Phase 2 Primary Biliary Cholangitis Trial, Recruiting NCT05835505 Sponsor: Brigham and Women's Hospital Condition: Primary Biliary Cholangitis
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Phase 2 Primary Biliary Cholangitis Trial, Recruiting

NCT05835505
Recruiting 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 Sclerosing Cholangitis (PSC) for at least 6 months, confirmed by a specific type of imaging scan of your bile ducts (confirm with trial site)
  • A liver enzyme called ALP (alkaline phosphatase) in your blood is higher than 1.5 times the normal range at the time of screening
  • You are either taking a stable dose of a medication called ursodeoxycholic acid (UDCA) for more than 6 months before screening, or you stopped taking it more than 4 weeks before screening

Who may not be able to join:

  • Your doctors expect you may need a liver transplant within the next year, based on a specific liver health scoring system
  • You have signs of serious liver disease, such as bleeding from enlarged veins, fluid build-up in the abdomen, or confusion caused by liver problems
  • Your liver disease is considered advanced, based on certain blood test results (confirm with trial site for specific values)
  • You have another ongoing liver condition at the same time, such as alcohol-related liver disease, hepatitis B or C, or several other named liver conditions
  • Your bile duct disease is caused by something other than PSC
  • You have been diagnosed with cancer in the last 5 years (except certain common skin cancers)
  • You have taken part in another clinical trial or used an experimental treatment within the past 2 months (or longer, depending on the treatment)
  • You currently use illegal drugs or drink more than a moderate amount of alcohol
  • You had a bile duct infection within the last 6 months before joining
  • You have Ulcerative Colitis or Crohn's disease that requires additional treatment at the time of screening
  • You have reduced kidney function, based on a specific blood test result (confirm with trial site)
  • You are currently pregnant or breastfeeding
  • You have high blood pressure that is not well controlled (confirm with trial site for specific values)
  • You are currently taking vitamin C or prednisone
  • You have a history of or are at risk for heart-related conditions, including irregular heartbeat, heart failure, stroke, or coronary artery disease
  • You have a history of kidney stones
  • You have a condition that weakens your immune system, whether you were born with it or developed it
  • You have diabetes or lupus
  • You have had a sudden bile duct infection within 4 weeks of your screening appointment

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.

Contact this trial

Principal Investigator: Joshua A Korzenik, MD, Brigham and Womens Hospital

Phone: 5089363674

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
12 December 2023
Est. completion
1 May 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Alkaline Phosphatase (ALP) Test Result

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