Phase 2 Primary Biliary Cholangitis Trial, Completed NCT00575042 Sponsor: University of Florida Condition: Primary Biliary Cholangitis
Back to Primary Biliary Cholangitis

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 20 people who were given fenofibrate (160 mg per day). It was a single-group study, meaning all participants received the same treatment — there was no comparison group receiving a different treatment or a dummy pill. The trial was measuring levels of a substance in the blood called alkaline phosphatase (ALP), which is an enzyme that can be elevated in certain liver and bone conditions. Of the 20 people who started the trial, 17 completed it and 3 did not finish. The reported data shows that the main thing being measured was the middle (or "median") ALP level in the blood — before and after one year of taking fenofibrate. Before treatment, the reported median ALP level was 351 U/L (units per litre, a standard way of measuring this enzyme in blood). After one year of treatment, the reported median ALP level was 175 U/L. No other outcome measures appear to have been submitted to ClinicalTrials.gov for this trial, so no further figures are available to report. It is important to note that these are numbers from a small group of 20 people, and the data as submitted does not include a separate untreated comparison group. No secondary outcome data was reported in the structured results available. 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, Completed

NCT00575042
Completed 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 have been diagnosed with Primary Biliary Cirrhosis (PBC), confirmed by a blood test (positive antimitochondrial antibodies) and/or a liver biopsy
  • You have previously been treated with a medication called UDCA at a dose of 13–15 mg/kg per day for at least 1 year
  • Your blood tests still show a certain liver enzyme (alkaline phosphatase) at twice or more above the normal range, confirmed on two separate blood tests
  • If you are a woman who could become pregnant, you must have a negative pregnancy test before starting the trial and agree to use adequate contraception throughout the study
  • You are willing to sign an informed consent form after reviewing the study details with a researcher

Who may not be able to join:

  • You have had an allergic reaction or sensitivity to a medication called fenofibrate
  • You are currently in prison or living in an institution
  • You are pregnant or currently breastfeeding
  • Based on a specific medical scoring system (the Mayo risk score), doctors expect you may need a liver transplant within one year
  • You have already received a liver transplant
  • You have recurring serious bleeding from swollen veins, uncontrolled confusion related to liver disease, or fluid buildup in your abdomen that cannot be managed
  • You have another liver condition at the same time, such as hepatitis, alcoholic liver disease, or certain other liver-related diseases (confirm with trial site)
  • You have acute or chronic kidney failure
  • You have a known history of gallbladder inflammation (cholecystitis) and still have your gallbladder
  • You are currently taking cholesterol-lowering medications called statins

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
Completed
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 August 2007
Est. completion
1 August 2009

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Serum Level of 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