Phase 2 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 (any gender)
• You have been diagnosed with a liver condition called PBC (Primary Biliary Cholangitis), confirmed by at least 2 out of 3 key signs of the disease
• You experience significant fatigue related to PBC, scoring 29 or above on a specific PBC fatigue questionnaire used at your screening visit
• You experience significant mental "brain fog" or thinking difficulties related to PBC, scoring 16 or above on a specific PBC cognitive questionnaire used at your screening visit
• If you are taking standard PBC medication, your dose has been stable for at least 3 months before joining the trial
• If you are a woman who could become pregnant, you must have a negative pregnancy test at your screening and baseline visits
• If you are a woman who could become pregnant, you must be willing to use a highly reliable form of contraception (less than 1% failure rate) during the study and for 1 month after your last dose
• If you are a woman who cannot become pregnant, you must have documented evidence of tubal ligation, hysterectomy, or be post-menopausal
• If you are a man who could father a child, you must be willing to use a condom and ensure your female partner also uses a highly reliable form of contraception
• You are willing and able to give your informed consent to take part
• You are assessed by the study doctor as being clear-minded and aware of yourself, your surroundings, and the situation when giving your consent

Who may not be able to join:

• You have moderate or severe liver scarring (cirrhosis classified as Child-Pugh class B or C)
• You have had or currently have signs of serious liver failure, such as confusion caused by liver disease, fluid build-up in the abdomen, or bleeding from swollen veins in the food pipe
• You have a history of liver cancer
• Your bilirubin (a liver-related blood marker) is above a certain level (more than 1.5 times the upper limit of normal)
• Your kidney function is below a certain level (confirm with trial site)
• You have moderate or severe anaemia (low red blood cell levels)
• You have low levels of vitamin B12 or folate in your blood
• There is evidence of a blockage in your bile ducts
• You have tested positive for HIV or hepatitis B
• You have an irregular heart rhythm or a specific abnormality on a heart tracing (ECG) at your screening visit
• You have another condition that also causes long-term tiredness and/or thinking/memory difficulties
• You have a significant bowel condition, such as a blockage, active inflammatory bowel disease, or problems absorbing nutrients
• You have significant sleep apnoea (breathing interruptions during sleep)
• You have a thyroid condition that is not well controlled
• You have an active or uncontrolled immune system disorder (other than PBC), including autoimmune diseases, or you require medication that suppresses your immune system
• You have been diagnosed with a condition where PBC overlaps with another type of liver disease called autoimmune hepatitis
• You have another serious illness that the study doctor believes could put you at risk or affect the study results
• You regularly take prescribed or over-the-counter medicines known to cause fatigue or affect thinking and memory
• You have taken certain prohibited medications within 14 days before joining the trial
• It is expected that your PBC medication will change, or that you will have a major medical procedure or surgery, during the study
• You regularly drink more than 14 units of alcohol per week for more than one week per month
• You have taken part in another clinical drug trial within the last 3 months
• You are pregnant, breastfeeding, or actively trying to become pregnant
• You would be unable to swallow the required number of trial capsules
• You have a history of or currently have a severe allergic reaction, as judged by the study doctor

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