Birmingham and Newcastle Cohort Study in Primary Biliary Cirrhosis
Research type
Research Study
Full title
Birmingham and Newcastle Cohort Study of Primary Biliary Cirrhosis:A two centre proof-of concept study in Primary Biliary Cirrhosis (PBC)
IRAS ID
156064
Contact name
David Jones
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Research summary
Primary Biliary Cirrhosis (PBC) is a disease that mostly affects women and which becomes more common with age. It is an autoimmune disease where the body's immune system attacks its own cells. In the case of PBC, the cells that come under attack are those of the bile ducts that are damaged over years. The bile ducts carry bile away from the liver. If they are damaged, the bile cannot flow properly and the liver becomes progressively more scarred as a result. Although the drug ursodeoxycholic acid (UDCA) can slow the process in about two thirds of patients, the remainder worsen and may need liver transplantation. As well as the severe damage to the liver that can occur in PBC, patients often suffer debilitating fatigue and itching. These often begin well become significant damage occurs to the liver.
This study aims to systematically collect samples of serum from the blood of PBC patients to try and answer the following questions:
1. As mentioned above, only some patients respond to UDCA. However, to know whether a patient has responded, typically one year's treatment is required. By analysing serum, we may find new ways of predicting whether an individual patient may respond earlier than a year.
2. We also hope to look for chemical signatures in the serum that relate to long-term prognosis. This will help clinicians give valuable information to patients at diagnosis and will be of use in future clinical trials.
3. It remains unknown what causes the itching and fatigue in PBC. By looking for chemicals in the blood and relating their levels to scores of itching and fatigue, we hope to identify possible candidates. If successful, this will be useful in guiding new therapy and further development of therapies for these unpleasant symptoms.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/1140
Date of REC Opinion
9 Jul 2014
REC opinion
Favourable Opinion