EUCTR2012-003534-17-DEActive, not recruitingNot Applicable
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
Boehringer Ingelheim Pharma GmbH & Co. KG0 sites35 target enrollmentStarted: January 18, 2013Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 35
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Treatment-naïve patients, or treatment-experienced to an approved PegIFN/RBV regimen (prior relapse, interferon intolerant, and prior partial response), or treatment-experienced to IFN not as part of an approved PegIFN/RBV regimen.
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 29
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
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.
- •Previous treatment with an investigational or approved direct acting antiviral drug (DAA).
- •Patients classified as Child Pugh C (score 10-15 points).
Investigators
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