on Responder- STUDY: MULTICENTER STUDY TO EVALUATE THE EFFICACY OF SILYMARIN IN ADDITION TO COMBINATION-THERAPY WITH PEGYLATED INTERFERON ALFA 2A (PEG-IFN ALFA 2A) AND RIBAVIRIN IN PATIENTS WITH CHRONIC HEPATITIS C - Non Responder Study

Phase 1

• Conditions: HCV-patients, who have not responded to a previous therapy with INF or PEG-INF +/- Ribavirin.

• Registration Number: EUCTR2005-000127-42-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-27
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

•Male and female patients with chronic hepatitis C
•Age between 18 and 65 years
•Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
•Present with at least one elevated serum alanine-aminotransferase (ALT) level higher than normal in the last 6 months before therapy start
?Positive HCV-RNA level in serum (determined with quantitative PCR (COBAS AMPLICOR? MONITOR HCV test v 2.0)
?prior therapy with either interferon or pegylated interferon alone or in combination with ribavirin for at least 12 weeks
?Laboratory parameters (within 35 days prior to study start):

- Hemoglobin values > 12 g/dl in women or > 13 g/dl in men
- Leukocyte count (WBC) > 3 000 /µl
- Platelets count > 100 000/µl
- Creatinine not 1.5 times higher than normal
- normal TSH
- normal uric acid with a maximum tolerance of 15 % in patients without history of
gout ( or uric acid within this range achieved by treatment before study start

•Laboratory parameters (within 3 months prior to study start):
- Hepatitis A anti – IgM negativity
- HIV-Ab negativity
- HbsAg negativity

•Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
•All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end
•Written informed consent obtained
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Class B or C cirrhosis as coded by Child Pugh classification (Appendix A)
•Women with ongoing pregnancy or breast feeding
•Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug
•Any investigational drug 6 weeks prior to the first dose of study drug
•Drug addiction (including alcohol dependence) within 1 year prior to study start.
•Diabetes mellitus in patients receiving an insulin therapy
•History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
•History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
•History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization (for other reason than drug abuse) for psychiatric disease, or a period of disability due to a psychiatric disease. Exception: if there is a current psychiatric report which certifies there is no contraindication to interferon therapy, patient may be included
•History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis etc.)
•History or other evidence of chronic pulmonary disease associated with functional limitation
•History of a severe seizure disorder or current anticonvulsant use
•History of severe cardiac disease and severe coronary heart disease within the last 6 months (angina pectoris, congestive heart failure, recent myocardial infarction, severe hypertension or sygnificant arrythmia). If there is clinical suspicion of coronary heart disease cardiologic workup of the patient prior to study entry is recommended.
•History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
•History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
•History of major organ transplantation with an existing functional graft
•Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
•Inability or unwillingness to provide informed consent or abide by the requirements of the study
Additional exclusion criteria concerning ribavirin:
•Male partners of women who are pregnant
•Any patient with an increased baseline risk for anemia (e.g. thalassemia, spherocytosis, history of GI bleeding, etc) or for whom anemia would be medically problematic
•Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL would not be well-tolerated

Study & Design

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