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Trial record 1 of 1 for:    hcverso3
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BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01830127
First Posted: April 12, 2013
Last Update Posted: November 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
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).

Condition Intervention Phase
Hepatitis C, Chronic Drug: Ribavirin Drug: BI 207127 high dose Drug: Faldaprevir Drug: BI 207127 low dose Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 35
Study Start Date: April 2013
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: BI 207127 high dose
24 Weeks
Drug: Ribavirin
24 Weeks
Drug: Faldaprevir
24 Weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830127


Locations
United States, California
1241.30.10003 Boehringer Ingelheim Investigational Site
La Mesa, California, United States
1241.30.10007 Boehringer Ingelheim Investigational Site
San Diego, California, United States
United States, Florida
1241.30.10001 Boehringer Ingelheim Investigational Site
Deland, Florida, United States
1241.30.10012 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida, United States
United States, Texas
1241.30.10011 Boehringer Ingelheim Investigational Site
Arlington, Texas, United States
United States, Virginia
1241.30.10002 Boehringer Ingelheim Investigational Site
Norfolk, Virginia, United States
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
Berlin, Germany
1241.30.49008 Boehringer Ingelheim Investigational Site
Bonn, Germany
1241.30.49006 Boehringer Ingelheim Investigational Site
Frankfurt am Main, Germany
1241.30.49001 Boehringer Ingelheim Investigational Site
Hannover, Germany
1241.30.49003 Boehringer Ingelheim Investigational Site
Leipzig, Germany
1241.30.49007 Boehringer Ingelheim Investigational Site
Mainz, Germany
Spain
1241.30.34002 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1241.30.34005 Boehringer Ingelheim Investigational Site
Barcelona, Spain
1241.30.34003 Boehringer Ingelheim Investigational Site
Madrid, Spain
1241.30.34001 Boehringer Ingelheim Investigational Site
Majadahonda (Madrid), Spain
United Kingdom
1241.30.44002 Boehringer Ingelheim Investigational Site
London, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01830127     History of Changes
Other Study ID Numbers: 1241.30
2012-003534-17 ( EudraCT Number: EudraCT )
First Submitted: March 22, 2013
First Posted: April 12, 2013
Results First Submitted: October 20, 2015
Results First Posted: November 20, 2015
Last Update Posted: November 20, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents