BI 207127 / Faldaprevir Combination Therapy in Hepatic Impairment (Child-Pugh B) Patients With Genotype 1b Chronic Hepatitis C Infection: HCVerso3
NCT ID: NCT01830127
Last Updated: 2015-11-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2013-04-30
2014-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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cohort A CPA
Cohort A CPA BI 207127/QD Faldaprevir Ribavirin
Ribavirin
24 Weeks
Faldaprevir
24 Weeks
BI 207127 low dose
24 Weeks
cohort A CPB
Cohort B CPB BI 207127/QD Faldaprevir Ribavirin
BI 207127 high dose
24 Weeks
Ribavirin
24 Weeks
Faldaprevir
24 Weeks
Interventions
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Ribavirin
24 Weeks
BI 207127 high dose
24 Weeks
Faldaprevir
24 Weeks
Ribavirin
24 Weeks
BI 207127 low dose
24 Weeks
Faldaprevir
24 Weeks
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1241.30.10003 Boehringer Ingelheim Investigational Site
La Mesa, California, United States
1241.30.10007 Boehringer Ingelheim Investigational Site
San Diego, California, United States
1241.30.10001 Boehringer Ingelheim Investigational Site
DeLand, Florida, United States
1241.30.10012 Boehringer Ingelheim Investigational Site
West Palm Beach, Florida, United States
1241.30.10011 Boehringer Ingelheim Investigational Site
Arlington, Texas, United States
1241.30.10002 Boehringer Ingelheim Investigational Site
Norfolk, Virginia, United States
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
Hanover, , Germany
1241.30.49003 Boehringer Ingelheim Investigational Site
Leipzig, , Germany
1241.30.49007 Boehringer Ingelheim Investigational Site
Mainz, , Germany
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
1241.30.44002 Boehringer Ingelheim Investigational Site
London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2012-003534-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1241.30
Identifier Type: -
Identifier Source: org_study_id