Phase 3 Primary Biliary Cholangitis Trial, Not Yet Recruiting NCT06886360 Sponsor: Dr. Falk Pharma GmbH Condition: Primary Biliary Cholangitis
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Phase 3 Primary Biliary Cholangitis Trial, Not Yet Recruiting

NCT06886360
Not Yet Recruiting Phase 3

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 must be willing and able to sign a consent form agreeing to take part in the study.
  • You must be 18 years old or older (any gender).
  • You must have previously been diagnosed with PSC (Primary Sclerosing Cholangitis), have taken part in an earlier related trial called NUC-5/PSC, and either completed that trial's main treatment phase, or left it early — but only if you left early because the treatment did not work well enough for you (confirm with trial site for exact definition of "lack of efficacy").

Who may not be able to join:

  • You may not be able to join if you regularly drink a significant amount of alcohol — more than about 2–3 standard drinks per day for men, or more than about 1–2 standard drinks per day for women (confirm with trial site for exact thresholds).
  • You may not be able to join if you left the previous NUC-5/PSC trial early because of a side effect that may have been caused by the study drug.
  • You may not be able to join if you have liver cirrhosis (severe liver scarring) or any related complications that the trial doctor feels could put your health at risk.
  • You may not be able to join if you have previously had a liver transplant, or if you are currently on a waiting list for one.

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 3: approximately ~65% 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: Michael Trauner, MD, Medical University of Vienna, dept. of Internal Medicine III

Phone: +497611514 Ext. 0

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
Phase 3
Sponsor
Dr. Falk Pharma GmbH
Registry
ClinicalTrials.gov
Start date
1 March 2025
Est. completion
1 September 2027

Primary endpoints

Occurrence of treatment emergent adverse events; Occurrence of serious treatment emergent adverse events; Occurrence of severe treatment emergent adverse events; Occurrence of adverse drug reactions; Occurrence of unexpected treatment emergent adverse events; Occurrence of treatment emergent adverse events leading to study withdrawal; Occurrence of adverse events leading to death

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