High-Dose Ribavirin in Combination With Standard Dose Peginterferon for Treatment of Chronic Hepatitis C Patients Who Are Nonresponders to Previous Standard Dosed Peginterferon/Ribavirin Combination Therapy

• Conditions: Chronic hepatitis C

• Registration Number: EUCTR2006-003396-13-SE
• Lead Sponsor: Karolinska University Hospital, Huddinge

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Male and female patients =18 years of age
•Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
•Genotype 1
•Non-response to a previous therapy with peginterferon alfa-2a/ribavirin combination therapy given for at least 12 weeks (defined as positive HCV-RNA test result at every assessment after initiation of PEG-IFN alfa-2a combination therapy, with at least one HCV-RNA test performed on treatment after at least 12 weeks therapy).
•Detectable serum HCV-RNA
•Elevated serum ALT levels
•Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection (histological cirrhosis = fibrosis grade IV are excluded)
•Compensated liver disease (Child-Pugh Grade A clinical classification)
•Negative urine pregnancy test (for women of childbearing potential)
•All fertile males and females must be using effective contraception during treatment and during the 6 months after treatment end

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

•Women with ongoing pregnancy or breast feeding
•Liver biopsy findings consistent with histological cirrhosis (fibrosis grade IV) or clinical evidence of cirrhosis
•Therapy with any systemic anti-neoplastic or immune modulatory treatment
•Any investigational drug (other than study drugs) =6 weeks prior to the first dose of study drug,
•Co-infection with hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV)
•Significant chronic liver disease other than HCV
•Hepatocellular carcinoma
•Decompensated liver disease
•Neutrophil count <1.5 x 10 (9) /L or platelet count <90 x 10 (9) /L at screening
•Creatinine clearance < 50 ml/min at screening
•Severe psychiatric disease, especially depression.
•Seizure disorders
•Other severe chronic illnesses that could constitute a medical risk
•Thyroid disease poorly controlled on prescribed medications
•Drug abuse (including excessive alcohol consumption) within one year of study entry
•Hgb <120 g/L in women or <130 g/L in men at screening
•Any patient with an increased baseline risk for anemia or for whom anemia would be medically problematic
•Patients with coronary artery disease or cerebrovascular disease should not be enrolled if an acute decrease in hemoglobin by up to 40 g/L would not be well-tolerated
•Uncontrolled hypertension
•Adverse reaction to erythropoietin or other components of NeoRecormon®
•History or evidence of risk of thrombosis
•Thrombocytosis, platelets >500 000/mm3

Study & Design

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