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