Identification of Inflammatory and Fibrotic Biomarkers in PBC and NAFLD Patients
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|ClinicalTrials.gov Identifier: NCT02477462|
Recruitment Status : Recruiting
First Posted : June 22, 2015
Last Update Posted : March 1, 2018
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.
|Condition or disease||Intervention/treatment|
|Primary Biliary Cirrhosis||Other: Clinic visit Other: Baseline visit|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Identification of Inflammatory and Fibrotic Biomarkers in PBC and NAFLD Patients|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||May 2019|
Primary Biliary Cirrhosis
Subjects meeting internationally accepted criteria for the diagnosis of primary biliary cirrhosis
Other: Clinic visit
Blood draw every 3 months; quality of life surveys and imaging annually
Subjects without evidence of primary biliary cirrhosis, liver disease, or inflammatory condition who are of similar age and sex distribution to the Primary Biliary Cirrhosis group
Other: Baseline visit
Blood draw and quality of life surveys
- Phenotypic Analysis [ Time Frame: 2 years ]Comparison of PBC phenotypes defined by alkaline phosphatase response to treatment and degree of fibrosis determined by transient elastography. In addition, Principle component analysis (PCA) and non-negative matrix factorization (NMF) will be used to identify phenotypic subject stratification utilizing both cytokine and gene expression data at baseline. The alkaline phosphatase (ALP) will be compared between these classes to determine if there is an association between classes.
- Liver Imaging Analysis [ Time Frame: 2 years ]Transient elastography (FibroScan) and MR elastography will provide a measurement of liver stiffness. The liver stiffness metrics will be tabulated for each of the three time points and assessed for change.
- Phlebotomy Injuries [ Time Frame: 2 years ]Number of injuries occurring as a result of phlebotomy during the study.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02477462
|Contact: Christopher L Bowlus, MDfirstname.lastname@example.org|
|Contact: Christopher E Bowlus, MDemail@example.com|
|United States, California|
|University of California Davis Medical Center||Recruiting|
|Sacramento, California, United States, 95817|
|Contact: Sandeep Dhaliwal, MD 916-734-8696 firstname.lastname@example.org|
|Principal Investigator: Christopher L Bowlus, MD|
|Principal Investigator:||Christopher L Bowlus, MD||University of California, Davis|