Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)

Completed · Phase 2

Conditions studied: Hepatitis C

In brief

To compare the antiviral efficacy and safety of a 12-week with a 24-week treatment of BI 201335 at a dose of 120 mg once daily, with a 24-week background of pegylated interferon-alpha 2a (PegIFN) plus ribavirin (RBV), in treatment-naïve patients infected with hepatitis C virus (HCV) genotype 1

Key facts

Study ID: NCT00984620
Run by: Boehringer Ingelheim
People needed: 160
Starts: 2009-09-01
Last updated by the study team: 2015-09-07

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Chronic hepatitis C infection of genotype 1
Therapy-naïve to interferon, pegylated interferon, and ribavirin
HCV viral load > 100.000 IU/ml at screening
Liver biopsy or fibroscan within two years prior to screening that provides evidence of any degree of fibrosis or cirrhosis
Normal retinal finding on fundoscopy within 6 months prior to Day 1
Age 18 to 70 years

You may not qualify if…

HCV of mixed genotype (1/2, 1/3, and 1/4) .
Patients who have been previously treated with at least one dose of any protease inhibitor
Evidence of liver disease due to causes other than chronic HCV infection
Positive for HIV-1 or HIV-2 antibodies
Hepatitis B virus (HBV) infection
Decompensated liver disease, or history of decompensated liver disease
Active malignancy or history of malignancy within the last 5 years
History of alcohol or drug abuse (except cannabis) within the past 12 months.
Body Mass Index < 18 or > 35 kg/m2.
Usage of any investigational drugs within 30 days prior to enrolment
Alpha fetoprotein value >100ng/mL at screening;
Total bilirubin > 1.5 x ULN with ratio of direct/indirect > 1.
ALT or AST level > 10 x ULN

Where it is running

1220.40.002 Boehringer Ingelheim Investigational Site — Tulepo, Mississippi, United States
1220.40.007 Boehringer Ingelheim Investigational Site — New York, New York, United States
1220.40.006 Boehringer Ingelheim Investigational Site — Germantown, Tennessee, United States
1220.40.004 Boehringer Ingelheim Investigational Site — Jackson, Tennessee, United States
1220.40.003 Boehringer Ingelheim Investigational Site — Nashville, Tennessee, United States
1220.40.005 Boehringer Ingelheim Investigational Site — Austin, Texas, United States
1220.40.4303 Boehringer Ingelheim Investigational Site — Linz, Austria
1220.40.4301 Boehringer Ingelheim Investigational Site — Vienna, Austria
1220.40.1004 Boehringer Ingelheim Investigational Site — Calgary, Alberta, Canada
1220.40.1001 Boehringer Ingelheim Investigational Site — Vancouver, British Columbia, Canada
1220.40.1002 Boehringer Ingelheim Investigational Site — Ottawa, Ontario, Canada
1220.40.1003 Boehringer Ingelheim Investigational Site — Montreal, Quebec, Canada
1220.40.1005 Boehringer Ingelheim Investigational Site — Montreal, Quebec, Canada
1220.40.3303A Boehringer Ingelheim Investigational Site — Clichy, France
1220.40.3305A Boehringer Ingelheim Investigational Site — Lille, France
1220.40.3301A Boehringer Ingelheim Investigational Site — Marseille, France
1220.40.3306A Boehringer Ingelheim Investigational Site — Montpellier, France
1220.40.3302A Boehringer Ingelheim Investigational Site — Paris, France
1220.40.3304A Boehringer Ingelheim Investigational Site — Rennes, France
1220.40.4902 Boehringer Ingelheim Investigational Site — Berlin, Germany
1220.40.4909 Boehringer Ingelheim Investigational Site — Berlin, Germany
1220.40.4906 Boehringer Ingelheim Investigational Site — Düsseldorf, Germany
1220.40.4908 Boehringer Ingelheim Investigational Site — Düsseldorf, Germany
1220.40.4904 Boehringer Ingelheim Investigational Site — Hamburg, Germany
1220.40.4905 Boehringer Ingelheim Investigational Site — Mainz, Germany

Full record on ClinicalTrials.gov

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