chronic hepatitis C MedDRA version: 9.1 Level: LLT Classification code 10002724 Term: Anti-HCV positive MedDRA version: 9.1 Level: LLT Classification code 10019183 Term: HCV MedDRA version: 9.1 Level: LLT Classification code 10019752 Term: Hepatitis C virus (HCV)
Conditions
Interventions
Product Name: BI 201335 NA / 120 mg / soft capsule
Pharmaceutical Form: Capsule, soft
Current Sponsor code: BI 201335
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Chronic hepatitis C infection of genotype 1 (1a, 1b or mixed 1a/1b) confirmed by genotypic testing at screening 2) Therapy-naïve to interferon, pegylated interferon, and ribavirin 3) HCV viral load = 100.000 IU/ml at screening 4) Liver biopsy or fibroscan within two years prior to screening that provides evidence of any degree of fibrosis or cirrhosis 5) Normal retinal finding on fundoscopy within 6 months prior to Day 1 6) Age 18 to 70 years 7) Female patients who are infertile or who are of childbearing potential with a negative pregnancy test and agreeing to abstain from intercourse or to use one accepted method of birth control in addition to the use of a condom or Male patients who are sterile, or who agree to abstain from intercourse or who use a condom while their female partners use one medically accepted method of birth control 8) Signed informed consent form prior to trial participation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Hepatitis C infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening. 2) Patients who have been previously treated with at least one dose of any protease inhibitor for acute or chronic hepatitis C infection 3) Evidence of liver disease due to causes other than chronic HCV infection 4) Positive for HIV-1 or HIV-2 antibodies 5) Hepatitis B virus (HBV) infection based on presence of HBs-Ag 6) Decompensated liver disease, or history of decompensated liver disease 7) Active or suspected malignancy or history of malignancy within the last 5 years 8) History of alcohol or drug abuse (except cannabis) within the past 12 months. 9) Body Mass Index 35 m2/kg. 10) Usage of any investigational drugs within 30 days prior to enrolment 11) Alpha fetoprotein value >100ng/mL at screening; if > 20ng/mL and = 100ng/mL, if liver cancer is excluded 12) Total bilirubin > 1.5 x ULN with ratio of direct/indirect > 1. 13) ALT or AST level > 10 x ULN 14) TSH and T4 outside normal limits and not adequately controlled thyroid function; 15) Poorly controlled diabetes mellitus as evidenced by HbA1c > 7.5% 16) History of moderate, severe or uncontrolled psychiatric disease, especially depression, including a history of hospitalisation or prior suicidal attempt; 17) Active autoimmune disease, including autoimmune hepatitis 18) Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to enrolment 19) Received silymarin (milk thistle) or glycyrrhizin or Sho-saiko-to (SST) within 30 days prior to enrolment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the antiviral effect of 12 weeks versus 24 weeks of treatment with 120 mg of BI 201335 NA soft gelatin capsules given once daily in combination with 24 or 48 weeks of pegylated interferon-a 2a and ribavirin (PegIFN/RBV) in HCV genotype 1 infected treatment-naïve patients. ;Secondary Objective: To compare the safety of 12 weeks versus 24 weeks of treatment with 120 mg of BI 201335 NA soft gelatin capsules given once daily in combination with 24 or 48 weeks of pegylated interferon-a 2a and ribavirin (PegIFN/RBV) in HCV genotype 1 infected treatment-naïve patients. ;Primary end point(s): Virological response at week 28 (W28VR): - i.e. virological response sustained for 4 weeks after end of all treatment for patients with viral load BLQ at week 4 and below lower limit of detection (BLD) at weeks 8-12 - i.e. virological response 4 weeks after end of treatment with BI 201335 NA, but on continued treatment with PegIFN/RBV for patients not achieving a VL BLQ at week 4 and a VL BLD at weeks 8-12 | — |
Countries
Austria, France, Germany
Outcome results
None listed