• Conditions: Hepatitis C; MedDRA version: 14.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-000141-20-ES
• Lead Sponsor: Boehringer Ingelheim España, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-30
• Last Update Posted: 30 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

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:
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. Evidence of acute or chronic liver disease due to causes other than chronic HCV
infection.
2. HIV co-infection.
3. Hepatitis B virus (HBV) infection based on presence of HBs-Ag.
4. 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).
5. Active or, history of alcohol or illicit drug abuse other than cannabis within the past 12
months.
6. 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.
7. Usage of any investigational drugs within 30 days prior to screening, or planned usage
of an investigational drug during the course of this study.
8. 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.
9. Received silymarin (milk thistle), glycyrrhizin, or Sho-saiko-to (SST) within 28 days
prior to screening.
10. Patients who have been previously treated with at least one dose of any antiviral or
immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic HCV
infection including and not restricted to protease or polymerase inhibitors.
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 Magnetic Resonance Imaging [MRI] within
last six 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
any laboratory results of any of the following:
-. International normalized ratio (INR) of = 1.7.
-. Serum Albumin = 3.5 g/dL.
-. Serum total bilirubin = 2.0 mg/dL (except when the increase is predominately due to
unconjugated bilirubin 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 five years.
15. Clinical evidence of significant or unstable cardiovascular disease, including angina,
myocardial infarction within six 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 retin

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified