Phase 2 Primary Biliary Cholangitis Trial, Terminated NCT01142323 Sponsor: University of Miami 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 trial enrolled 8 participants, all of whom completed the study — none dropped out. The trial was looking at the effects of a medicine called fenofibrate in people with a liver condition called Primary Sclerosing Cholangitis (PSC). The main thing being measured was a substance in the blood called alkaline phosphatase (a marker that doctors use to monitor liver-related changes), checked at the start of the study and again after 6 months. A secondary measure was something called the Mayo Risk Score, a calculated number based on several factors (including age, certain blood results, and history of bleeding) that is used to estimate risk. The reported data shows that the average alkaline phosphatase level in blood was 290 U/L (units per litre) at the start of the study, and 165 U/L at the 6-month mark. These are the numbers as submitted — the trial did not report a statistical comparison between these two figures, so no further detail on that is available. For the Mayo Risk Score, the reported data shows two score values of -0.41 and -0.46 for the fenofibrate group, though the data as submitted does not clearly separate these into "start" and "end" timepoints — as such, a direct before-and-after comparison cannot be described with certainty from the information provided. A score below zero, as noted in the study description, is described as indicating low risk. 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.

Phase 2 Primary Biliary Cholangitis Trial, Terminated

NCT01142323
Terminated Phase 2

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 (male or female)
  • You have been diagnosed with Primary Sclerosing Cholangitis (PSC), confirmed by imaging tests showing narrowing and widening of the bile ducts in or outside the liver
  • Your blood test shows a liver enzyme called alkaline phosphatase at a level at least 1.5 times higher than the normal upper limit

Who may not be able to join:

  • You have had an allergic reaction to a medication called fenofibrate
  • You are currently in prison or living in an institution
  • You are pregnant or breastfeeding
  • Your doctors expect you will need a liver transplant within one year
  • You have already had a liver transplant
  • You have recurring bleeding from enlarged veins, uncontrolled confusion related to liver disease, or severe fluid build-up in the abdomen that cannot be managed (confirm with trial site)
  • You have another liver disease, such as autoimmune hepatitis or viral hepatitis
  • Your kidneys are not working well enough, based on a specific kidney function calculation (confirm with trial site)
  • You have a known inflammation of the gallbladder (gallstones-related condition)
  • You are currently taking cholesterol-lowering medications called statins
  • You are currently taking a blood-thinning medication called warfarin (Coumadin)
  • You have a personal history of, or are considered high risk for, blood clots in your veins

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
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Terminated
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 October 2010
Est. completion
1 December 2012

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Serum Alkaline Phosphatase

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

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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