Primary Biliary Cholangitis Trial, Completed NCT05292872 Sponsor: Intercept Pharmaceuticals Condition: Primary Biliary Cholangitis
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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 study looked at 4,577 people with a liver condition called primary biliary cholangitis (PBC). Of these, 403 were treated with a medicine called obeticholic acid (OCA), and 4,174 were treated with other approaches that did not include OCA. The study was observational — meaning it looked at real-world health records rather than randomly assigning people to treatments — and it tracked whether participants experienced serious liver-related events over time, including death from any cause, liver transplant, or hospital admission for certain liver complications. The reported data shows that, among the 403 OCA-treated participants, 8 experienced at least one of the serious events being tracked during the study period. Among the 4,174 non-OCA-treated participants, 32 such events were recorded. Breaking this down further: 2 deaths were recorded in the OCA group compared with 9 in the non-OCA group; 2 liver transplants occurred in the OCA group compared with 12 in the non-OCA group; and 6 hospitalisations for liver complications were recorded in the OCA group compared with 23 in the non-OCA group. It is important to note that the two groups were very different in size, so these raw numbers alone do not tell the full story — the study used a statistical method to try to make the groups more comparable before drawing conclusions, but the details of that analysis were not included in the figures submitted to the registry. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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.

Primary Biliary Cholangitis Trial, Completed

NCT05292872
Completed Not Applicable

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 a condition called Primary Biliary Cholangitis (PBC), either confirmed or strongly suspected
  • You have either not responded well enough to a medication called UDCA (ursodeoxycholic acid), or you were unable to tolerate it
  • You are 18 years old or older at the time you enter the study
  • You have at least 12 months of continuous medical records available before joining the study, with enough information to be evaluated

Who may not be able to join:

  • You have or have had another liver disease at the same time as your current condition
  • You have a history of any cancer other than non-melanoma skin cancer, or you have had melanoma
  • You have a history of HIV
  • You have a medical condition that could cause certain liver-related blood test results (ALP levels) to appear elevated for reasons unrelated to the liver (confirm with trial site)
  • Your recent blood test results suggest serious liver damage or significant liver injury
  • You have previously had a liver transplant
  • You are currently using or have used certain cholesterol-lowering medications called fenofibrate or bezafibrate
  • You have a history of, or currently have, serious complications related to liver failure (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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

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Trial details

Status
Completed
Phase
Not Applicable
Sponsor
Intercept Pharmaceuticals
Registry
ClinicalTrials.gov
Start date
1 June 2015
Est. completion
31 December 2021

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Risk of the First Event of the Composite Events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov