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 enrolled 62 participants, all of whom received a combination of two medicines: obeticholic acid (OCA) at 5 mg and bezafibrate (BZF) at 400 mg. The trial was measuring safety-related information — specifically, how many participants experienced unwanted medical events (called adverse events) while taking the combination, including any serious events or events that caused someone to stop taking the medicines. It is noted that none of the 62 participants were recorded as having "completed" the study, with all 62 listed under "not completed," which may reflect the trial ending early; no further explanation for this was provided in the reported data. The reported data shows that out of 62 participants, 29 experienced at least one treatment-emergent adverse event (that is, a new or worsening medical event that occurred after starting the medicines). Of those, 3 experienced a serious adverse event — meaning an event considered medically significant, such as one requiring hospitalisation — and 1 person stopped taking the medicines due to an adverse event. One participant experienced a severe adverse event, described as one causing an inability to carry out usual daily activities. No deaths were reported during the study. The reported data also shows changes in some blood test measurements (such as blood cell counts and chemical markers in the blood) from the start of the study to later time points, with varying numbers of participants showing notable shifts in individual measurements; however, the specific blood parameters linked to each number were not able to be individually matched from the data as submitted. The reported data shows no deaths among the 62 participants across any cause. For the blood test findings, some markers showed no notable changes while others were flagged for a small number of participants, but the full context and clinical meaning of those individual figures were not detailed in the submitted results. 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 3 Primary Biliary Cholangitis Trial, Terminated
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 must have a condition called PBC (Primary Biliary Cholangitis) and must currently be taking the study medication as part of a previous related trial called Study 747-213 or Study 747-214.
Who may not be able to join:
- You have, or have had, other liver diseases alongside your PBC.
- You have developed serious complications directly related to your PBC.
- You have had, or currently have, a condition where your liver has stopped working properly (sometimes called liver decompensation) (confirm with trial site).
- You have, or have had, problems with your gallbladder.
- If you are female: you are pregnant, have a positive pregnancy test, or are currently breastfeeding.
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: Lynda Szczech, PhD, 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
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Leading to Discontinuation; Number of Participants Reporting Severe TEAEs
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.