Clinical Trial: Safety, Antiviral Effect and PK of BI 207127 + BI 201335 +/- RBV for 4 up to 40 Weeks in Patients With Chronic HCV Genotype 1 Infection

Study Start Date: May 2010

Estimated Completion Date: March 2016

Interventions

• Drug: RBV
• Drug: Ribavirin
• Drug: BI 207127
• Drug: BI 201335
• Drug: BI 207217

Inclusion criteria

• Chronic hepatitis C virus (HCV) infection of genotype (GT) 1
• Parts 1-3:Treatment naive to Interferon -alfa (IFN), Pegylated interferon -alfa (PegIFN), ribavirin (RBV), and any direct acting antiviral agent for chronic hepatitis C
• Part 4: Treatment experienced with confirmed prior virological failure to an approved dose of PegIFN/RBV (null-response)
• HCV RNA >=10,000 IU/mL at screening
• Liver biopsy within two years or fibroscan within six months prior to baseline
• Liver biopsy within two years or fibroscan within 6 months prior to screening
• Age 18-75 years

Exclusion criteria

• Hepatitis C virus (HCV) infection of mixed genotype
• Evidence of liver disease due to causes other than chronic HCV infection
• Positive ELISA for human immunodeficiency virus (HIV)
• Hepatitis B virus (HBV) infection
• Decompensated liver disease or history of decompensated liver disease
• Active or suspected malignancy within the last 5 years
• Ongoing or historical photosensitivity or recurrent rash
• History of alcohol or drug abuse (except cannabis) within the past 12 months
• Body mass index (BMI)I <18 or > 35 kg/m2
• Usage of any investigational drugs within 30 days prior to enrolment, or 5 half-lives, whichever is longer; o the planned usage of an investigational drug during the course of the current study
• Known hypersensitivity to any ingredient of the study drugs
• A condition that is defined as one which in the opinion of the investigator may interfere with the patient's capability for participation in the trial or may influence the results of the trial
• Alpha fetoprotein >100ng/mL at screening; if >20ng/mL and <=100ng/mL, patients can be included if there is no evidence of liver cancer in an appropriate imaging study within 6 months prior to randomisation
• Total bilirubin > 2 mg/dL with ratio of direct/indirect > 1
• AST or ALT >5xULN
• INR prolonged to >1.7xULN
• Requirement for chronic systemic corticosteroids
• Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to enrolment or 5 half-lives, whichever is longer
• Received silymarin or glycyrrhizin or Sho-saiko-to within 30 days prior to enrolment
• Contraindications pertaining to PegIFN or RBV

Study Locations And Contact Information

• 1241.21.40002 Boehringer Ingelheim Investigational Site, Bucharest
• 1241.21.49001 Boehringer Ingelheim Investigational Site, Frankfurt am Main
• 1241.21.49008 Boehringer Ingelheim Investigational Site, Mainz
• 1241.21.34005 Boehringer Ingelheim Investigational Site, Barcelona
• 1241.21.43001 Boehringer Ingelheim Investigational Site, Wien
• 1241.21.0008 Boehringer Ingelheim Investigational Site, Springfield Massachusetts
• 1241.21.0012 Boehringer Ingelheim Investigational Site, Arlington Texas
• 1241.21.35104 Boehringer Ingelheim Investigational Site, Coimbra
• 1241.21.0004 Boehringer Ingelheim Investigational Site, San Francisco California
• 1241.21.0010 Boehringer Ingelheim Investigational Site, Houston Texas
• 1241.21.0011 Boehringer Ingelheim Investigational Site, Palm Harbor Florida
• 1241.21.49005 Boehringer Ingelheim Investigational Site, Esslingen
• 1241.21.33007 Boehringer Ingelheim Investigational Site, Grenoble cédex 9
• 1241.21.40003 Boehringer Ingelheim Investigational Site, Bucharest
• 1241.21.35105 Boehringer Ingelheim Investigational Site, Lisboa
• 1241.21.61002 Boehringer Ingelheim Investigational Site, Heidelberg Victoria
• 1241.21.33005 Boehringer Ingelheim Investigational Site, Clichy
• 1241.21.0014 Boehringer Ingelheim Investigational Site, Oceanside California
• 1241.21.64001 Boehringer Ingelheim Investigational Site, Auckland NZ
• 1241.21.0017 Boehringer Ingelheim Investigational Site, Seattle Washington
• 1241.21.49002 Boehringer Ingelheim Investigational Site, Berlin
• 1241.21.43002 Boehringer Ingelheim Investigational Site, Wien
• 1241.21.33002 Boehringer Ingelheim Investigational Site, Montpellier
• 1241.21.33001 Boehringer Ingelheim Investigational Site, Marseille
• 1241.21.35101 Boehringer Ingelheim Investigational Site, Lisboa
• 1241.21.33008 Boehringer Ingelheim Investigational Site, Paris
• 1241.21.43003 Boehringer Ingelheim Investigational Site, Linz
• 1241.21.0005 Boehringer Ingelheim Investigational Site, Austin Texas
• 1241.21.49006 Boehringer Ingelheim Investigational Site, Hamburg
• 1241.21.33006 Boehringer Ingelheim Investigational Site, Vandoeuvre Cedex
• 1241.21.34001 Boehringer Ingelheim Investigational Site, Majadahonda-Madrid
• 1241.21.0006 Boehringer Ingelheim Investigational Site, San Diego California
• 1241.21.0015 Boehringer Ingelheim Investigational Site, Portland Oregon
• 1241.21.34003 Boehringer Ingelheim Investigational Site, Madrid
• 1241.21.0016 Boehringer Ingelheim Investigational Site, Richmond Virginia
• 1241.21.35102 Boehringer Ingelheim Investigational Site, Porto
• 1241.21.0003 Boehringer Ingelheim Investigational Site, La Jolla California
• 1241.21.34004 Boehringer Ingelheim Investigational Site, Madrid
• 1241.21.0018 Boehringer Ingelheim Investigational Site, San Diego California
• 1241.21.49004 Boehringer Ingelheim Investigational Site, Leipzig
• 1241.21.0013 Boehringer Ingelheim Investigational Site, Valparaiso Indiana
• 1241.21.41006 Boehringer Ingelheim Investigational Site, Bern
• 1241.21.41003 Boehringer Ingelheim Investigational Site, Basel
• 1241.21.0019 Boehringer Ingelheim Investigational Site, Fayetteville North Carolina
• 1241.21.34006 Boehringer Ingelheim Investigational Site, Valencia
• 1241.21.41001 Boehringer Ingelheim Investigational Site, St. Gallen
• 1241.21.34002 Boehringer Ingelheim Investigational Site, Barcelona
• 1241.21.0007 Boehringer Ingelheim Investigational Site, Dallas Texas
• 1241.21.35103 Boehringer Ingelheim Investigational Site, Aveiro
• 1241.21.40001 Boehringer Ingelheim Investigational Site, Bucharest
• 1241.21.49007 Boehringer Ingelheim Investigational Site, Düsseldorf
• 1241.21.33003 Boehringer Ingelheim Investigational Site, Lyon
• 1241.21.49009 Boehringer Ingelheim Investigational Site, Hannover
• 1241.21.33004 Boehringer Ingelheim Investigational Site, Paris
• 1241.21.41002 Boehringer Ingelheim Investigational Site, Zürich
• 1241.21.49003 Boehringer Ingelheim Investigational Site, Berlin
• 1241.21.61001 Boehringer Ingelheim Investigational Site, Melbourne Victoria

Description:

The substances BI 201335 and BI 207127 are being developed for the treatment of chronic hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from replicating. The currently available medications pegylated interferon alfa and ribavirin for hepatitis C ca have considerable adverse events in patients and in many cases are not sufficiently effective. This is particularly the case in treatment of patients infected with genotype 1 of HCV. A combination therapy of these new substances without pegylated interferon alfa may be associated with fewer adverse events that currently available (pegylated interferon-alfa-based) medication and may also provide a treatment option to the large number of patients with contraindications or intolerance to pegylated interferon alfa.

See this on ClinicalTrials.gov

Source