Primary Biliary Cirrhosis Clinical Trial
Official title:
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 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.
In this study, the investigators will prospectively collect demographic, clinical, and laboratory data and blood samples for research purposes on 45 PBC patients and 50 male and female NAFLD patients. PBC and NAFLD diagnosis and clinical status will be evaluated by magnetic resonance (MR) elastography, transient elastography (FibroScan®) and blood lab analysis including anti-mitochondrial antibodies (AMA), anti-nuclear antibodies (ANA), immunoglobulins, complete blood count (CBC), comprehensive metabolic panel (CMP) and coagulation measures). Additionally serum and blood will be obtained from the patients on the first visit and at months 3, 6, 9, 12, 15, 18, 21 & 24. Serum and blood samples will be used to measure serum cytokine abundance and transcriptome analysis. For comparison, 95 age (+/- 5 years) and sex-matched controls without PBC will be recruited for a clinical laboratory, cytokine, gene expression analysis. Control subjects will have blood drawn at a single time point. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04526665 -
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
|
Phase 3 | |
Recruiting |
NCT02931513 -
sCD163 in PBC Patients - Assessment of Treatment Response
|
||
Active, not recruiting |
NCT02924701 -
sCD163 in PBC Patients - Assessment of Disease Severity and Prognosis
|
||
Completed |
NCT02659696 -
Nalfurafine Hydrochloride for Pruritus in Patients With Primary Biliary Cholangitis
|
||
Completed |
NCT02078882 -
Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis
|
Phase 4 | |
Completed |
NCT01389973 -
A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
|
Phase 2 | |
Completed |
NCT01603199 -
High-protein High-fiber Diet in Patients With Primary Biliary Cirrhosis
|
N/A | |
Completed |
NCT01857284 -
Safety and Efficacy of Tauroursodeoxycholic Acid Versus Ursofalk in the Treatment of Adult Primary Biliary Cirrhosis
|
Phase 3 | |
Completed |
NCT05374200 -
Mind-body Wellness Intervention in Primary Biliary Cholangitis (PBC)
|
N/A | |
Recruiting |
NCT02937012 -
Use of Bezafibrate in Patients With Primary Biliary Cirrhosis to Archive Complete Biochemical Response in Non-responders
|
Phase 3 | |
Completed |
NCT02376335 -
B-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary Cirrhosis
|
Phase 2 | |
Recruiting |
NCT01662973 -
Umbilical Cord Mesenchymal Stem Cells for Patients With Primary Biliary Cirrhosis
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04751188 -
A Study to Assess Efficacy and Safety of Bezafibrate in Patients With Primary Biliary Cholangitis
|
Phase 3 | |
Recruiting |
NCT04514965 -
Bezafibrate in Patients With Primary Biliary Cholangitis (PBC)
|
||
Recruiting |
NCT03668145 -
Mesenchymal Stem Cell Transplantation for Refractory Primary Biliary Cholangitis
|
N/A | |
Completed |
NCT02955602 -
Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)
|
Phase 2 | |
Completed |
NCT02557360 -
Effectiveness of S-adenosyl-L-methionine in Patients With Primary Biliary Cirrhosis
|
Phase 4 | |
Recruiting |
NCT01440309 -
Efficacy and Safety Study of Allogenic Mesenchymal Stem Cells for Patients With Refractory Primary Biliary Cirrhosis
|
Phase 1 | |
Completed |
NCT01249092 -
Pentoxifylline for Primary Biliary Cirrhosis
|
Phase 2 | |
Completed |
NCT01510860 -
Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis
|
Phase 4 |