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Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BI 207127
BI 201335
BI 207127
BI 201335
Ribavirin
Ribavirin
Ribavirin
BI 207127
BI 207127
BI 207127
BI 201335
Ribavirin
Ribavirin
BI 207127
BI 207127
BI 201335
BI 201335
Ribavirin
BI 201335
BI 201335
BI 207127
BI 201335
BI 201335
BI 207127
BI 201335
Ribavirin
Ribavirin
BI 207217
BI 201335
BI 207127
Ribavirin
BI 207127
BI 201335
Ribavirin
Ribavirin
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:

  • Chronic hepatitis C virus (HCV) infection of genotype (GT) 1
  • Parts 1-3:Treatment naive to Interferon -alfa (IFN), Pegylated interferon -alfa (PegIFN), ribavirin (RBV), and any direct acting antiviral agent for chronic hepatitis C
  • Part 4: Treatment experienced with confirmed prior virological failure to an approved dose of PegIFN/RBV (null-response)
  • HCV RNA >=10,000 IU/mL at screening
  • Liver biopsy within two years or fibroscan within six months prior to baseline
  • Liver biopsy within two years or fibroscan within 6 months prior to screening
  • Age 18-75 years

Exclusion criteria:

  • Hepatitis C virus (HCV) infection of mixed genotype
  • Evidence of liver disease due to causes other than chronic HCV infection
  • Positive ELISA for human immunodeficiency virus (HIV)
  • Hepatitis B virus (HBV) infection
  • Decompensated liver disease or history of decompensated liver disease
  • Active or suspected malignancy within the last 5 years
  • Ongoing or historical photosensitivity or recurrent rash
  • History of alcohol or drug abuse (except cannabis) within the past 12 months
  • Body mass index (BMI)I <18 or > 35 kg/m2
  • Usage of any investigational drugs within 30 days prior to enrolment, or 5 half-lives, whichever is longer; o the planned usage of an investigational drug during the course of the current study
  • Known hypersensitivity to any ingredient of the study drugs
  • A condition that is defined as one which in the opinion of the investigator may interfere with the patient's capability for participation in the trial or may influence the results of the trial
  • Alpha fetoprotein >100ng/mL at screening; if >20ng/mL and <=100ng/mL, patients can be included if there is no evidence of liver cancer in an appropriate imaging study within 6 months prior to randomisation
  • Total bilirubin > 2 mg/dL with ratio of direct/indirect > 1
  • AST or ALT >5xULN
  • INR prolonged to >1.7xULN
  • Requirement for chronic systemic corticosteroids
  • Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to enrolment or 5 half-lives, whichever is longer
  • Received silymarin or glycyrrhizin or Sho-saiko-to within 30 days prior to enrolment
  • Contraindications pertaining to PegIFN or RBV

Sites / Locations

  • 1241.21.0003 Boehringer Ingelheim Investigational Site
  • 1241.21.0006 Boehringer Ingelheim Investigational Site
  • 1241.21.0004 Boehringer Ingelheim Investigational Site
  • 1241.21.0011 Boehringer Ingelheim Investigational Site
  • 1241.21.0013 Boehringer Ingelheim Investigational Site
  • 1241.21.0008 Boehringer Ingelheim Investigational Site
  • 1241.21.0019 Boehringer Ingelheim Investigational Site
  • 1241.21.0012 Boehringer Ingelheim Investigational Site
  • 1241.21.0005 Boehringer Ingelheim Investigational Site
  • 1241.21.0007 Boehringer Ingelheim Investigational Site
  • 1241.21.0010 Boehringer Ingelheim Investigational Site
  • 1241.21.0017 Boehringer Ingelheim Investigational Site
  • 1241.21.61002 Boehringer Ingelheim Investigational Site
  • 1241.21.61001 Boehringer Ingelheim Investigational Site
  • 1241.21.43003 Boehringer Ingelheim Investigational Site
  • 1241.21.43001 Boehringer Ingelheim Investigational Site
  • 1241.21.43002 Boehringer Ingelheim Investigational Site
  • 1241.21.33005 Boehringer Ingelheim Investigational Site
  • 1241.21.33007 Boehringer Ingelheim Investigational Site
  • 1241.21.33003 Boehringer Ingelheim Investigational Site
  • 1241.21.33001 Boehringer Ingelheim Investigational Site
  • 1241.21.33002 Boehringer Ingelheim Investigational Site
  • 1241.21.33004 Boehringer Ingelheim Investigational Site
  • 1241.21.33008 Boehringer Ingelheim Investigational Site
  • 1241.21.33006 Boehringer Ingelheim Investigational Site
  • 1241.21.49002 Boehringer Ingelheim Investigational Site
  • 1241.21.49003 Boehringer Ingelheim Investigational Site
  • 1241.21.49007 Boehringer Ingelheim Investigational Site
  • 1241.21.49005 Boehringer Ingelheim Investigational Site
  • 1241.21.49001 Boehringer Ingelheim Investigational Site
  • 1241.21.49006 Boehringer Ingelheim Investigational Site
  • 1241.21.49009 Boehringer Ingelheim Investigational Site
  • 1241.21.49004 Boehringer Ingelheim Investigational Site
  • 1241.21.49008 Boehringer Ingelheim Investigational Site
  • 1241.21.64001 Boehringer Ingelheim Investigational Site
  • 1241.21.35103 Boehringer Ingelheim Investigational Site
  • 1241.21.35104 Boehringer Ingelheim Investigational Site
  • 1241.21.35101 Boehringer Ingelheim Investigational Site
  • 1241.21.35105 Boehringer Ingelheim Investigational Site
  • 1241.21.35102 Boehringer Ingelheim Investigational Site
  • 1241.21.40001 Boehringer Ingelheim Investigational Site
  • 1241.21.40002 Boehringer Ingelheim Investigational Site
  • 1241.21.40003 Boehringer Ingelheim Investigational Site
  • 1241.21.34002 Boehringer Ingelheim Investigational Site
  • 1241.21.34005 Boehringer Ingelheim Investigational Site
  • 1241.21.34003 Boehringer Ingelheim Investigational Site
  • 1241.21.34004 Boehringer Ingelheim Investigational Site
  • 1241.21.34001 Boehringer Ingelheim Investigational Site
  • 1241.21.34006 Boehringer Ingelheim Investigational Site
  • 1241.21.41003 Boehringer Ingelheim Investigational Site
  • 1241.21.41006 Boehringer Ingelheim Investigational Site
  • 1241.21.41001 Boehringer Ingelheim Investigational Site
  • 1241.21.41002 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

2

1

3

4

5

6

7

8

9

10

11

12

Arm Description

4 weeks of high dose TID BI 207127 and QD BI 201335 in combination with RBV, Part 1

4 weeks of low dose three times per day (TID) BI 207127 and once daily (QD) BI 201335 in combination with RBV, Part 1

16 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2

28 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2

40 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2

28 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 2

28 weeks of TID BI 207127 and QD BI 201335 without RBV, Part 2

16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3

24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3

24 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 3

16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4

24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4

Outcomes

Primary Outcome Measures

Part 1: Rapid Virological Response (RVR)
Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) <25IU/mL at Week 4 of treatment
Part 2: Sustained Virological Response (SVR)
Part 2: Sustained virological response (SVR), defined as HCV RNA <25 IU/mL and undetectable at 12 weeks after end of treatment
Part 3 and 4: Sustained Virological Response (SVR)
Part 3 and 4: Sustained virological response (SVR) defined as HCV RNA <25IU/mL and undetectable at 12 weeks after end of treatment

Secondary Outcome Measures

Part 1: Time to Virological Response
Part 1: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.
Part 2: Time to Virological Response
Part 2: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.
Part 1 and 2: Plasma HCV RNA Level Not Detectable at Week 4
Part 1 and 2: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level not detectable at Week 4
Part 2: Sustained Virological Response at 4 and 24 Weeks After End of Treatment
Part 2: Sustained virological response at 4 and 24 weeks after end of treatment
Part 3 and 4: Plasma HCV RNA Level <25 IU/mL at Week 4 and 12 of Treatment
Part 3 and 4: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level <25 IU/mL at week 4 and 12 of treatment
Part 3 and 4: Sustained Virological Response (SVR) at 4 Weeks After End of Treatment
Part 3 and 4: Sustained virological response (SVR) at 4 weeks after end of treatment

Full Information

First Posted
May 3, 2010
Last Updated
December 22, 2015
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT01132313
Brief Title
Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection
Official Title
Safety, Antiviral Effect and Pharmacokinetics of BI 207127 in Combination With BI 201335 and With or Without Ribavirin for 4, 16, 24, 28 or 40 Weeks in Patients With Chronic HCV Genotype 1 Infection (Randomized Phase Ib/II)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 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 substances BI 201335 and BI 207127 are being developed for the treatment of chronic hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from replicating. The currently available medications pegylated interferon alfa and ribavirin for hepatitis C ca have considerable adverse events in patients and in many cases are not sufficiently effective. This is particularly the case in treatment of patients infected with genotype 1 of HCV. A combination therapy of these new substances without pegylated interferon alfa may be associated with fewer adverse events that currently available (pegylated interferon-alfa-based) medication and may also provide a treatment option to the large number of patients with contraindications or intolerance to pegylated interferon alfa. This clinical trial (1241.21) currently consists of 3 distinct studies: Part 1, Part 2 and Part 3. Part 1 (SOUND-C1) is a 2 armed study as described in experimental arms 1 and 2 below (actual enrollment: 56 patients; randomized and treated: 32) Part 2 (SOUND-C2) is a 5 armed study as described in experimental arms 3 to 7 below (actual enrollment: 465; randomized and treated: 362) Part 3 (SOUND-C3) includes 3 arms as described in experimental arms 8 to 10 below (83 patients randomized and treated)

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 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
488 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Experimental
Arm Description
4 weeks of high dose TID BI 207127 and QD BI 201335 in combination with RBV, Part 1
Arm Title
1
Arm Type
Experimental
Arm Description
4 weeks of low dose three times per day (TID) BI 207127 and once daily (QD) BI 201335 in combination with RBV, Part 1
Arm Title
3
Arm Type
Experimental
Arm Description
16 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
Arm Title
4
Arm Type
Experimental
Arm Description
28 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
Arm Title
5
Arm Type
Experimental
Arm Description
40 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
Arm Title
6
Arm Type
Experimental
Arm Description
28 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 2
Arm Title
7
Arm Type
Experimental
Arm Description
28 weeks of TID BI 207127 and QD BI 201335 without RBV, Part 2
Arm Title
8
Arm Type
Experimental
Arm Description
16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3
Arm Title
9
Arm Type
Experimental
Arm Description
24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3
Arm Title
10
Arm Type
Experimental
Arm Description
24 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 3
Arm Title
11
Arm Type
Experimental
Arm Description
16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4
Arm Title
12
Arm Type
Experimental
Arm Description
24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4
Intervention Type
Drug
Intervention Name(s)
BI 207127
Intervention Description
28 weeks, high dose, TID
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
40 weeks, QD
Intervention Type
Drug
Intervention Name(s)
BI 207127
Intervention Description
4 weeks, low dose TID
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
24 weeks, QD
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
16 weeks, according to label
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
28 weeks, according to label
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
28 weeks, according to label
Intervention Type
Drug
Intervention Name(s)
BI 207127
Intervention Description
40 weeks, high dose, TID
Intervention Type
Drug
Intervention Name(s)
BI 207127
Intervention Description
24 weeks, very high dose, BID
Intervention Type
Drug
Intervention Name(s)
BI 207127
Intervention Description
16 weeks, standard dose, BID
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
24 weeks, QD
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
48 weeks, according to label
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
40 weeks, according to label
Intervention Type
Drug
Intervention Name(s)
BI 207127
Intervention Description
16 weeks, high dose, TID
Intervention Type
Drug
Intervention Name(s)
BI 207127
Intervention Description
28 weeks, high dose, TID
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
28 weeks, QD
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
16 weeks, QD
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
24 weeks, according to label
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
24 weeks, QD
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
28 weeks, QD
Intervention Type
Drug
Intervention Name(s)
BI 207127
Intervention Description
24 weeks, standard dose, BID
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
24 weeks, QD
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
16 weeks, QD
Intervention Type
Drug
Intervention Name(s)
BI 207127
Intervention Description
16 weeks, high dose, BID
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
24 weeks, QD
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
16 weeks, according to label
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
16 weeks, according to label
Intervention Type
Drug
Intervention Name(s)
BI 207217
Intervention Description
28 weeks, high dose BID
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
16 weeks, QD
Intervention Type
Drug
Intervention Name(s)
BI 207127
Intervention Description
24 weeks, high dose, TID
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
48 weeks, according to label
Intervention Type
Drug
Intervention Name(s)
BI 207127
Intervention Description
4 weeks, high dose, TID
Intervention Type
Drug
Intervention Name(s)
BI 201335
Intervention Description
28 weeks, QD
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
24 weeks, according to label
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
24 weeks, according to label
Primary Outcome Measure Information:
Title
Part 1: Rapid Virological Response (RVR)
Description
Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) <25IU/mL at Week 4 of treatment
Time Frame
4 weeks
Title
Part 2: Sustained Virological Response (SVR)
Description
Part 2: Sustained virological response (SVR), defined as HCV RNA <25 IU/mL and undetectable at 12 weeks after end of treatment
Time Frame
From drug administration until 12 weeks after end of treatment, up to 52 weeks
Title
Part 3 and 4: Sustained Virological Response (SVR)
Description
Part 3 and 4: Sustained virological response (SVR) defined as HCV RNA <25IU/mL and undetectable at 12 weeks after end of treatment
Time Frame
From drug administration until 12 weeks after end of treatment, up to 36 weeks
Secondary Outcome Measure Information:
Title
Part 1: Time to Virological Response
Description
Part 1: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.
Time Frame
From drug administration until end of drug administration, up to 4 weeks
Title
Part 2: Time to Virological Response
Description
Part 2: Time to virological response, defined as the timepoint of the first measurement of plasma HCV RNA level <25 IU/mL. The percentage of participants who achieved virological response within each time period are displayed for this outcome measure.
Time Frame
From drug administration until end of drug administration, up to 40 weeks
Title
Part 1 and 2: Plasma HCV RNA Level Not Detectable at Week 4
Description
Part 1 and 2: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level not detectable at Week 4
Time Frame
4 weeks
Title
Part 2: Sustained Virological Response at 4 and 24 Weeks After End of Treatment
Description
Part 2: Sustained virological response at 4 and 24 weeks after end of treatment
Time Frame
4 weeks and 24 weeks after the end of treatment, up to 64 weeks
Title
Part 3 and 4: Plasma HCV RNA Level <25 IU/mL at Week 4 and 12 of Treatment
Description
Part 3 and 4: Plasma Hepatitis C Virus Ribonucleic acid (HCV RNA) level <25 IU/mL at week 4 and 12 of treatment
Time Frame
Week 4 and 12
Title
Part 3 and 4: Sustained Virological Response (SVR) at 4 Weeks After End of Treatment
Description
Part 3 and 4: Sustained virological response (SVR) at 4 weeks after end of treatment
Time Frame
up to 28 weeks

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 virus (HCV) infection of genotype (GT) 1 Parts 1-3:Treatment naive to Interferon -alfa (IFN), Pegylated interferon -alfa (PegIFN), ribavirin (RBV), and any direct acting antiviral agent for chronic hepatitis C Part 4: Treatment experienced with confirmed prior virological failure to an approved dose of PegIFN/RBV (null-response) HCV RNA >=10,000 IU/mL at screening Liver biopsy within two years or fibroscan within six months prior to baseline Liver biopsy within two years or fibroscan within 6 months prior to screening Age 18-75 years Exclusion criteria: Hepatitis C virus (HCV) infection of mixed genotype Evidence of liver disease due to causes other than chronic HCV infection Positive ELISA for human immunodeficiency virus (HIV) Hepatitis B virus (HBV) infection Decompensated liver disease or history of decompensated liver disease Active or suspected malignancy within the last 5 years Ongoing or historical photosensitivity or recurrent rash History of alcohol or drug abuse (except cannabis) within the past 12 months Body mass index (BMI)I <18 or > 35 kg/m2 Usage of any investigational drugs within 30 days prior to enrolment, or 5 half-lives, whichever is longer; o the planned usage of an investigational drug during the course of the current study Known hypersensitivity to any ingredient of the study drugs A condition that is defined as one which in the opinion of the investigator may interfere with the patient's capability for participation in the trial or may influence the results of the trial Alpha fetoprotein >100ng/mL at screening; if >20ng/mL and <=100ng/mL, patients can be included if there is no evidence of liver cancer in an appropriate imaging study within 6 months prior to randomisation Total bilirubin > 2 mg/dL with ratio of direct/indirect > 1 AST or ALT >5xULN INR prolonged to >1.7xULN Requirement for chronic systemic corticosteroids Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to enrolment or 5 half-lives, whichever is longer Received silymarin or glycyrrhizin or Sho-saiko-to within 30 days prior to enrolment Contraindications pertaining to PegIFN or RBV
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
1241.21.0003 Boehringer Ingelheim Investigational Site
City
La Jolla
State/Province
California
Country
United States
Facility Name
1241.21.0006 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
1241.21.0004 Boehringer Ingelheim Investigational Site
City
San Francisco
State/Province
California
Country
United States
Facility Name
1241.21.0011 Boehringer Ingelheim Investigational Site
City
Palm Harbor
State/Province
Florida
Country
United States
Facility Name
1241.21.0013 Boehringer Ingelheim Investigational Site
City
Valparaiso
State/Province
Indiana
Country
United States
Facility Name
1241.21.0008 Boehringer Ingelheim Investigational Site
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
1241.21.0019 Boehringer Ingelheim Investigational Site
City
Fayetteville
State/Province
North Carolina
Country
United States
Facility Name
1241.21.0012 Boehringer Ingelheim Investigational Site
City
Arlington
State/Province
Texas
Country
United States
Facility Name
1241.21.0005 Boehringer Ingelheim Investigational Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
1241.21.0007 Boehringer Ingelheim Investigational Site
City
Dallas
State/Province
Texas
Country
United States
Facility Name
1241.21.0010 Boehringer Ingelheim Investigational Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
1241.21.0017 Boehringer Ingelheim Investigational Site
City
Seattle
State/Province
Washington
Country
United States
Facility Name
1241.21.61002 Boehringer Ingelheim Investigational Site
City
Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
1241.21.61001 Boehringer Ingelheim Investigational Site
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
1241.21.43003 Boehringer Ingelheim Investigational Site
City
Linz
Country
Austria
Facility Name
1241.21.43001 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1241.21.43002 Boehringer Ingelheim Investigational Site
City
Wien
Country
Austria
Facility Name
1241.21.33005 Boehringer Ingelheim Investigational Site
City
Clichy
Country
France
Facility Name
1241.21.33007 Boehringer Ingelheim Investigational Site
City
Grenoble cédex 9
Country
France
Facility Name
1241.21.33003 Boehringer Ingelheim Investigational Site
City
Lyon
Country
France
Facility Name
1241.21.33001 Boehringer Ingelheim Investigational Site
City
Marseille
Country
France
Facility Name
1241.21.33002 Boehringer Ingelheim Investigational Site
City
Montpellier
Country
France
Facility Name
1241.21.33004 Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
1241.21.33008 Boehringer Ingelheim Investigational Site
City
Paris
Country
France
Facility Name
1241.21.33006 Boehringer Ingelheim Investigational Site
City
Vandoeuvre Cedex
Country
France
Facility Name
1241.21.49002 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1241.21.49003 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1241.21.49007 Boehringer Ingelheim Investigational Site
City
Düsseldorf
Country
Germany
Facility Name
1241.21.49005 Boehringer Ingelheim Investigational Site
City
Esslingen
Country
Germany
Facility Name
1241.21.49001 Boehringer Ingelheim Investigational Site
City
Frankfurt am Main
Country
Germany
Facility Name
1241.21.49006 Boehringer Ingelheim Investigational Site
City
Hamburg
Country
Germany
Facility Name
1241.21.49009 Boehringer Ingelheim Investigational Site
City
Hannover
Country
Germany
Facility Name
1241.21.49004 Boehringer Ingelheim Investigational Site
City
Leipzig
Country
Germany
Facility Name
1241.21.49008 Boehringer Ingelheim Investigational Site
City
Mainz
Country
Germany
Facility Name
1241.21.64001 Boehringer Ingelheim Investigational Site
City
Auckland NZ
Country
New Zealand
Facility Name
1241.21.35103 Boehringer Ingelheim Investigational Site
City
Aveiro
Country
Portugal
Facility Name
1241.21.35104 Boehringer Ingelheim Investigational Site
City
Coimbra
Country
Portugal
Facility Name
1241.21.35101 Boehringer Ingelheim Investigational Site
City
Lisboa
Country
Portugal
Facility Name
1241.21.35105 Boehringer Ingelheim Investigational Site
City
Lisboa
Country
Portugal
Facility Name
1241.21.35102 Boehringer Ingelheim Investigational Site
City
Porto
Country
Portugal
Facility Name
1241.21.40001 Boehringer Ingelheim Investigational Site
City
Bucharest
Country
Romania
Facility Name
1241.21.40002 Boehringer Ingelheim Investigational Site
City
Bucharest
Country
Romania
Facility Name
1241.21.40003 Boehringer Ingelheim Investigational Site
City
Bucharest
Country
Romania
Facility Name
1241.21.34002 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1241.21.34005 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1241.21.34003 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1241.21.34004 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1241.21.34001 Boehringer Ingelheim Investigational Site
City
Majadahonda-Madrid
Country
Spain
Facility Name
1241.21.34006 Boehringer Ingelheim Investigational Site
City
Valencia
Country
Spain
Facility Name
1241.21.41003 Boehringer Ingelheim Investigational Site
City
Basel
Country
Switzerland
Facility Name
1241.21.41006 Boehringer Ingelheim Investigational Site
City
Bern
Country
Switzerland
Facility Name
1241.21.41001 Boehringer Ingelheim Investigational Site
City
St. Gallen
Country
Switzerland
Facility Name
1241.21.41002 Boehringer Ingelheim Investigational Site
City
Zürich
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
27140229
Citation
Zeuzem S, Mantry P, Soriano V, Buynak RJ, Dufour JF, Pockros PJ, Wright D, Angus P, Buti M, Stern JO, Kadus W, Vinisko R, Bocher W, Mensa FJ. Short article: Faldaprevir, deleobuvir and ribavirin in IL28B non-CC patients with HCV genotype-1a infection included in the SOUND-C3 phase 2b study. Eur J Gastroenterol Hepatol. 2016 Aug;28(8):923-6. doi: 10.1097/MEG.0000000000000649.
Results Reference
derived
PubMed Identifier
26650626
Citation
Asselah T, Zeuzem S, Soriano V, Bronowicki JP, Lohse AW, Mullhaupt B, Schuchmann M, Bourliere M, Buti M, Roberts SK, Gane EJ, Stern JO, Voss F, Baum P, Gallivan JP, Bocher WO, Mensa FJ. ITPA Genotypes Predict Anemia but Do Not Affect Virological Response with Interferon-Free Faldaprevir, Deleobuvir, and Ribavirin for HCV Infection. PLoS One. 2015 Dec 9;10(12):e0144004. doi: 10.1371/journal.pone.0144004. eCollection 2015.
Results Reference
derived
PubMed Identifier
25512403
Citation
Zeuzem S, Soriano V, Asselah T, Gane EJ, Bronowicki JP, Angus P, Lohse AW, Stickel F, Mullhaupt B, Roberts S, Schuchmann M, Manns M, Bourliere M, Buti M, Stern JO, Gallivan JP, Voss F, Sabo JP, Bocher W, Mensa FJ; SOUND-C2 Study Group. Efficacy and safety of faldaprevir, deleobuvir, and ribavirin in treatment-naive patients with chronic hepatitis C virus infection and advanced liver fibrosis or cirrhosis. Antimicrob Agents Chemother. 2015 Feb;59(2):1282-91. doi: 10.1128/AAC.04383-14. Epub 2014 Dec 15.
Results Reference
derived
PubMed Identifier
23944300
Citation
Zeuzem S, Soriano V, Asselah T, Bronowicki JP, Lohse AW, Mullhaupt B, Schuchmann M, Bourliere M, Buti M, Roberts SK, Gane EJ, Stern JO, Vinisko R, Kukolj G, Gallivan JP, Bocher WO, Mensa FJ. Faldaprevir and deleobuvir for HCV genotype 1 infection. N Engl J Med. 2013 Aug 15;369(7):630-9. doi: 10.1056/NEJMoa1213557.
Results Reference
derived
PubMed Identifier
23558093
Citation
Zeuzem S, Asselah T, Angus P, Zarski JP, Larrey D, Mullhaupt B, Gane E, Schuchmann M, Lohse AW, Pol S, Bronowicki JP, Roberts S, Arasteh K, Zoulim F, Heim M, Stern JO, Nehmiz G, Kukolj G, Bocher WO, Mensa FJ. Faldaprevir (BI 201335), deleobuvir (BI 207127) and ribavirin oral therapy for treatment-naive HCV genotype 1: SOUND-C1 final results. Antivir Ther. 2013;18(8):1015-9. doi: 10.3851/IMP2567. Epub 2013 Apr 4.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info

Learn more about this trial

Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection

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