Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
161 participants
OBSERVATIONAL
2001-09-30
2013-05-31
Brief Summary
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Detailed Description
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1. One hypothesis is that HCV infection results in increased levels of specific cytokines and chemokines that may affect the motility and localization of immature and mature B cells. An alternative model is that HCV infection leads to chronic antigenic stimulation of B lymphocytes, and that the abnormalities of B cell function associated with HCV infection reflect this chronic antigenic stimulation.
2. A second hypothesis is that autoantibodies and immune complexes present in HCV patient serum contribute to the persistence and spread of viral infection.
To test these hypotheses, we are measuring levels of chemokines, the frequency of circulating B cells (mature resting B cells, mature activated B cells, memory B cells, and immature B cells), and the levels and components of ICs in the blood of HCV-infected patients. Controls include healthy volunteers and patients with chronic liver disease unrelated to HCV infection. No interventions in patient care are planned. When patients elect to undergo standard antiviral therapies under the supervision of their hepatologists, we will study the outcomes of therapy (no virologic response, partial or transient virologic response, sustained virologic response) to determine whether any of the observed alterations in chemokine levels, B cell frequency or activation, or immune complex levels correlate with the patient's response to antiviral therapy.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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HCV infection
current HCV infection, including intravenous drug users
No interventions assigned to this group
cryoglobulinemia
cryoglobulinemia and without HCV infection
No interventions assigned to this group
chronic liver disease
chronic liver disease not due to hepatitis C virus infection
No interventions assigned to this group
Sustained Virologic responders
successfully treated for HCV infection
No interventions assigned to this group
normal
normal, healthy volunteers
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Chronic infection with hepatitis C virus
* Other chronic liver disease unrelated to hepatitis C virus
* Subjects in all groups must have sufficiently healthy veins to allow blood collection.
Exclusion Criteria
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
New York Presbyterian Hospital
OTHER
Rockefeller University
OTHER
Responsible Party
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Principal Investigators
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Lynn B Dustin, PHD
Role: PRINCIPAL_INVESTIGATOR
Rockefeller University
Locations
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Rockefeller University Hosital
New York, New York, United States
Countries
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References
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Charles ED, Green RM, Marukian S, Talal AH, Lake-Bakaar GV, Jacobson IM, Rice CM, Dustin LB. Clonal expansion of immunoglobulin M+CD27+ B cells in HCV-associated mixed cryoglobulinemia. Blood. 2008 Feb 1;111(3):1344-56. doi: 10.1182/blood-2007-07-101717. Epub 2007 Oct 17.
Related Links
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Related Info
Other Identifiers
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LDU-0437
Identifier Type: -
Identifier Source: org_study_id