Status:
COMPLETED
Short Term Treatment With BI 201335, Peginterferon-alpha 2a and Ribavirin in Hepatitis c Virus Genotype-1 Treatment-naïve Patients (SILEN-C3)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00984620
Start Date
September 1 2009
Last Update
September 7 2015
Active Locations (28)
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1
1220.40.002 Boehringer Ingelheim Investigational Site
Tulepo, Mississippi, United States
2
1220.40.007 Boehringer Ingelheim Investigational Site
New York, New York, United States
3
1220.40.006 Boehringer Ingelheim Investigational Site
Germantown, Tennessee, United States
4
1220.40.004 Boehringer Ingelheim Investigational Site
Jackson, Tennessee, United States