Immune Dysregulation in Hepatitis C Patients With or Without Arthritis

September 7, 2010 updated by: The Center for Rheumatic Disease, Allergy, & Immunology
The purpose of this study is to study the role of the Immune System in causing arthritis in patients with Hepatitis C.

Study Overview

Status

Unknown

Conditions

Detailed Description

Patients will provide one blood sample after qualifying for the study, and signing consent. The patients will have a skin test TB, Candida, and Trichophyton placed and will read the results themselves and mail back the card with the measurements to be recorded. Labs will test for ESR, CBC, CRP, antiCCP, Cryoglobulins, RF, CH50, C3, C4, Flow cytometry, and would have already been tested for HIV and Hepatitis C.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Nabih I Abdou, MD, PhD
  • Phone Number: 816-531-0930

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Center for Rheumatic Disease, Allergy & Immunology
        • Principal Investigator:
          • Nabih I Abdou, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hepatitis positive patients with and without osteoarthritis, with a group of Hepatitis C negative and no osteoarthritis to serve as controls.

Description

Inclusion Criteria:

  • All adults 18 or older, 20 will have hep C positive with a viral load withen 6 mo. of enrollment.
  • Either interferon or antiviral naive or those who failed interferon or antiviral therapy more than 6 mo. prior to enrollment.
  • 10 normal healthy controls- Hep C neg and without osteoarthritis (OA).

Exclusion Criteria:

  • HIV patients
  • Those with concomitant alcoholic liver disease
  • Patients with Rheumatoid Arthritis (RA) or other autoimmune disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Hepatitis C with Arthritis
Hepatitis C without Arthritis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Center for Rheumatic Disease, Allergy, & Immunology

Collaborators

St. Luke's Hospital

Investigators

  • Principal Investigator: Nabih I Abdou, MD, PhD, Center for Rheumatic Disease, Allergy & Immunology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

August 1, 2011

Study Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

September 3, 2010

First Submitted That Met QC Criteria

September 7, 2010

First Posted (Estimate)

September 8, 2010

Study Record Updates

Last Update Posted (Estimate)

September 8, 2010

Last Update Submitted That Met QC Criteria

September 7, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-290

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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