Phase 1 Primary Biliary Cholangitis Trial, Recruiting NCT06455280 Sponsor: Elizabeth C. Verna Condition: Primary Biliary Cholangitis
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Phase 1 Primary Biliary Cholangitis Trial, Recruiting

NCT06455280
Recruiting Phase 1

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 able to give your own consent to participate in the study
  • You are 18 years old or older
  • You have been diagnosed with autoimmune hepatitis (AIH) and/or primary sclerosing cholangitis (PSC), which are liver conditions caused by the immune system
  • You are already on the waiting list to receive a liver transplant
  • A blood test taken within the past 12 months shows you have been previously exposed to the Epstein-Barr virus (the virus that causes glandular fever)

Who may not be able to join:

  • You have, or have had, a significant liver disease other than AIH or PSC, such as hepatitis caused by a virus, liver disease from alcohol, or a type of liver disease related to fat buildup confirmed by a biopsy
  • You have previously had an organ transplant
  • You are waiting for more than one organ to be transplanted at the same time
  • You are experiencing sudden, severe liver failure
  • You have been diagnosed with any cancer, including certain types related to the liver or bile ducts
  • You have taken part in another clinical drug trial in the last 30 days, or within a timeframe based on how long the last trial drug stays in your body (confirm with trial site)
  • You are pregnant, breastfeeding, or not willing to use contraception during the study
  • Your white blood cell count is very low (confirm with trial site)
  • Your lymphocyte count (a type of white blood cell) is very low (confirm with trial site)
  • You have tested positive for HIV-1
  • You have tested positive for hepatitis C within the past 6 months
  • You have tested positive for hepatitis B within the past 6 months
  • Your alcohol use is above a certain daily limit set for men and women, or a recent blood marker for alcohol use is above a certain level (confirm with trial site)
  • You have an untreated latent (inactive) tuberculosis infection, as detected by a specific blood test
  • You have received a live vaccine within 2 months of your transplant date

Additional reasons you may not be able to join at the time of your transplant:

  • Your kidneys are not working well enough at the time of transplant, either requiring dialysis or showing a low kidney function score (confirm with trial site)
  • Your liver disease severity score is above 30 on a specific medical scale used for transplant waiting lists (confirm with trial site)
  • The donor liver comes from certain donation types, carries certain infections, or is not a compatible blood type with yours (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 1: approximately ~10% 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: Elizabeth Verna, MD, Columbia University Irving Medical Center/ New York Presbyterian Hospital

Phone: 212-305-3839

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 1
Sponsor
Elizabeth C. Verna
Registry
ClinicalTrials.gov
Start date
11 September 2024
Est. completion
31 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Serious infection in the first month post-transplant,

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