A rollover trial to give Hepatitis C patients who failed on a placebo arm of a previous BI Phase III trial access to BI 201335

Phase 1

Conditions: Hepatitis C
Therapeutic area: Diseases [C] - Virus Diseases [C02]
MedDRA version: 20.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations

Registration Number: EUCTR2011-000141-20-GB

Lead Sponsor: Boehringer Ingelheim Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 121

Inclusion Criteria

1. Patients from trials 1220.7, 1220.30 and 1220.47 of BI 201335 who have failed treatment with PegIFN/RBV in the placebo groups due to protocol-defined criteria of treatment failure (i.e. either non-response on treatment or relapse after end of treatment [EOT]).

2. Patients must have received at least 4 weeks of assigned trial medication and been compliant with all study procedures.

3.Female patients:
a)with documented hysterectomy,
b)who have had both ovaries removed,
c)with documented tubal ligation,
d)who are post-menopausal with last menstrual period at least 12 months prior to screening, or
e)of childbearing potential with a negative serum pregnancy test at screening and Day 1, that, if sexually active, agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of RBV in addition to the consistent and correct use of a condom. Patients must agree not to breast-feed at any time from the date of screening until 7 months after the last dose of RBV.
f)Medically accepted methods of contraception for females in this trial are ethinyl estradiol-containing contraceptives, diaphragm with spermicide substance, intra-uterine device and cervical cap.

Male patients:
a)who are documented to be sterile, or
b)who are without pregnant female partner(s) and consistently and correctly use a condom while their female partner(s) (if of child-bearing potential) agree to use one of the appropriate medically accepted methods of birth control from the date of screening until 7 months after the last dose of ribavirin. It is in the responsibility of the male patient to ensure that his partner(s) is not pregnant prior to screening into the study or becomes pregnant during the treatment and the observation phase. Female partners of childbearing potential must perform monthly pregnancy tests from the date of screening until 7 months after the last dose of ribavirin (tests will be provided by the sponsor).

4.Signed informed consent form prior to trial participation.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening 2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection 3. HIV co-infection 4. Hepatitis B virus (HBV) infection based on presence of HBs-Ag 5. Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix) 6. Active or, history of alcohol or illicit drug abuse other than cannabis within the past 12 months 7. A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patient’s ability to participate in this study 8. Usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study. 9. Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to screening. Patients being treated with oral antivirals such as acyclovir, famiclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened. 10. Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days prior to enrolment and throughout the treatment phase of this trial. 11. Known hypersensitivity to any ingredient of the study drugs. 12. Alpha fetoprotein value > 100 ng/mL at screening; if > 20 ng/mL and = 100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomization (Visit 2). 13. Decompensated liver disease, or history of decompensated liver disease, as defined by the presence of: hepatic encephalopathy, ascites, or esophageal variceal bleeding and/or laboratory results of any of the following: a. International normalized ratio (INR) of = 1.7 b. Serum Albumin = 3.5 g/dL c. Serum total bilirubin = 2.0 mg/dL (except when the increase is predominately due to unconjugated bilirubin and related to Gilbert’s syndrome). 14. Pre-existing psychiatric condition that could interfere with the subject’s participation in and completion of the study including but not limited to prior suicidal attempt, schizophrenia, major depression syndrome, severe anxiety, severe personality disorder, a period of disability or impairment due to a psychiatric disease within the past 5 years. 15. Clinical evidence of significant or unstable cardiovascular disease, including angina, myocardial infarction within 6 months, pulmonary hypertension, cardiomyopathy, congestive heart failure, uncontrolled hypertension, significant arrhythmia or clinically significant abnormalities on ECG at screening. 16. Clinical evidence of chronic pulmonary disease (e.g. chronic obstructive pulmonary disease) associated with functional impairment. 17. Active autoimmune disease, including autoimmune hepatitis. 18. History or evidence of retinopathy or clinically significant ophthalmological disorder including diabetic or hypertensive retinopathy, retinal haemorrhages, cotton wool spots, papilloedema, optic neuropathy, or retinal artery/vein obstruction. An eye examination performed within 6 months prior to randomization (Visit 2) is required. 19. Organ tra

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Offer patients with virological failure in the placebo controls of the Phase III trials 1220.7, 1220.30 and 1220.47 open label treatment with BI 201335, PegIFN and RBV. ;Secondary Objective: To collect additional evidence for the safety of 24 weeks of treatment with BI 201335 240 mg once daily in combination with 48 of PegIFN and RBV in HCV genotype 1 infected treatment-experienced patients.;Primary end point(s): Sustained Virological Response (SVR): Plasma HCV RNA level < 25 IU/mL, undetected 24 weeks after the originally planned treatment duration;Timepoint(s) of evaluation of this end point: 24 weeks after the originally planned treatment duration

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): 1. Virological response after 12 weeks of treatment discontinuation (SVR12): - Plasma HCV RNA level < 25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.<br> <br> 2. Early Treatment Success (ETS): Plasma HCV RNA level <25 IU/mL (detected or undetected) at Week 4 and HCV RNA <25 IU/mL, undetected at Week 8.<br> <br> 3. ALT normalisation: ALT in normal range 24 weeks after end of the originally planned treatment duration.<br> ;<br> Timepoint(s) of evaluation of this end point: 1. 12 weeks after the originally planned treatment duration.<br> <br> 2. Week 4 and week 8 of treatment.<br> <br> 3. 24 weeks after end of the originally planned treatment duration.<br>

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