NCT00145964

Brief Summary

Primary biliary cirrhosis (PBC) is a disease of the liver, which predominantly affects women. It causes slowly progressive liver disease, which eventually causes liver failure, requiring a liver transplant. Several different studies of large patient cohorts indicate that the cause of this disease is likely due to a combination of factors including genetic and environmental. PBC is associated with several other "autoimmune diseases" - recently a gene has been identified to be abnormal in individuals with another autoimmune liver disease, namely rheumatoid arthritis. This gene usually tells the body when to switch off an immune response. This study plans to identify whether individuals diagnosed with PBC have a similar abnormality in this gene called protein Tyrosine Phosphatase.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
Last Updated

November 29, 2005

Status Verified

August 1, 2005

First QC Date

September 2, 2005

Last Update Submit

November 28, 2005

Conditions

Liver Cirrhosis, BiliaryBiliary Cirrhosis, Primary

Keywords

Biliary Cirrhosis, Primarygenesautoimmune disease

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients attending Liver Clinic at Toronto Western Hospital, Toronto, ON, Canada
  • AMA positive and liver biopsy proven PBC.

You may not qualify if:

  • \- AMA negative PBC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liver Clinic, Toronto Western Hospital, UHN.

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis, BiliaryAutoimmune Diseases

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsImmune System Diseases

Study Officials

  • E.J.L (Jenny) Heathcote, MD

    UHN - Toronto Western Hospital, University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catalina Coltescu

CONTACT

416-603-5832

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 5, 2005

Study Start

August 1, 2004

Last Updated

November 29, 2005

Record last verified: 2005-08

Locations

CA(1)