EUCTR2012-003535-27-IT
Active, not recruiting
Not Applicable
A phase III randomised, partially double-blind and placebo-controlled study of BI 207127 in combination with faldaprevir and ribavirin for chronic genotype 1 hepatitis C infection in an extended population of treatment naïve patients that includes those ineligible to receive peginterferon
BOEHRINGER ING.0 sites835 target enrollmentOctober 19, 2012
DrugsCopegus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- BOEHRINGER ING.
- Enrollment
- 835
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Chronic hepatitis C infection, diagnosed by positive anti\-HCV
- •antibodies and detected HCV RNA at screening in addition to at least one
- •of the following:
- •a. positive anti\-HCV antibodies or detected HCV RNA at least 6 months
- •prior to screening, or
- •b. liver biopsy indicating chronic HCV infection, or
- •c. history of elevated alanine aminotransferase (ALT) levels at least 6
- •months prior to screening.
- •2\. HCV infection of:
- •a. sub\-GT1b confirmed by genotypic testing at screening; or,
Exclusion Criteria
- •1\. HCV infection of mixed GT (1/2, 1/3, and 1/4\) diagnosed by genotypic
- •testing at screening.
- •2\. HCV infection of sub\-GT1a in patients with IL\-28b CT or TT (non\-CC
- •polymorphisms).
- •3\. 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. Note: patients with steatosis as part of the
- •histological findings of the liver biopsy are not excluded.
- •4\. HIV infection.
- •5\. Hepatitis B virus (HBV) infection based on presence of HBs\-Ag.
Outcomes
Primary Outcomes
Not specified
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