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 - BI207127 in combination with faldaprevir and ribavirin in treatment naive HCV GT1 infected patients

Boehringer Ingelheim Pharma GmbH & Co. KG0 sites490 target enrollmentSeptember 17, 2012

DrugsCopegus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG
Enrollment: 490
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 17, 2012

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Boehringer Ingelheim Pharma GmbH & Co. KG

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 GT1b confirmed by genotypic testing at screening
•3\. HCV viral load \= 1,000 IU/mL at screening.
•4\. Patients who have never been previously treated with interferon alone, interferon\+RBV, PegIFN\+RBV or PegIFN\+RBV\+an investigational/approved DAA or any other HCV treatment regimen.
•5\. Availability of a liver biopsy within 3 years or fibroscan within 6 months prior to randomisation. Note: patients who do not have a liver biopsy (nor fibroscan) due to contraindication of the procedure should not be excluded for this reason and will be assigned to 24\-week therapy. The decision on the inclusion of these patients should be discussed with the CML. Patients with a liver biopsy performed 3 or more years prior to screening demonstrating cirrhosis do not need to repeat a liver biopsy or fibroscan.
•6\. Age 18 to 75 years (inclusive).
•7\. Female patients with a negative urine pregnancy test (dipstick) at Visit 2 prior to randomization:

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, mixed GT1a/1b, or undefined GT1\.
•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.
•6\. Confirmed or suspected active malignancy or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix).
•7\. History of illicit drug abuse other than cannabis or chronic alcohol abuse within 12 months prior to randomisation.
•8\. Subject is not willing to comply with the precautionary measures to prevent photosensitivity (avoid excessive sun exposure and use sun block on a daily basis).
•9\. A condition that is insufficiently diagnosed, treated or clinically unstable which in the opinion of investigator may put the patient at risk because of participation in this study, influence the results of this study, or limit the patient’s ability to participate in this study, including but not limited to severe chronic obstructive pulmonary disease, uncontrolled psychiatric disease.
•10\. Decompensated liver disease, or history of decompensated liver disease, as evidenced by ascites, hepatic encephalopathy, history of esophageal variceal bleeding, or any other evidence of previous decompensation.