Medical Research

The Foundation is very proud of its record in funding and facilitating research on PBC. It has uniquely funded a number of projects and started the ball rolling on others.

Current research opportunities

The KLEAR Clinical Research Study

The KLEAR Clinical Research Study needs your help to determine whether an investigational drug called CR845 works to reduce itching in adults who have primary biliary cholangitis (PBC).

For further information and to see if you qualify to participate, please click here.

OACS-1 Trial led by Professor David Jones OBE 

We are delighted to share details of a new UK based trial, "Obeticholic Acid for the Amelioration of Cognitive Symptoms trial - 1" designed to find out whether taking a drug known as Obeticholic Acid has any impact on the symptoms of "brain fog", poor memory, concentration or fatigue in patients with PBC.

For more information, please click here.

The RESPONSE study

The RESPONSE study is enrolling patients who have been using ursodeoxycholic acid (UDCA or ursodiol) but have not achieved the recommended treatment goal or who developed troublesome side effects from UDCA that prevent them from continuing to take this treatment. The study will evaluate if seladelpar can improve PBC-related blood laboratory tests and can improve symptoms of PBC, such as itching. 

For more information and your opportunity to participate, click here.

 

Current surveys

Clinical Trial Preferences Survey

New Patient Survey about clinical trial preferences for tracking symptoms. We are working closely with research teams to develop new treatments for PBC symptoms and are seeking your important input.. For more information please click here. 

Patient Experience Survey available on the PBC Foundation App

The PBC Foundation is working hard on your behalf to improve the treatment and care you receive. To this end, it is vital that we understand the patient experience of the PBC clinical journey to identify your unmet needs. For more information please click here. 

 

Previous research

One of the most successful in funded studies was "PBC 40" project, in conjunction with the University of Newcastle and Liverpool. This produced a 40 questions tool that measures the quality of life of PBC in a scientifically valid way.

We also were fortunate enough to be bequeathed a sum of money that should be used to finance a PBC research project. This project is in progress at Norwich Hospital and the University of Norfolk and is looking at what happens with biliary cells when they become inflamed and injured, as occurs in PBC.

The study most successful we have been involved in is the original PBC Study Genetics based in Addenbrookes Hospital in Cambridge. This study used DNA samples from thousands of patients across the UK to help identify the genetic reasons why someone develops PBC. The success of this study led to a broader study that is called UK-PBC (www.uk-pbc.com). These are groups around the UK (Newcastle, Birmingham, Cambridge, and Imperial College in London among many) that work together to combat the lack of new treatments for patients. Within this involvement patient study is fundamental, and includes opportunities to further genetic collection, studies bear why not work for everyone, and most importantly, in many respects, opportunities to participate in new drug trials for PBC (including symptoms ). All who participated in the original study of genetics will be notified about it, and new patients are encouraged to participate if they have not been invited by their doctors to do so. Patients can ask their own doctor about it, or contact direct UK-PBC (01223 769 088).

The PBC Foundation was also involved in educating not only patients but also doctors. An example from 2014 is a conference where doctors learn about autoimmune liver disease patients and ear specialists not only clinical.

The exciting thing about research is how it spans so much, and how anyone can participate, either by answering a few questions about your symptoms, all the way to trying new drugs, if necessary.

Title	Researcher	Commenced	Completed	Amount	Grant/Award
Investigation into the Pathogenesis of Primary Biliary Cirrhosis	Professor James Neuberger, Queen Elizabeth Hospital, Birmingham	October 1997	September 2000	£75,000	In conjunction with British Liver Trust
These studies have provided a robust way of isolating and maintaining in culture human biliary epithelial cells (the main site of damage in PBC) so that laboratory studies can be carried out to investigate further the relationship between AMA and PBC.
Establishment of PBC Database	Professor Oliver James, Freeman Hospital, Newcastle	1997	1998	£10,000	Raised by Members of the PBC Foundation
This allowed the creation of a national database. As well as allowing the formation of a database that will provide more information about people in the UK with PBC but also showed that doctors can work together effectively.
Improving the Assessment of Outcome in Primary Biliary Cirrhosis	Professor Ann Jacoby, University of Liverpool Professor David Jones, University of Newcastle	February 2000	January 2003	£128,400	Community Fund
Development of the Health-Related Quality of Life Measure, namely the PBC 40
Newly Discovered Microbial Mimics as Triggers of PBC	Professor Diego Vergani, Royal Free and University College Medical School, University College London	March 2000	August 2001	£5,000	Bequeathed by Edgar Ernest of Dorset
These studies looked at whether microbes (such as some bacteria) can confuse the body’s immune system so that instead of reacting with microbes, the immune system attacks similar targets in the liver. They showed that there may be cross-reaction with a number of bacteria, which could trigger PBC in some individuals.
The Role of the Pregnane X receptor in Primary Biliary Cirrhosis Pathogenesis	Dr Matthew C Wright, University of Aberdeen	October 2003	October 2006	£75,000	Raised by Members of the PBC Foundation
This study looked at a protein called PXR and studied whether activation of this inhibits inflammation in the liver.   Since PXR activation promotes hepatocyte growth and is also anti-fibrogenic, the PXR may be an excellent drug target for the treatment of chronic inflammatory liver disease and PBC.
Genetic Study into Primary Biliary Cirrhosis	Dr George Mells Dr Graeme Alexander Dr Richard Sandford	June 2008       In progress		£50,000	Raised by Members of the PBC Foundation
The PBC Genetics Study was a UK-wide initiative to establish the UKPBC Research Cohort, a cohort of more than 4000 PBC patients for population-level research, including large-scale genetic studies. DNA samples obtained from the UKPBC Research Cohort were used for a genome-wide association study of PBC in 2010 and an iCHIP study of PBC in 2012. The PBC Genetics Study has now evolved into the UKPBC Project, which is broader in its ambition to elucidate the biological origins of PBC.
Role of Biliary Senesence in Cholestatic Liver Disease	Dr Simon Rushbrooke & Dr GJ Alexander Norfolk & Norwich University Hospital	March 2012	In progress	£80,000	Bequeathed by Barbara Greaves (Fellowship Award)
This programme is currently underway.