Gastroenterology and Hepatology Clinical Research | UC Davis Health
Primary Biliary Cholangitis (PBC)
What is PBC?
Primary biliary cholangitis, formerly known as primary biliary cirrhosis, is a rare autoimmune disease in which the immune system attacks the bile ducts within the liver. Normally, the liver produces bile and the bile ducts transport it to the intestines, where it helps digest dietary fats. When the bile ducts are injured, toxic bile acids can build up in the liver, causing progressive liver damage that can lead to cirrhosis and liver failure.
Who is at risk for developing PBC?
PBC affects almost ten times more women than men and most commonly appears between 40 and 60 years of age. People who have family members with PBC are at higher risk, as are those with other autoimmune disorders, such as Sjogren’s syndrome, hypothyroidism and rheumatoid arthritis. Researchers have also found that smoking is associated with a greater risk for developing PBC.
How do I know if I have PBC?
Many PBC patients do not have symptoms and are only diagnosed because of abnormal liver tests done on routine blood tests. The most common symptoms include itching (pruritus), fatigue, and dry eyes and mouth.
PBC is diagnosed when at least 2 of 3 criteria are present: 1) an elevated alkaline phosphatase (ALP) in the blood; 2) a positive anti-mitochondrial antibody (AMA) test; and 3) a liver biopsy consistent with PBC. Because 80-90% of PBC patients have an elevated alkaline phosphatase and a positive AMA, a liver biopsy is rarely required for the diagnosis of PBC.
What are the treatment options for PBC?
While there is currently no cure for PBC, treatment with ursodeoxycholic acid (UDCA or “urso”) slows disease progression. In many PBC patients, liver tests normalize. These PBC patients have a normal life expectancy.
For patients that do not completely respond to UDCA and remain at risk for progression of their liver disease, the only FDA-approved medication is obeticholic acid. New drugs are also being testing in clinical trials, including some at UC Davis, for these PBC patients.
Treatment of PBC symptoms is limited, especially for itching and fatigue. Several new drugs are also being investigated to help relieve these symptoms.
Are there any PBC clinical trials currently recruiting at UC Davis?
Please click here to see our active clinical trials for PBC.
Do I qualify for a PBC clinical trial?
Each clinical trial is a little bit different and the eligibility criteria for each study can vary. You can view eligibility criteria for each study on the clinicaltrials.gov website link above, or contact our Clinical Trials Unit to see if we have a clinical trial that you might qualify for. If you qualify for more than one, we can help you decide which trial is the best for your individual situation. If you don’t qualify, we may have an observational study opportunity available.
Are there other resources available?
The following list contains links to websites with helpful information for PBC patients: