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Immune Dysregulation in Hepatitis C Patients With or Without Arthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by The Center for Rheumatic Disease, Allergy, & Immunology.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
St Luke's Hospital
Information provided by:
The Center for Rheumatic Disease, Allergy, & Immunology
ClinicalTrials.gov Identifier:
NCT01195987
First received: September 3, 2010
Last updated: September 7, 2010
Last verified: September 2010
History of Changes
  Purpose

The purpose of this study is to study the role of the Immune System in causing arthritis in patients with Hepatitis C.


Condition
Hepatitis C Patients

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immune Dysregulation in Hepatitis C Patients With or Without Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Center for Rheumatic Disease, Allergy, & Immunology:

Estimated Enrollment: 30
Study Start Date: June 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hepatitis C with Arthritis
Hepatitis C without Arthritis

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195987

Contacts
Contact: Nabih I Abdou, MD, PhD 816-531-0930
Contact: Cindy A Greenwell, RN, BSN, CCRC 816-531-0930 cindy@centerforrheumatic.com

Locations
United States, Missouri
Center for Rheumatic Disease, Allergy & Immunology Recruiting
Kansas City, Missouri, United States, 64111
Contact: Cindy A Greenwell, MD, PHD     816-531-0930     cindy@centerforrheumatic.com    
Principal Investigator: Nabih I Abdou, MD, PhD            
Sponsors and Collaborators
The Center for Rheumatic Disease, Allergy, & Immunology
St Luke's Hospital
Investigators
Principal Investigator: Nabih I Abdou, MD, PhD Center for Rheumatic Disease, Allergy & Immunology
  More Information

No publications provided

Responsible Party: Dr. Nabih I Abdou, PhD, Center for Rheumatic Disease, Allergy, & Immunology
ClinicalTrials.gov Identifier: NCT01195987     History of Changes
Other Study ID Numbers: 09-290
Study First Received: September 3, 2010
Last Updated: September 7, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by The Center for Rheumatic Disease, Allergy, & Immunology:
Hepatitis C
Arthritis

Additional relevant MeSH terms:
Arthritis
Hepatitis
Hepatitis A
Hepatitis C
Joint Diseases
Musculoskeletal Diseases
Liver Diseases
 Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on June 17, 2013