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 (NCT01389973) enrolled 20 participants, all of whom received a medicine called ustekinumab (90 mg) in an open-label study — meaning everyone knew which treatment they were receiving. The trial was looking at whether the drug could reduce blood levels of a liver enzyme called alkaline phosphatase (ALP), which can be a marker of a liver condition. Notably, the reported data shows that none of the 20 participants were recorded as having completed the study. The reported data shows that the main thing the trial was measuring — whether a participant's ALP level dropped by more than 40% from their starting level by week 12 — was seen in zero out of 20 participants. The same result was reported at week 28: zero participants met the threshold for an ALP "response" (a large drop in the enzyme), and zero participants achieved ALP "remission" (a return to a lower, less concerning level). However, the reported data does show a small average percentage change in ALP levels at week 28 of around -11%, meaning levels were slightly lower on average than at the start, though this did not reach the target reduction. Three other liver-related measures — ALT, AST, and bilirubin — also showed small average reductions of around -9%, -7%, and -5% respectively at week 28, though again these figures simply reflect what was measured and recorded. 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 ↗ · Read the linked publication on PubMed (PMID 25543678) ↗
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 have been diagnosed with, or are likely to have, a liver condition called Primary Biliary Cirrhosis (PBC)
- You have been taking a stable dose of a medication called ursodeoxycholic acid for at least 6 months before the start of the trial
- A specific liver enzyme in your blood (called alkaline phosphatase) is above a certain level, as shown in a screening blood test
- Your other blood test results from screening fall within the ranges required by the trial
- You have no history of tuberculosis (TB), either past or current, and no current signs or symptoms of TB
Who may not be able to join:
- You have a history of bleeding in your digestive system related to liver disease, or have had a build-up of fluid in the abdomen requiring water tablets, or have had episodes of confusion caused by liver problems
- A specific substance in your blood called direct bilirubin was above a certain level in your screening blood test
- A liver biopsy has previously shown a type of liver disease called steatohepatitis, or you are considered at high risk of developing it
- A liver biopsy has previously shown a condition called autoimmune hepatitis, or you are considered at high risk of a related overlap condition (confirm with trial site)
- You have tested positive for a marker of Hepatitis B infection in your blood
- You have taken certain medications — including colchicine, methotrexate, azathioprine, or steroid tablets/injections — within the 3 months before the trial begins
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
Part 1: Number of Participants With Alkaline Phosphatase (ALP) Response at Week 12
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.