Status:
COMPLETED
Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI 201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus (HCV) genotype 1 in...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- chronic HCV GT1; therapy-naive to IFN, PegIFN, or RBV; HCV VL \>=100,000 IU/mL Liver biopsy within 2 years prior to study enrolment showing necroinflammatory activity or presence of fibrosis Normal retinal finding on fundoscopy within 6 months prior to Day 1 age 18-65 years Females and males with adequate contraception
- Exclusion criteria:
- Mixed genotype (1/2, 1/3, or 1/4), diagnosed by genotypic testing at screening Previous treatment with protease inhibitor Evidence of liver disease due to causes other than chronic HCV infection HIV-1 or HIV-2 positive HBV positive Decompensated liver disease, or history of decompensated liver disease Active or suspected malignancy or history of malignancy within the last 5 years History of alcohol or drug abuse within the past 12 months. Usage of any investigational drug within 30 days prior to enrolment, or 5 half-lives, whichever is longer Known hypersensitivity to any ingredient of the study drugs Condition that is defined as one which in the opinion of the investigator may put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study Alpha-fetoprotein value \> 100ng/mL at screening; if \>20ng/mL and \<=100ng/mL, patients can be included if there is no evidence of liver cancer in two congruent imaging studies Total bilirubin \> 1.5x ULN wiht ratio of direct/indirect \>1. ALT or AST levels \> 5x ULN INR prolonged to \>1.5x ULN Exclusion criteria related to PegIFN and/or RBV restrictions.
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
719 Patients enrolled
Trial Details
Trial ID
NCT00774397
Start Date
October 1 2008
Last Update
November 16 2015
Active Locations (100)
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1
1220.5.0001 Boehringer Ingelheim Investigational Site
San Francisco, California, United States
2
1220.5.0008 Boehringer Ingelheim Investigational Site
San Francisco, California, United States
3
1220.5.0005 Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
4
1220.5.0006 Boehringer Ingelheim Investigational Site
Lutherville, Maryland, United States