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

October 20, 2015 updated by: Boehringer Ingelheim

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • 1241.30.49002 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1241.30.49004 Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • 1241.30.49005 Boehringer Ingelheim Investigational Site
      • Bonn, Germany
        • 1241.30.49008 Boehringer Ingelheim Investigational Site
      • Frankfurt am Main, Germany
        • 1241.30.49006 Boehringer Ingelheim Investigational Site
      • Hannover, Germany
        • 1241.30.49001 Boehringer Ingelheim Investigational Site
      • Leipzig, Germany
        • 1241.30.49003 Boehringer Ingelheim Investigational Site
      • Mainz, Germany
        • 1241.30.49007 Boehringer Ingelheim Investigational Site
  • Spain
      • Barcelona, Spain
        • 1241.30.34002 Boehringer Ingelheim Investigational Site
      • Barcelona, Spain
        • 1241.30.34005 Boehringer Ingelheim Investigational Site
      • Madrid, Spain
        • 1241.30.34003 Boehringer Ingelheim Investigational Site
      • Majadahonda (Madrid), Spain
        • 1241.30.34001 Boehringer Ingelheim Investigational Site
  • United Kingdom
      • London, United Kingdom
        • 1241.30.44002 Boehringer Ingelheim Investigational Site
  • United States
    • California
      • La Mesa, California, United States
        • 1241.30.10003 Boehringer Ingelheim Investigational Site
      • San Diego, California, United States
        • 1241.30.10007 Boehringer Ingelheim Investigational Site
    • Florida
      • Deland, Florida, United States
        • 1241.30.10001 Boehringer Ingelheim Investigational Site
      • West Palm Beach, Florida, United States
        • 1241.30.10012 Boehringer Ingelheim Investigational Site
    • Texas
      • Arlington, Texas, United States
        • 1241.30.10011 Boehringer Ingelheim Investigational Site
    • Virginia
      • Norfolk, Virginia, United States
        • 1241.30.10002 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cohort A CPA
Cohort A CPA BI 207127/QD Faldaprevir Ribavirin
Drug: Ribavirin
24 Weeks
Drug: Faldaprevir
24 Weeks
Drug: BI 207127 low dose
24 Weeks
Experimental: cohort A CPB
Cohort B CPB BI 207127/QD Faldaprevir Ribavirin
Drug: Ribavirin
24 Weeks
Drug: Faldaprevir
24 Weeks
Drug: BI 207127 high dose
24 Weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SVR12: Plasma HCV RNA Level Less Than 25 IU/mL at 12 Weeks After End of Treatment (EOT)
Time Frame: 12 weeks after End of Treatment
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.
12 weeks after End of Treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SVR4: Plasma HCV RNA Level Less Than 25 IU/mL at 4 Weeks After End of Treatment (EOT)
Time Frame: 4 weeks after End of Treatment
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.
4 weeks after End of Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

March 22, 2013

First Submitted That Met QC Criteria

April 11, 2013

First Posted (Estimate)

April 12, 2013

Study Record Updates

Last Update Posted (Estimate)

November 20, 2015

Last Update Submitted That Met QC Criteria

October 20, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1241.30
  • 2012-003534-17 (EudraCT Number: EudraCT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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