Status:
UNKNOWN
A Phase 1b, Single Center, Clinical Study to Investigate the Safety and Biological Responses to Baminercept in Patients With Chronic HCV Hepatitis.
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
PD Dr. rer. nat. Mathias Heikenwälder
Conditions:
Chronic HCV Hepatitis C
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Erstes Safety Trial mit Baminercept in chronischen HCV Patienten. Untersuchung des potentiell antiviralen, antiinflammatorischen Effekts sowie Modulation der hepatischen Gen-Expression. 10 Patienten,...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
End Date :
February 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01164384
Start Date
October 1 2010
End Date
February 1 2013
Last Update
July 16 2010
Active Locations (1)
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1
Zurich, Switzerland