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Identification of Inflammatory and Fibrotic Biomarkers in PBC and NAFLD Patients

NCT02477462 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 124

Last updated 2019-06-11

No results posted yet for this study

Summary

Primary biliary cirrhosis (PBC) is a progressive autoimmune disease of biliary epithelial cells resulting in biliary cirrhosis. PBC is characterized by a 90% female predominance, high titers of serum anti-mitochondrial autoantibodies (AMA) directed against the pyruvate dehydrogenase complex E2 subunit and evidence from both human and murine models suggests that T-cells, particularly cluster of differentiation (CD) 8+ T cells, are key to the destruction of bile ducts. However, clinical trials of classic immunosuppressive drugs including corticosteroids, azathioprine, methotrexate, and tacrolimus have been largely unsuccessful in altering the disease course. This is a single center, prospective, non-treatment study of the role of immune responses in PBC patients.

Non-alcoholic fatty liver disease (NAFLD) and its more severe form, non-alcoholic steatohepatitis (NASH) are common, often "silent" liver diseases. NASH resembles alcoholic liver disease, but occurs in people who drink little or no alcohol. The major feature in NASH is fat in the liver, along with inflammation and fibrosis. NASH can be severe and can lead to cirrhosis and hepatocellular carcinoma. Ten to 20 percent of American have NAFLD with NASH affecting 2 to 5 percent of Americans.

Conditions

  • Primary Biliary Cirrhosis

Interventions

OTHER

Clinic visit

Blood draw every 3 months; quality of life surveys and imaging annually

OTHER

Baseline visit

Blood draw and quality of life surveys

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Christopher L Bowlus, MD · University of California, Davis

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2019-06-06
Completion
2019-06-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02477462 on ClinicalTrials.gov