Characterization of Clonal B Cell Populations in HCV Infection

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2013-06-30

Brief Summary

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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 cryoglobulinemia (MC). By studying the B cells from HCV-infected individuals with and without MC, as well as from healthy controls, we hope to gain insight into the mechanisms of autoantibody production and develop new strategies for treatment of MC.

Detailed Description

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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 proliferative disorders. We plan to study B cells from individuals chronically infected with HCV as well as from healthy controls. We sort B cells into different types, and we analyze these types for differential levels of gene expression. We are testing the hypothesis that certain types of B cells from subjects with MC have increased expression of genes that allow for increased cell survival.

People interested in participating in this study will have a complete history and general medical examinations before beginning the study. Following the screening, you will have a procedure called leukapheresis, in which white blood cells are removed, but your own red blood cells are returned. The procedure takes approximately 3 hours and is similar to blood donation. The leukapheresis is done during a same day admission to the hospital by an outside blood collection company with trained nurses and certified equipment.

Some aspects of this study are experimental which means the fluid and cells collected will be studied and analyzed to determine more precisely how your body's immune system is responding to the virus. These tests are experimental in that they are not part of the usual routine care of patients.

Conditions

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Hepatitis C

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lynn Dustin, PhD

Role: PRINCIPAL_INVESTIGATOR

Rockefeller University

Locations

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Rockefeller University Hospital

New York, New York, United States

Site Status

Oxford University

Oxford, , United Kingdom

Site Status

Countries

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United States United Kingdom

References

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Charles ED, Brunetti C, Marukian S, Ritola KD, Talal AH, Marks K, Jacobson IM, Rice CM, Dustin LB. Clonal B cells in patients with hepatitis C virus-associated mixed cryoglobulinemia contain an expanded anergic CD21low B-cell subset. Blood. 2011 May 19;117(20):5425-37. doi: 10.1182/blood-2010-10-312942. Epub 2011 Mar 18.

Reference Type DERIVED

PMID: 21421840 (View on PubMed)

Other Identifiers

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ECH-0596

Identifier Type: -

Identifier Source: org_study_id