City
Englewood
State/Province
Colorado
Country
United States
Facility Name
1220.7.0095 Boehringer Ingelheim Investigational Site
City
Palm Harbor
State/Province
Florida
Country
United States
Facility Name
1220.7.0039 Boehringer Ingelheim Investigational Site
City
Columbus
State/Province
Georgia
Country
United States
Facility Name
1220.7.0013 Boehringer Ingelheim Investigational Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
1220.7.0062 Boehringer Ingelheim Investigational Site
City
Vaiparaiso
State/Province
Indiana
Country
United States
Facility Name
1220.7.0085 Boehringer Ingelheim Investigational Site
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
1220.7.0087 Boehringer Ingelheim Investigational Site
City
Baton Rouge
State/Province
Louisiana
Country
United States
Facility Name
1220.7.0101 Boehringer Ingelheim Investigational Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
1220.7.0027 Boehringer Ingelheim Investigational Site
City
Framingham
State/Province
Massachusetts
Country
United States
Facility Name
1220.7.0012 Boehringer Ingelheim Investigational Site
City
New York
State/Province
New York
Country
United States
Facility Name
1220.7.0077 Boehringer Ingelheim Investigational Site
City
Winston-Salem
State/Province
North Carolina
Country
United States
Facility Name
1220.7.0058 Boehringer Ingelheim Investigational Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
1220.7.0063 Boehringer Ingelheim Investigational Site
City
Arlington
State/Province
Texas
Country
United States
Facility Name
1220.7.0029 Boehringer Ingelheim Investigational Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
1220.7.0071 Boehringer Ingelheim Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
1220.7.0009 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1220.7.0016 Boehringer Ingelheim Investigational Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
1220.7.4303 Boehringer Ingelheim Investigational Site
City
Linz
Country
Austria
Facility Name
1220.7.4301 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1220.7.4302 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1220.7.3201 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
1220.7.3207 Boehringer Ingelheim Investigational Site
City
Bruxelles
Country
Belgium
Facility Name
1220.7.3204 Boehringer Ingelheim Investigational Site
City
Edegem
Country
Belgium
Facility Name
1220.7.3205 Boehringer Ingelheim Investigational Site
City
Gent
Country
Belgium
Facility Name
1220.7.3206 Boehringer Ingelheim Investigational Site
City
Jette
Country
Belgium
Facility Name
1220.7.3202 Boehringer Ingelheim Investigational Site
City
Leuven
Country
Belgium
Facility Name
1220.7.3203 Boehringer Ingelheim Investigational Site
City
Liège
Country
Belgium
Facility Name
1220.7.1011 Boehringer Ingelheim Investigational Site
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
1220.7.1012 Boehringer Ingelheim Investigational Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
1220.7.1003 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1220.7.1016 Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
1220.7.1007 Boehringer Ingelheim Investigational Site
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
1220.7.1004 Boehringer Ingelheim Investigational Site
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
1220.7.1006 Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
1220.7.1010 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1220.7.1014 Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
1220.7.3301 Boehringer Ingelheim Investigational Site
City
Clichy
Country
France
Facility Name
1220.7.3311 Boehringer Ingelheim Investigational Site
City
Lille
Country
France
Facility Name
1220.7.3303 Boehringer Ingelheim Investigational Site
City
Marseille
Country
France
Facility Name
1220.7.3304 Boehringer Ingelheim Investigational Site
City
Montpellier
Country
France
Facility Name
1220.7.3305 Boehringer Ingelheim Investigational Site
City
Nice Cedex 3
Country
France
Facility Name
1220.7.3302 Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
1220.7.3310 Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
1220.7.3316 Boehringer Ingelheim Investigational Site
City
Pessac Cedex
Country
France
Facility Name
1220.7.3317 Boehringer Ingelheim Investigational Site
City
Reims
Country
France
Facility Name
1220.7.3315 Boehringer Ingelheim Investigational Site
City
Rennes Cedex 09
Country
France
Facility Name
1220.7.3318 Boehringer Ingelheim Investigational Site
City
Strasbourg
Country
France
Facility Name
1220.7.3308 Boehringer Ingelheim Investigational Site
City
Vandoeuvre Cedex
Country
France
Facility Name
1220.7.4902 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1220.7.4904 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1220.7.4913 Boehringer Ingelheim Investigational Site
City
Dortmund
Country
Germany
Facility Name
1220.7.4906 Boehringer Ingelheim Investigational Site
City
Düsseldorf
Country
Germany
Facility Name
1220.7.4901 Boehringer Ingelheim Investigational Site
City
Frankfurt am Main
Country
Germany
Facility Name
1220.7.4908 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
1220.7.4918 Boehringer Ingelheim Investigational Site
City
Hannover
Country
Germany
Facility Name
1220.7.4907 Boehringer Ingelheim Investigational Site
City
Herne
Country
Germany
Facility Name
1220.7.4903 Boehringer Ingelheim Investigational Site
City
Leipzig
Country
Germany
Facility Name
1220.7.4911 Boehringer Ingelheim Investigational Site
City
Mainz
Country
Germany
Facility Name
1220.7.4905 Boehringer Ingelheim Investigational Site
City
München
Country
Germany
Facility Name
1220.7.8106 Boehringer Ingelheim Investigational Site
City
Chiba, Chiba
Country
Japan
Facility Name
1220.7.8111 Boehringer Ingelheim Investigational Site
City
Gifu, Gifu
Country
Japan
Facility Name
1220.7.8107 Boehringer Ingelheim Investigational Site
City
Itabashi-ku, Tokyo
Country
Japan
Facility Name
1220.7.8112 Boehringer Ingelheim Investigational Site
City
Izunokuni, Shizuoka
Country
Japan
Facility Name
1220.7.8108 Boehringer Ingelheim Investigational Site
City
Kamakura, Kanagawa
Country
Japan
Facility Name
1220.7.8117 Boehringer Ingelheim Investigational Site
City
Kita-gun, Kagawa
Country
Japan
Facility Name
1220.7.8109 Boehringer Ingelheim Investigational Site
City
Kofu, Yamanashi
Country
Japan
Facility Name
1220.7.8116 Boehringer Ingelheim Investigational Site
City
Kurashiki, Okayama
Country
Japan
Facility Name
1220.7.8118 Boehringer Ingelheim Investigational Site
City
Kurume, Fukuoka
Country
Japan
Facility Name
1220.7.8110 Boehringer Ingelheim Investigational Site
City
Matsumoto, Nagano
Country
Japan
Facility Name
1220.7.8124 Boehringer Ingelheim Investigational Site
City
Matsuyama, Ehime
Country
Japan
Facility Name
1220.7.8113 Boehringer Ingelheim Investigational Site
City
Nagoya, Aichi
Country
Japan
Facility Name
1220.7.8105 Boehringer Ingelheim Investigational Site
City
Namegata, Ibaraki
Country
Japan
Facility Name
1220.7.8114 Boehringer Ingelheim Investigational Site
City
Nishinomiya, Hyogo
Country
Japan
Facility Name
1220.7.8125 Boehringer Ingelheim Investigational Site
City
Ogaki, Gifu
Country
Japan
Facility Name
1220.7.8119 Boehringer Ingelheim Investigational Site
City
Omura, Nagasaki
Country
Japan
Facility Name
1220.7.8122 Boehringer Ingelheim Investigational Site
City
Omuta, Fukuoka
Country
Japan
Facility Name
1220.7.8121 Boehringer Ingelheim Investigational Site
City
Osaka, Osaka
Country
Japan
Facility Name
1220.7.8101 Boehringer Ingelheim Investigational Site
City
Sapporo, Hokkaido
Country
Japan
Facility Name
1220.7.8102 Boehringer Ingelheim Investigational Site
City
Sendai, Miyagi
Country
Japan
Facility Name
1220.7.8115 Boehringer Ingelheim Investigational Site
City
Tanabe, Wakayama
Country
Japan
Facility Name
1220.7.8123 Boehringer Ingelheim Investigational Site
City
Toyama,Toyama
Country
Japan
Facility Name
1220.7.8126 Boehringer Ingelheim Investigational Site
City
Tsu, Mie
Country
Japan
Facility Name
1220.7.8104 Boehringer Ingelheim Investigational Site
City
Tsuchiura, Ibaraki
Country
Japan
Facility Name
1220.7.3503 Boehringer Ingelheim Investigational Site
City
Aveiro
Country
Portugal
Facility Name
1220.7.3509 Boehringer Ingelheim Investigational Site
City
Barreiro
Country
Portugal
Facility Name
1220.7.3506 Boehringer Ingelheim Investigational Site
City
Coimbra
Country
Portugal
Facility Name
1220.7.3501 Boehringer Ingelheim Investigational Site
City
Lisboa
Country
Portugal
Facility Name
1220.7.3505 Boehringer Ingelheim Investigational Site
City
Lisboa
Country
Portugal
Facility Name
1220.7.3502 Boehringer Ingelheim Investigational Site
City
Porto
Country
Portugal
Facility Name
1220.7.0034 Boehringer Ingelheim Investigational Site
City
San Juan
Country
Puerto Rico
Facility Name
1220.7.3406 Boehringer Ingelheim Investigational Site
City
A Coruña
Country
Spain
Facility Name
1220.7.3402 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1220.7.3404 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1220.7.3411 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1220.7.3412 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1220.7.3405 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1220.7.3409 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1220.7.3410 Boehringer Ingelheim Investigational Site
City
Majadahonda-Madrid
Country
Spain
Facility Name
1220.7.3408 Boehringer Ingelheim Investigational Site
City
Santander
Country
Spain
Facility Name
1220.7.3403 Boehringer Ingelheim Investigational Site
City
Sevilla
Country
Spain
Facility Name
1220.7.3401 Boehringer Ingelheim Investigational Site
City
Valencia
Country
Spain
Facility Name
1220.7.3407 Boehringer Ingelheim Investigational Site
City
Vigo (Pontevedra)
Country
Spain
Facility Name
1220.7.4106 Boehringer Ingelheim Investigational Site
City
Bern
Country
Switzerland
Facility Name
1220.7.4103 Boehringer Ingelheim Investigational Site
City
La Chaux-de-Fonds
Country
Switzerland
Facility Name
1220.7.4107 Boehringer Ingelheim Investigational Site
City
Lugano
Country
Switzerland
Facility Name
1220.7.4108 Boehringer Ingelheim Investigational Site
City
St. Gallen
Country
Switzerland
Facility Name
1220.7.4101 Boehringer Ingelheim Investigational Site
City
Zürich
Country
Switzerland
Facility Name
1220.7.4405 Boehringer Ingelheim Investigational Site
City
Bristol
Country
United Kingdom
Facility Name
1220.7.4404 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1220.7.4409 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1220.7.4410 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom
Facility Name
1220.7.4401 Boehringer Ingelheim Investigational Site
City
Manchester
Country
United Kingdom
Facility Name
1220.7.4408 Boehringer Ingelheim Investigational Site
City
Nottingham
Country
United Kingdom
Facility Name
1220.7.4407 Boehringer Ingelheim Investigational Site
City
Oxford
Country
United Kingdom
Facility Name
1220.7.4403 Boehringer Ingelheim Investigational Site
City
Southampton
Country
United Kingdom

12. IPD Sharing Statement

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http://trials.boehringer-ingelheim.com/
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Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)

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