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

Chronic HCV Hepatitis C Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01164384
• Other study ID #: BamiHepC-Study
• Status: Not yet recruiting
• Phase: Phase 1
• First received: July 8, 2010
• Last updated: July 15, 2010
• Start date: October 2010
• Est. completion date: February 2013

Study information

• Verified date: July 2010
• Source: University of Zurich
• Contact: 01 Studienregister MasterAdmins
• Phone: +41 (0)44 255 11 11
• Is FDA regulated: No
• Health authority: Switzerland: UZurich
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 0
• Est. completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic HCV Hepatitis C
• Hepatitis

Intervention

Drug:
• Baminercept

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	PD Dr. rer. nat. Mathias Heikenwälder

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sicherheit