Status:
COMPLETED
Characterization of Clonal B Cell Populations in HCV Infection
Lead Sponsor:
Rockefeller University
Collaborating Sponsors:
New York Presbyterian Hospital
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to investigate the mechanism of autoantibody production during chronic hepatitis C virus (HCV) infection. 10-50% of individuals with HCV have symptoms of mixed cryoglobuli...
Detailed Description
Hepatitis C virus (HCV) infects approximately 170 million people worldwide. About 10-50% of persons with HCV have MC. MC is associated with the development of autoimmune symptoms and B cell proliferat...
Eligibility Criteria
Inclusion
- At least 18 years of age.
- Ability to give informed consent.
- WBC greater than 3,000/mm3.
- Platelets greater than 80,000/mm3.
- Hb at least 9.5 g/dl.
- INR less than 1.5.
- Biologic therapy: Greater than 6 months post-Rituximab therapy.
- Greater than 6 months post IFN- alpha and Ribavirin therapy.
Exclusion
- Decompensated cirrhosis.
- Serious uncontrolled medical illness.
- Receipt of immune modulators or suppressors within 30 days prior to study entry, including, but not limited to, interferons and thalidomide.
- Psychiatric illness or social condition that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Alcohol or drug use or dependence that, in the opinion of the investigator,would interfere with adherence to study requirements.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00435201
Start Date
January 1 2007
End Date
June 1 2013
Last Update
August 9 2013
Active Locations (2)
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1
Rockefeller University Hospital
New York, New York, United States, 10065
2
Oxford University
Oxford, United Kingdom