Phase 2 Primary Biliary Cholangitis Trial, Completed NCT01249092 Sponsor: The Cleveland Clinic 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 enrolled 20 people, all of whom received a daily dose of a medication called pentoxifylline (400 mg per day). The trial was looking at people with a liver condition called primary biliary cirrhosis (PBC). Of the 20 who started, 18 completed the study, and 2 did not finish. The main thing being measured was a change in a blood marker called alkaline phosphatase — a substance measured in blood that can be linked to liver activity — after six months of treatment. The study also tracked a second blood marker called TIMP-1, which is associated with scarring (fibrosis) in the liver, as well as whether any serious unwanted health events occurred during the trial. The reported data shows that, on average, alkaline phosphatase levels changed by minus 57.3 U/L (units per litre) from the start of the study to the six-month mark, meaning the measured levels were lower at the end than at the beginning. For the secondary marker TIMP-1, the reported data shows an average change of minus 5.69 ng/mL (nanograms per millilitre), again indicating the measured levels were lower at the end of the study period. The reported data also shows that zero participants experienced a severe adverse (unwanted) health event during the study. No other figures beyond these averages were reported in the structured results data. 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

NCT01249092
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 are between 18 and 76 years old (male or female).
  • You have been diagnosed with Primary Biliary Cholangitis (PBC), confirmed by at least three of the following: a positive blood test for certain antibodies (AMA), abnormal liver-related blood test results, a liver biopsy consistent with PBC, or having ruled out other liver diseases.
  • You have been taking a medication called UDCA at the right dose for at least six months, but your liver blood test results (specifically alkaline phosphatase) have not returned to normal and are still at least 1.5 times higher than they should be.
  • You have no history of serious liver complications such as bleeding from swollen veins, confusion caused by liver problems, or severe fluid build-up in the abdomen.

Who may not be able to join:

  • You have signs that your liver disease may be caused by something other than PBC.
  • Your test results suggest you may have a combination of PBC and another liver condition called autoimmune hepatitis (confirm with trial site).
  • You have taken steroids, immune-suppressing, or immune-modifying medications in the past 6 months.
  • You have signs or test results suggesting your liver has already suffered serious, advanced damage (decompensated cirrhosis).
  • You are allergic or sensitive to the study drug (PTX) or related substances found in caffeine, theophylline, or theobromine.
  • You have a history of bleeding in your brain or eyes.
  • You have another serious health condition (such as heart disease, kidney disease, or cancer) that could interfere with taking part in the study.
  • You currently take certain blood-thinning or lung medications, specifically Theophylline, Coumadin (warfarin), or low molecular weight heparin, due to possible interactions with the study drug.
  • You are currently pregnant or 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.

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 November 2010
Est. completion
1 June 2012

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Serum Alkaline Phosphatase Levels.

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