Immune Dysregulation in Hepatitis C Patients With or Without Arthritis

Hepatitis C Patients Clinical Trial

Official title:

Immune Dysregulation in Hepatitis C Patients With or Without Arthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01195987
• Other study ID #: 09-290
• Status: Recruiting
• Phase: N/A
• First received: September 3, 2010
• Last updated: September 7, 2010
• Start date: June 2010
• Est. completion date: August 2011

Study information

• Verified date: September 2010
• Source: The Center for Rheumatic Disease, Allergy, & Immunology
• Contact: Nabih I Abdou, MD, PhD
• Phone: 816-531-0930
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Patients

Locations

Country	Name	City	State
United States	Center for Rheumatic Disease, Allergy & Immunology	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
The Center for Rheumatic Disease, Allergy, & Immunology	St Luke's Hospital

Country where clinical trial is conducted

United States,