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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Zurich.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
PD Dr. rer. nat. Mathias Heikenwälder
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01164384
First received: July 8, 2010
Last updated: July 15, 2010
Last verified: July 2010

July 8, 2010
July 15, 2010
October 2010
Not Provided
Sicherheit
Same as current
Complete list of historical versions of study NCT01164384 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Phase 1b, Single Center, Clinical Study to Investigate the Safety and Biological Responses to Baminercept in Patients With Chronic HCV Hepatitis.
Not Provided

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
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic HCV Hepatitis C
Drug: Baminercept
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
Not Provided
February 2013
Not Provided

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

Both
18 Years to 60 Years
Yes
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11
Switzerland
 
NCT01164384
BamiHepC-Study
Not Provided
Not Provided
University of Zurich
PD Dr. rer. nat. Mathias Heikenwälder
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
University of Zurich
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP