Primary Biliary Cholangitis Trial, Not Yet Recruiting NCT07122206 Sponsor: Methodist Health System Condition: Primary Biliary Cholangitis
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Primary Biliary Cholangitis Trial, Not Yet Recruiting

NCT07122206
Not Yet 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 have been officially diagnosed with Primary Biliary Cholangitis (PBC), a liver condition.
  • You are 18 years of age or older.
  • You are currently taking a medication called ursodiol (also known as ursodeoxycholic acid) for PBC, or you cannot tolerate this medication due to side effects and have an elevated liver enzyme level (ALP) above the normal range.
  • You are currently being treated with a medication called seladelpar for PBC.
  • You are willing and able to sign a consent form agreeing to take part in the study.

Who may not be able to join:

  • You have another ongoing liver disease, such as hepatitis B, hepatitis C, a liver condition related to fat buildup (NASH), liver disease caused by alcohol use, or another autoimmune liver disease.
  • You have previously had a liver transplant.
  • You currently have cirrhosis (severe liver scarring) or signs that your liver is no longer working properly (confirm with trial site).
  • You have serious other health conditions, such as severe heart, kidney, or lung disease, that could affect the study results.
  • You are currently pregnant or breastfeeding.
  • You are unwilling or unable to follow the study plan, including attending scheduled appointments and completing required tests and procedures.

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: Mangesh Pagadala, MD, Methodist Heath System

Phone: 7373332427

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
Not Yet Recruiting
Phase
Not Applicable
Sponsor
Methodist Health System
Registry
ClinicalTrials.gov
Start date
1 August 2025
Est. completion
1 August 2027

Primary endpoints

ALP and bilirubin 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