NCT06297993 · PSC Partners Seeking a Cure
Global Prospective, Observational Cohort of Adult Patients With Primary Sclerosing Cholangitis (WIND-PSC Study)
(WIND-PSC)
What this study is about
Develop an appropriate real-world data comparator group of participants to support the design, execution, and serve as an external control for interventional clinical trials in PSC.
View original scientific description
Develop an appropriate real-world data comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult patients between 18 and 75 years of age (inclusive) who can comprehend instructions, follow the study procedures and are willing to sign an Informed Consent Form (ICF).
- Confirmed clinical diagnosis of large duct PSC.
Exclusion criteria
- Clinically significant acute or chronic liver disease of an etiology other than PSC (including but not limited to metabolic-dysfunction associated steatohepatitis (MASH), PBC, HCV, HBV, or alcoholic hepatitis, Wilson's disease, alpha-1 antitryp-sin deficiency, acute or chronic drug-induced liver injury)
- Patients with PSC and elements of AIH overlap are allowed to enroll
- Patients with metabolic dysfunction associated steatotic liver disease (MASLD) or benign steatosis are allowed to enroll
- Small-Duct PSC.
- Clinically diagnosed secondary or IgG4-related sclerosing cholangitis.
- Clinically diagnosed infections (including acute cholangitis) and receiving treatment within the past 7 days; patients on chronic suppressive antibiotics for acute cholangitis will be allowed to enroll
- Hospitalization in the past 7 days
- UDCA dose \>28 mg/kg
- Evidence of current or historical decompensated cirrhosis based on the following clinical events:
- Ascites \> Grade 2 and requiring treatment
- Esophageal or gastric variceal bleeding requiring hospitalization
- Hepatic encephalopathy (as defined by a West Haven score ≥ 2)
- Spontaneous bacterial peritonitis defined as ascites absolute neutrophil count \>250/mm3 in the absence of an intra-abdominal source of infection
- AKI-HRS according to AASLD Guidelines (Flamm 2021)
- Portal hypertension based on a platelet count \< 150 × 109/L and LSM \> 15 kPa with clinical, laboratory, imaging and/or other relevant parameters
- Prior liver transplantation
- MELD 3.0 Score \>15. For subjects on anticoagulation medication, baseline INR determination for MELD score calculation should take this use into account.
- History, evidence, or high suspicion of hepatobiliary malignancies or active colon cancer based on imaging, screening laboratory values, and/or clinical symptoms. Patients with a history of colon cancer who have undergone a colectomy and have no current evidence of colon cancer will be allowed to enroll in the study.
- Participants with current clinical or laboratory evidence of any severe, progressive, or uncontrolled disease, related or unrelated to PSC and which, in the opinion of the investigator, has an expected survival of less than 52 weeks.
- Participants who are impaired, incapacitated, or incapable of completing study-related assessments or giving informed consent.
- Prisoners or participants who are involuntarily incarcerated.
- Participants who are currently participating in an investigational PSC therapy clinical study or who have participated in such a study within the past 12 weeks
- Absence of data in medical records to assess inclusion and exclusion criteria.
Where
- Sacramento, California
- San Francisco, California
- New Haven, Connecticut
- Miami, Florida
- Indianapolis, Indiana
- Boston, Massachusetts
- Rochester, Minnesota
- Dallas, Texas
- Richmond, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations