Characterization of Clonal B Cell Populations in HCV Infection
1 other identifier
observational
14
2 countries
2
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2007
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 13, 2007
CompletedFirst Posted
Study publicly available on registry
February 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedAugust 9, 2013
August 1, 2013
6.4 years
February 13, 2007
August 6, 2013
Conditions
Eligibility Criteria
NYC area
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rockefeller Universitylead
- New York Presbyterian Hospitalcollaborator
Study Sites (2)
Rockefeller University Hospital
New York, New York, 10065, United States
Oxford University
Oxford, United Kingdom
Related Publications (1)
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.
PMID: 21421840DERIVED
Related Links
Biospecimen
white blood cells
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lynn Dustin, PhD
Rockefeller University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2007
First Posted
February 14, 2007
Study Start
January 1, 2007
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
August 9, 2013
Record last verified: 2013-08