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BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ribavirin
BI 207127 high dose
Faldaprevir
Ribavirin
BI 207127 low dose
Faldaprevir
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. Treatment naïve and treatment experienced patients (prior relapse, interferon intolerant, and [allowed in Cohort A only] prior partial response).
  2. Chronic HCV infection of genotype 1 (GT1), sub-GT1b virus only.
  3. Liver cirrhosis defined as Metavir Grade=4 or Ishak Grade =5 on liver biopsy or liver stiffness of =13 kPa on fibroscan.

Exclusion criteria:

  1. HCV infection of mixed genotype (1/2, 1/3, and 1/4) or mixed sub-GT1a/1b or undefined diagnosed by genotypic testing at screening
  2. Liver disease due to causes other than chronic HCV infection which may include but is not limited to hemochromatosis, Wilson's disease, or autoimmune liver diseases.
  3. HIV infection
  4. Patients who have been previously treated with an investigational or approved DAA

Sites / Locations

  • 1241.30.10003 Boehringer Ingelheim Investigational Site
  • 1241.30.10007 Boehringer Ingelheim Investigational Site
  • 1241.30.10001 Boehringer Ingelheim Investigational Site
  • 1241.30.10012 Boehringer Ingelheim Investigational Site
  • 1241.30.10011 Boehringer Ingelheim Investigational Site
  • 1241.30.10002 Boehringer Ingelheim Investigational Site
  • 1241.30.49002 Boehringer Ingelheim Investigational Site
  • 1241.30.49004 Boehringer Ingelheim Investigational Site
  • 1241.30.49005 Boehringer Ingelheim Investigational Site
  • 1241.30.49008 Boehringer Ingelheim Investigational Site
  • 1241.30.49006 Boehringer Ingelheim Investigational Site
  • 1241.30.49001 Boehringer Ingelheim Investigational Site
  • 1241.30.49003 Boehringer Ingelheim Investigational Site
  • 1241.30.49007 Boehringer Ingelheim Investigational Site
  • 1241.30.34002 Boehringer Ingelheim Investigational Site
  • 1241.30.34005 Boehringer Ingelheim Investigational Site
  • 1241.30.34003 Boehringer Ingelheim Investigational Site
  • 1241.30.34001 Boehringer Ingelheim Investigational Site
  • 1241.30.44002 Boehringer Ingelheim Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

cohort A CPA

cohort A CPB

Arm Description

Cohort A CPA BI 207127/QD Faldaprevir Ribavirin

Cohort B CPB BI 207127/QD Faldaprevir Ribavirin

Outcomes

Primary Outcome Measures

SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT)
Sustained virologic response (SVR) at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) at 12 weeks after EOT. SVR12 was analyzed in a descriptive manner using percentage.

Secondary Outcome Measures

SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT)
Sustained virologic response (SVR) at Week 4 post-treatment (SVR4): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL at 4 weeks after EOT. SVR4 was analyzed in a descriptive manner using percentage.

Full Information

First Posted
March 22, 2013
Last Updated
October 20, 2015
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT01830127
Brief Title
BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3
Official Title
A Phase IIb Open Label Study of BI 207127 in Combination With Faldaprevir and Ribavirin in Patients With Moderate Hepatic Impairment (Child-Pugh B) With Genotype 1b Chronic Hepatitis C Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (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
To assess the pharmacokenetic characteristics of 600 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with mild hepatic impairment (CPA) (Arm 1) versus 400 mg BID BI 207127 / 120 mg QD faldaprevir /ribavirin in a small number of GT1b HCV infected patients with moderate hepatic impairment (CPB) (Arm 2).

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
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cohort A CPA
Arm Type
Experimental
Arm Description
Cohort A CPA BI 207127/QD Faldaprevir Ribavirin
Arm Title
cohort A CPB
Arm Type
Experimental
Arm Description
Cohort B CPB BI 207127/QD Faldaprevir Ribavirin
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
24 Weeks
Intervention Type
Drug
Intervention Name(s)
BI 207127 high dose
Intervention Description
24 Weeks
Intervention Type
Drug
Intervention Name(s)
Faldaprevir
Intervention Description
24 Weeks
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
24 Weeks
Intervention Type
Drug
Intervention Name(s)
BI 207127 low dose
Intervention Description
24 Weeks
Intervention Type
Drug
Intervention Name(s)
Faldaprevir
Intervention Description
24 Weeks
Primary Outcome Measure Information:
Title
SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT)
Description
Sustained virologic response (SVR) at Week 12 post-treatment (SVR12): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL(international units per millilitre) at 12 weeks after EOT. SVR12 was analyzed in a descriptive manner using percentage.
Time Frame
12 weeks after End of Treatment
Secondary Outcome Measure Information:
Title
SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT)
Description
Sustained virologic response (SVR) at Week 4 post-treatment (SVR4): Plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL at 4 weeks after EOT. SVR4 was analyzed in a descriptive manner using percentage.
Time Frame
4 weeks after End of 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: Treatment naïve and treatment experienced patients (prior relapse, interferon intolerant, and [allowed in Cohort A only] prior partial response). Chronic HCV infection of genotype 1 (GT1), sub-GT1b virus only. Liver cirrhosis defined as Metavir Grade=4 or Ishak Grade =5 on liver biopsy or liver stiffness of =13 kPa on fibroscan. Exclusion criteria: HCV infection of mixed genotype (1/2, 1/3, and 1/4) or mixed sub-GT1a/1b or undefined diagnosed by genotypic testing at screening Liver disease due to causes other than chronic HCV infection which may include but is not limited to hemochromatosis, Wilson's disease, or autoimmune liver diseases. HIV infection Patients who have been previously treated with an investigational or approved DAA
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
1241.30.10003 Boehringer Ingelheim Investigational Site
City
La Mesa
State/Province
California
Country
United States
Facility Name
1241.30.10007 Boehringer Ingelheim Investigational Site
City
San Diego
State/Province
California
Country
United States
Facility Name
1241.30.10001 Boehringer Ingelheim Investigational Site
City
Deland
State/Province
Florida
Country
United States
Facility Name
1241.30.10012 Boehringer Ingelheim Investigational Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
1241.30.10011 Boehringer Ingelheim Investigational Site
City
Arlington
State/Province
Texas
Country
United States
Facility Name
1241.30.10002 Boehringer Ingelheim Investigational Site
City
Norfolk
State/Province
Virginia
Country
United States
Facility Name
1241.30.49002 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1241.30.49004 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1241.30.49005 Boehringer Ingelheim Investigational Site
City
Berlin
Country
Germany
Facility Name
1241.30.49008 Boehringer Ingelheim Investigational Site
City
Bonn
Country
Germany
Facility Name
1241.30.49006 Boehringer Ingelheim Investigational Site
City
Frankfurt am Main
Country
Germany
Facility Name
1241.30.49001 Boehringer Ingelheim Investigational Site
City
Hannover
Country
Germany
Facility Name
1241.30.49003 Boehringer Ingelheim Investigational Site
City
Leipzig
Country
Germany
Facility Name
1241.30.49007 Boehringer Ingelheim Investigational Site
City
Mainz
Country
Germany
Facility Name
1241.30.34002 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1241.30.34005 Boehringer Ingelheim Investigational Site
City
Barcelona
Country
Spain
Facility Name
1241.30.34003 Boehringer Ingelheim Investigational Site
City
Madrid
Country
Spain
Facility Name
1241.30.34001 Boehringer Ingelheim Investigational Site
City
Majadahonda (Madrid)
Country
Spain
Facility Name
1241.30.44002 Boehringer Ingelheim Investigational Site
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
28030579
Citation
Sarrazin C, Manns M, Calleja JL, Garcia-Samaniego J, Forns X, Kaste R, Bai X, Wu J, Stern JO. HCVerso3: An Open-Label, Phase IIb Study of Faldaprevir and Deleobuvir with Ribavirin in Hepatitis C Virus Genotype-1b-Infected Patients with Cirrhosis and Moderate Hepatic Impairment. PLoS One. 2016 Dec 28;11(12):e0168544. doi: 10.1371/journal.pone.0168544. eCollection 2016.
Results Reference
derived
Links:
URL
http://trials.boehringer-ingelheim.com/
Description
Related Info

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BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3

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