Immune Dysregulation in Hepatitis C Patients With or With... | NCT01195987

Studies
Immune Dysregulation in Hepatitis C Patients With or Without Arthritis

NCT01195987

Sponsor

The Center for Rheumatic Disease, Allergy, & Immunology

Status

Unknown status

Last Update Posted

Sep 8, 2010Estimated

Enrollment

30Estimated

Phase

Not provided

Conditions

Hepatitis C Patients

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Aug 2011Estimated

Completion Date

Aug 2011Estimated

First Submitted Date

Sep 3, 2010

First Submission Date that Met QC Criteria

Sep 7, 2010

First Posted Date

Sep 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2010

Last Update Posted Date

Sep 8, 2010Estimated

Name	Class
St. Luke's Hospital	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nabih I Abdou, MD, PhD	Contact	816-531-0930
Cindy A Greenwell, RN, BSN, CCRC	Contact	816-531-0930		cindy@centerforrheumatic.com

Overall Officials

Name	Affiliation	Role
Nabih I Abdou, MD, PhD	Center for Rheumatic Disease, Allergy & Immunology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Rheumatic Disease, Allergy & Immunology	Recruiting	Kansas City	Missouri	64111	United States

Condition Browse Module

MeSH Terms

ID	Term
D006526	Hepatitis C
D001168	Arthritis

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Hepatitis C with Arthritis
Hepatitis C without Arthritis