Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT03722576) enrolled 18 people, all of whom received a treatment called vidofludimus calcium. Eleven participants completed the study, while seven did not finish. The trial was looking at changes in certain liver-related blood markers — specifically alkaline phosphatase (ALP, an enzyme linked to liver and bone activity) and aspartate aminotransferase (AST, an enzyme linked to liver and muscle cells) — to see how levels of these substances changed over 24 weeks. The reported data shows that for the main (primary) outcome, 3 out of the 18 participants met the combined target: a drop of 25% or more in their ALP levels alongside an increase of no more than 33% in their AST levels at the 24-week mark. For the secondary outcomes, the reported data shows that 8 participants had AST levels outside the normal range, and 8 participants had ALT levels (another liver enzyme) outside the normal range. Three participants had total bilirubin levels (a pigment processed by the liver) outside the normal range, and 4 participants had direct bilirubin levels outside the normal range. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Primary Biliary Cholangitis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are between 18 and 75 years old
- You have been diagnosed with a liver condition called Primary Sclerosing Cholangitis (PSC), confirmed by specific blood tests and imaging of your bile ducts
- Your blood test shows a certain liver enzyme (called ALP) is at least 1.5 times higher than the normal range
- Your bilirubin level (a substance measured in blood) is below 1.2 times the upper limit of normal
- You have had an ultrasound or similar scan within the last 6 months that ruled out bile duct blockage and cancer
- You may have PSC with or without inflammatory bowel disease, such as ulcerative colitis or Crohn's disease
- You are willing to follow the study rules and give your written agreement to take part
Who may not be able to join:
- You are pregnant, trying to become pregnant, or currently breastfeeding
- You have an active hepatitis A or B infection
- You have an active hepatitis C infection (though a past hepatitis C infection may be acceptable if the virus is no longer detectable — confirm with trial site)
- You have HIV/AIDS, tuberculosis, or a positive test result suggesting tuberculosis exposure
- You have another type of liver disease affecting bile flow, such as primary biliary cholangitis or a liver condition related to pregnancy
- You have a metabolic liver disease such as Wilson's disease, Gilbert's syndrome, or hemochromatosis
- Your uric acid blood level is more than 1.2 times the upper limit of normal
- You have an inherited liver disease such as alpha-1 antitrypsin deficiency
- You have a specific condition called IgG4-related cholangitis (confirm with trial site)
- You have PSC alongside autoimmune hepatitis and/or primary biliary cholangitis
- You have a secondary form of sclerosing cholangitis (caused by another condition rather than PSC itself)
- You currently have an active bile duct infection that requires antibiotics
- You have or have had a type of bile duct cancer called cholangiocarcinoma
- A previous liver biopsy showed a condition called NASH (a type of liver damage related to fat build-up)
- You have serious complications from advanced PSC, such as confusion caused by liver failure, high blood pressure in the liver's blood vessels, or liver-related kidney or lung problems
- You have previously had a liver transplant, are expected to need one within the next 12 months, or your liver disease severity scores are above certain limits (confirm with trial site)
- You drink more than 4 alcoholic drinks per day (men) or more than 2 per day (women)
- Your kidneys are not working well enough, based on a specific measurement of kidney function
- You have had a C. difficile gut infection within the past 30 days, or currently have an active C. difficile infection
- You have been treated for another gut infection (other than C. difficile) within the past 30 days
- You have received or plan to receive a live vaccine within 30 days before or during the study
- You are taking methotrexate at a dose of 17.5 mg per week or higher
- You are taking more than 10 mg per day of a cholesterol medication called rosuvastatin
- You have any other health condition that the study doctor believes could put you at risk or affect your participation (confirm with trial site)
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Subjects Who Experience a Positive Outcome as Measured by Combination of Serum Alkaline Phosphatase (ALP) and Aspartate Aminotransferase (AST) Levels.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.