A Phase 1b, Single Center, Clinical Study to Investigate the Safety and Biological Responses to Baminercept in Patients With Chronic HCV Hepatitis.

Erstes Safety Trial mit Baminercept in chronischen HCV Patienten. Untersuchung des potentiell antiviralen, antiinflammatorischen Effekts sowie Modulation der hepatischen Gen-Expression.

10 Patienten, open label, 10 Wochen Therapie. Sequentielles Enrollement der ersten 4 Patienten.

• Trial with medicinal product

Inclusion criteria: Informed consent Age 18-60 years Chronic HCV infection Non responder (to Peg-IFN alpha2/Ribavirin containing therapy) Elevated ALT Liver biopsy at screening without sings of (pre-)cirrhosis Compensated liver function Absolute neutrophil count > 1500 / mm3 at screening Hemoglobin > 10 g/dL at screening Calculated creatinine clearance of > 60 cc/min at screening Normal TSH at screening

Exclusion criteria: HBV infection Evidence for concomitant liver disease other than HCV hepatitis Evidence for a HCC Alpha-fetoprotein >20ng/ml Autoimmune Disease ANA > 1/320, documented in the last 6 months HIV 1/2 infection ALT and AST >3x ULN, alkaline phosphatase >2,5x ULN Known hypersensitivity or allergy to Baminercept Other clinically significant concomitant disease states Known or suspected non-compliance to study protocol, drug or alcohol abuse Infections other than HCV hepatitis Clinically important chest x-ray abnormality at screening Body mass index (BMI) > 30kg/m2 Concomitant systemic immunosuppressive/-modulating therapy Treatment with anticoagulants Receipt of live vaccine within 4 weeks prior to study start Symptomatic hypogammaglobulinemia with history of recurrent infections Subjects with a history of malignant disease Treatment with other investigational products or participation in an interventional clinical trial within the last 3 months Pregnancy or Breastfeeding Inability or refusal to practice a safe contraception