Phase 4 Primary Biliary Cholangitis Trial, Completed NCT02078882 Sponsor: Christopher Bowlus, MD 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 16 participants, all of whom received weekly injections of a medicine called abatacept (125 mg). All 16 participants completed the study — none dropped out. The trial was looking at a condition affecting the liver called primary biliary cholangitis, and the main thing researchers were measuring was whether a particular liver enzyme called alkaline phosphatase (a substance in the blood that can signal liver stress) dropped by more than 40% after 24 weeks of treatment. The reported data shows that only 1 out of the 16 participants met that main target — meaning their alkaline phosphatase level fell by more than 40% from where it started. On average across all participants, the alkaline phosphatase level changed by minus 2.8 units (IU/L) over 24 weeks, which the data presents as a very small decrease. Another liver enzyme called ALT showed an average change of plus 0.5 units (IU/L) — essentially little change. A scan-based measure of liver stiffness (how firm the liver tissue is, measured using a special type of MRI) showed an average change of minus 0.1 kPa, again a very small shift. A quality-of-life questionnaire designed specifically for this liver condition showed an average change of zero — meaning no overall change was recorded in participants' reported quality of life. Regarding safety, the reported data shows that 4 out of 16 participants experienced some form of adverse event (an unwanted or unexpected health occurrence) during the study, though further detail on the nature of those events was not included in the submitted 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 4 Primary Biliary Cholangitis Trial, Completed

NCT02078882
Completed Phase 4

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 Cholangitis (PBC), confirmed by at least 2 of the following 3 things: a specific blood test result (AMA titer above 1:40), a liver enzyme called alkaline phosphatase that has been higher than normal for at least 6 months, or a liver biopsy showing signs of PBC
  • You have been taking a medication called UDCA (ursodeoxycholic acid) for at least 6 months at an adequate dose, but your alkaline phosphatase level is still higher than the target range, suggesting the medication has not fully worked
  • You have been on a stable, unchanged dose of UDCA for at least 3 months before the start of the trial
  • Two other liver-related blood test results (AST and ALT) are not more than 5 times above the normal range

Who may not be able to join:

  • You have another liver condition at the same time, such as viral hepatitis, a bile duct disease called primary sclerosing cholangitis, alcohol-related liver disease, Wilson's disease, hemochromatosis, or Gilbert's syndrome
  • You have previously had a liver transplant
  • Your liver disease has reached an advanced or "decompensated" stage (confirm with trial site)
  • You have used medications that suppress the immune system within the last 6 months before the trial start date
  • You have used a type of medication called "biologic agents" within the last 12 months before the trial start date (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
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

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Trial details

Status
Completed
Phase
Phase 4
Sponsor
Christopher Bowlus, MD
Registry
ClinicalTrials.gov
Start date
1 September 2014
Est. completion
1 October 2018

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Biochemical Response

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