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 involved people with a liver condition and was split into two phases. In the first phase (the "double-blind" phase), 217 participants were divided into three groups: one group received a dose of obeticholic acid (OCA) that could be adjusted between 5 mg and 10 mg, one group received a fixed 10 mg dose of OCA, and one group received a placebo (a dummy treatment with no active ingredient). Neither the participants nor the researchers knew who was receiving which treatment during this phase. After this 12-month phase, participants who wished to continue moved into a longer follow-up phase (called the LTSE phase), where 193 people received OCA for up to a further four years. The trial was measuring changes in two specific blood markers — alkaline phosphatase (ALP) and bilirubin — which are substances the liver produces that can be measured with a blood test. The reported data shows that at the end of the 12-month double-blind phase, 47% of participants in the fixed 10 mg OCA group met a specific combined blood-marker target (ALP below a certain level, bilirubin within normal range, and at least a 15% drop in ALP from the start), compared with 10% of participants in the placebo group. For the adjustable 5–10 mg OCA group, 46% met that same combined target at 12 months, versus 10% in the placebo group. In terms of the actual change in ALP levels, the reported data shows the adjustable-dose group had an average decrease of about 113 units per litre (U/L) and the fixed 10 mg group had an average decrease of about 130 U/L, while the placebo group had an average decrease of about 14 U/L. During the longer follow-up phase, the reported data shows that the proportion of participants meeting the combined blood-marker target generally increased over time across all groups — including among those who had originally been on placebo and switched to OCA — reaching around 54–61% at the later time points, though the data for some sub-groups at earlier time points was more variable. 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 27532829) ↗
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 3 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 Cholangitis (PBC), shown by at least 2 of these 3 things: abnormal liver enzyme (ALP) levels for at least 6 months, a positive blood test for certain antibodies linked to PBC, or a liver biopsy that fits with PBC.
- Your blood test results show that your ALP level is at least 1.67 times the upper end of normal, OR your total bilirubin level is above normal but less than twice the upper limit of normal.
- You are 18 years of age or older.
- You have been taking a medicine called ursodeoxycholic acid (UDCA) for at least 12 months at a stable dose for the last 3 months, OR you cannot tolerate UDCA and have not taken it for at least 3 months before the start of the trial.
- If you are a woman who could become pregnant, you are willing to use at least one reliable form of birth control during the trial and for 30 days after treatment ends (acceptable methods include hormonal contraception, double barrier methods, an IUD, your partner having had a vasectomy, or abstinence); women who are past menopause or have had surgery to prevent pregnancy also qualify.
- You are willing to sign a consent form and follow the trial's rules and schedule.
Who may not be able to join:
- You have or have had another liver disease at the same time, such as hepatitis C, active hepatitis B, alcoholic liver disease, autoimmune hepatitis, a condition called NASH (fatty liver disease with inflammation), primary sclerosing cholangitis, or a condition called Gilbert's Syndrome.
- You have had a liver transplant, are on a waiting list for one, or your liver disease has been scored as quite severe (MELD score of 15 or higher).
- You have serious complications from PBC, such as high blood pressure in the liver's blood vessels, bleeding from swollen veins in the stomach or food pipe, fluid build-up in the abdomen that is hard to treat, or confusion caused by liver problems.
- You have cirrhosis with serious complications, including a liver cancer history, a serious type of kidney failure linked to liver disease, or bilirubin levels more than twice the upper limit of normal.
- You have severe itching from PBC, or you have needed prescription medicines to treat itching within the past 2 months before the trial starts.
- You have taken certain medicines in the months before the trial, including some immune-suppressing drugs, fibrates (a type of cholesterol medicine), certain steroids, or some antibody-based treatments — specific time restrictions apply to each (confirm with trial site).
- You have taken part in a previous clinical trial of the study drug (OCA).
- You have a significant heart rhythm problem, or a specific measurement of your heart's electrical activity (QT/QTc interval) is too high on your screening tests.
- You are pregnant, have a positive pregnancy test, or are currently breastfeeding.
- You have a known HIV infection.
- You have a condition affecting how your body absorbs or processes medicines, including inflammatory bowel disease or having had gastric bypass surgery.
- You have a medical condition (other than liver disease) that can cause raised ALP levels, such as Paget's disease, OR a serious illness such as cancer (other than certain very mild, stable cancers) that is expected to reduce your life expectancy to less than 2 years.
- You have other significant medical conditions that are not well managed, or your other medications are expected to change during the trial.
- You have a history of drinking heavily (more than the equivalent of fourteen glasses of wine or fourteen cans of beer per week) or using other substances within the past year.
- You have taken part in another clinical drug, biologic, or medical device trial within the past 30 days.
- You have a history of not following medical treatment plans, or there are concerns that you may not be able to follow the trial reliably.
- You have donated blood or plasma within 30 days before the trial start date.
- You have a mental health condition that might affect your ability to give valid consent or follow the trial plan (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.
Contact this trial
Principal Investigator: Christian Weyer, MD, Intercept Pharmaceuticals, Inc.
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
DB Phase: Composite Endpoint Alkaline Phosphatase (ALP) And Total Bilirubin, 10 mg OCA Versus Placebo; LTSE Phase: Composite Endpoint ALP And Total Bilirubin
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.