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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00219999
Other study ID # LDU-0437
Secondary ID R01AI060561
Status Completed
Phase N/A
First received September 19, 2005
Last updated August 6, 2013
Start date September 2001
Est. completion date May 2013

Study information

Verified date August 2013
Source Rockefeller University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The purpose of this study is to measure specific chemokines, antibodies, and antibody-producing B cells in the blood of patients with hepatitis C virus (HCV) infection. Our hypothesis is that changes in chemokine levels affect the development of an effective immune response against HCV.


Description:

The long-term goal of our research is to understand why immune complexes (ICs) are produced in patients infected with HCV, and whether these complexes affect virus interaction with target cells. We have found that many patients infected with HCV have an increased frequency of circulating B cells, but no evidence that the increased B cells are activated of proliferating. One possible mechanism for such an increase would be a change in levels of chemokines that influence B cell localization and trafficking. Our studies are aimed at testing the following hypotheses:

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.


Recruitment information / eligibility

Status Completed
Enrollment 161
Est. completion date May 2013
Est. primary completion date May 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Healthy volunteers, no liver disease

- 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:

- Any medical condition that, in the opinion of the investigators, precludes the patient's participation

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Rockefeller University Hosital New York New York

Sponsors (3)

Lead Sponsor Collaborator
Rockefeller University National Institute of Allergy and Infectious Diseases (NIAID), New York Presbyterian Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Define the relationships between HCV infection, B cell phenotype, and B cell function Define the relationships between HCV infection, B cell phenotype, and B cell function 5 years No
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