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NCT02477462 · ClinicalTrials.gov registry record
Identification of Inflammatory and Fibrotic Biomarkers in PBC and NAFLD Patients
A clinical trial of Primary Biliary Cirrhosis, sponsored by University of California, Davis.
- Completed
- Registry status
- 124
- Enrollment target
- 1
- Study location
NCT02477462 is a study of Primary Biliary Cirrhosis that has completed, run by University of California, Davis. The registered enrollment target is 124 participants, below the 1,424-participant average among 7 other Primary Biliary Cirrhosis trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02477462, a study of Primary Biliary Cirrhosis, has completed, sponsored by University of California, Davis.
- COMPLETED
- Registry status
- 124 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- OTHER Clinic visit
- OTHER Baseline visit
Study Locations (1)
California
- University of California Davis Medical Center - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2015-05 |
| Est. Completion | 2019-06-06 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02477462
The ClinicalTrials.gov registry entry for NCT02477462 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 124 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,424-participant average among 7 other Primary Biliary Cirrhosis trials with a reported enrollment target (91% lower). The listed sponsor is University of California, Davis, which has 657 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Biliary Cirrhosis appearing as the primary indexed condition, and to 2 interventions - of which Clinic visit is the first listed.
NCT02477462 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT02477462 about?
NCT02477462 is a clinical study titled "Identification of Inflammatory and Fibrotic Biomarkers in PBC and NAFLD Patients". 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 subun...
What is the current status of trial NCT02477462?
This trial is currently completed. The enrollment target is 124 participants. The study started on 2015-05. Estimated completion is 2019-06-06.
What conditions does trial NCT02477462 study?
This clinical trial studies the following conditions: Primary Biliary Cirrhosis.
What interventions are being tested in trial NCT02477462?
The interventions under investigation include: Clinic visit (OTHER), Baseline visit (OTHER).
Who is sponsoring clinical trial NCT02477462?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02477462 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
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