NCT00219999

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2001

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

11.7 years

First QC Date

September 19, 2005

Last Update Submit

August 6, 2013

Conditions

Keywords

HepatitisHepacivirusB LymphocytesChemokinesAntibodies

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (5)

HCV infection

current HCV infection, including intravenous drug users

cryoglobulinemia

cryoglobulinemia and without HCV infection

chronic liver disease

chronic liver disease not due to hepatitis C virus infection

Sustained Virologic responders

successfully treated for HCV infection

normal

normal, healthy volunteers

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinics of doctors at NYPH and the NYC metropolitan area

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rockefeller University Hosital

New York, New York, 10021, United States

Location

Related Publications (1)

  • 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

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Hepatitis CHepatitis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsLiver DiseasesDigestive System Diseases

Study Officials

  • Lynn B Dustin, PHD

    Rockefeller University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2005

First Posted

September 22, 2005

Study Start

September 1, 2001

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

August 9, 2013

Record last verified: 2013-08

Locations