Primary Biliary Cholangitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years of age or older
• You have been diagnosed with Primary Biliary Cholangitis (PBC) according to recognised medical guidelines
• You experience moderate to severe fatigue, measured by scoring 29 points or more on a specific PBC fatigue questionnaire called the PBC-40

Who may not be able to join:

• You are older than 80 years of age
• You experience severe itching (confirm with trial site)
• Your liver disease has reached an advanced stage where the liver can no longer function properly (called decompensated cirrhosis)
• You have a liver condition caused by something other than PBC
• You have had a liver transplant, or you are currently on a waiting list for one
• You have a thyroid condition that is not well controlled by treatment
• You have anaemia with a haemoglobin blood level below 11g/dl (a measure of low red blood cells)
• You have heart or cardiovascular risk factors that are not well managed
• Your Body Mass Index (BMI), a measure of body weight relative to height, is above 35
• You have had a heart attack or unstable chest pain (angina) in the past 6 months
• You have a muscle disease or a condition that may affect your muscles
• You have a condition affecting your body's automatic functions such as heart rate or blood pressure (confirm with trial site)
• You have osteoporosis that has not been treated
• You have coeliac disease that has not been treated
• You drink more than 14 standard alcoholic drinks per week if you are a woman, or more than 21 per week if you are a man
• You have moderate to severe chronic kidney disease (stage 4 or higher on the KDIGO scale)
• You have had cancer in the past two years, with the exception of certain types of non-serious skin cancer or early-stage cervical cancer
• You are not able to take part in or follow the exercise and preparation programme involved in this trial
• You have taken part in another clinical trial in the past 2 months
• You are unwilling to give your formal written agreement (informed consent) to take part

For a specific part of the study looking at the causes of fatigue, additional criteria may apply:

• You have severe depression or a serious mental health condition
• You take medications that act on the brain or central nervous system
• You have a muscle or systemic disease that may affect the muscles
• You take medication that suppresses the immune system
• You have a sleep disorder
• Your BMI is above 30 (a lower threshold than the main study)

Important: Always verify eligibility with the trial site directly before applying.