Antiviral effect and safety of once daily BI 201335 NA in hepatitis C virus genotype 1 infected treatment-naïve patients for 12 or 24 weeks as combination therapy with pegylated interferon-a 2a and ribavirin (open label, randomised, Phase II)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 140

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

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 < 18 or > 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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