Primary Biliary Cholangitis Trial, Recruiting NCT04181138 Sponsor: Arbor Research Collaborative for Health Condition: Primary Biliary Cholangitis
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Primary Biliary Cholangitis Trial, Recruiting

NCT04181138
Recruiting Not Applicable

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 2 and 25 years old at the time of screening.
  • You have been diagnosed with large duct PSC (a liver/bile duct condition), confirmed by a special imaging scan of the bile ducts showing certain abnormal patterns.
  • You have been diagnosed with small duct PSC, confirmed by a liver tissue sample (biopsy) showing specific signs of the disease.
  • You are willing and able to follow all study procedures and remain available for the full length of the study.
  • You (and/or your parent or guardian) are able to give informed consent to participate.
  • For the imaging part of the study only: you are between 8 and 25 years old, have no reason you cannot have an MRI scan, and have no skin condition that could be made worse by a type of MRI-related procedure (confirm with trial site).

Who may not be able to join:

  • You have previously had a liver transplant.
  • You have previously had a bone marrow transplant.
  • You have a condition that seriously weakens your immune system (such as certain rare immune disorders or HIV/AIDS) that could cause a different type of bile duct disease.
  • You have a history of certain rare diseases affecting immune cells, such as Langerhans cell histiocytosis or hemophagocytic lymphohistiocytosis (confirm with trial site).
  • You have had bile duct damage caused by a lack of blood flow (ischemic cholangitis).
  • You have a history of blood clots in the portal vein affecting the bile ducts, a liver vein-blocking condition, or bile duct damage from abdominal radiation.
  • You have a history of repeated serious bile duct infections (recurrent pyogenic cholangitis).
  • You have had bile duct surgery for gallstones before the scan or biopsy used to determine your eligibility.
  • You have had bile duct surgery for a cyst in the bile duct (choledochal cyst).
  • You have a history of liver cancer (hepatocellular carcinoma or hepatoblastoma).
  • You have had a bile duct injury during surgery.
  • You were born with a CMV (cytomegalovirus) liver infection.
  • You have Sickle Cell Disease.
  • You have cystic fibrosis, biliary atresia, Caroli disease, congenital hepatic fibrosis, or a specific inherited bile duct disorder called MDR3 disease.
  • You have liver damage caused by heart problems (cardiac hepatopathy).
  • You have certain metabolic (body chemistry) disorders, including Wilson's disease, glycogen storage disorder, or Alpha-1 Antitrypsin deficiency.
  • You have been diagnosed with systemic lupus erythematosus (SLE), an autoimmune disease.
  • You are currently pregnant at the time of enrollment.

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
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Cara Mack, MD, Medical College of Wisconsin-Milwaukee

Phone: 734-693--3811

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
Not Applicable
Sponsor
Arbor Research Collaborative for Health
Registry
ClinicalTrials.gov
Start date
30 December 2021
Est. completion
31 May 2029

Where this trial is recruiting

🇨🇦 Canada 🇺🇸 United States

Primary endpoints

To characterize the major phenotypes of PSC including patients with large duct or small duct disease, with and without Inflammatory Bowel Disease (IBD), and with and without Auto Immune Hepatitis (AIH)

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