PSCWIND-PSCNCT06297993
Global Prospective, Observational Cohort of Adult Patients With Primary Sclerosing Cholangitis (WIND-PSC Study)
An observational study of PSC, run by PSC Partners Seeking a Cure at 18 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- PSC
- How many people
- 2,000 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 6 May 2024to Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 2000 adult participants with confirmed diagnosis of large duct PSC
Who may be able to join
- 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.
Who cannot join
- 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
Show all 23Show fewer
- 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.
Trial locations and contacts
18 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
Zuha Jeddy, MPH contact
18 sites in 6 countries
United States11 sites, 10 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Gary Zhang, gzhang18@mgb.org
Daniel Pratt, MD
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Julie Shea, 617-632-1129, jmshea@bidmc.harvard.edu
Vilas Patwardhan, MD
- Withdrawn
UT Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Rebecca Gerstorff, rebgerst@iu.edu
Craig Lammert, MD
- Recruiting
Schiff Center for Liver Diseases / University of Miami
Miami, Florida, 33136
Cynthia Levy, MD, 306.243.4615, clevy@med.miami.edu
Cynthia Levy, MD
- Recruiting
Yale University
New Haven, Connecticut, 06510
Marina Silveira
Marina Silveira, MD
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Caitlin Hurst, BS, (804) 828-9405, caitlin.hurst@vcuhealth.org
Obi Aseem, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55901
Paige Powrie, Powrie.Paige@mayo.edu
John Eaton, MD
- Recruiting
UC Davis
Sacramento, California, 95817
Samrrah Raouf, saraouf@health.ucdavis.edu
Christopher Bowlus, MD
- Recruiting
California Pacific Medical Center
San Francisco, California, 94109
Stefanie Roberts, BS, 415-600-1107, stefanie.roberts@sutterhealth.org
Kidist Yimam, MD
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Fawzy Barry, fawzy.barry@ucsf.edu
Michael Li, MD, MPH
Canada3 sites, 3 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2X8
Rebecca Miller, rebecca.gildr@ualberta.ca
Aldo Montano-Loza, MD, MSc, PhD, FAASLD, FACG
- Recruiting
Centre de recherche du centre hospitalier de l'Université de Montréal (CRCHUM)
Montreal, Quebec, H2X 0A9
Anik Desormeaux, anik.desormeaux.chum@ssss.gouv.qc.ca
Julian Hercun, MD
- Recruiting
University Health Network
Toronto, Ontario, M5G2C4
Claire Gage, 647-984-8146, claire.gage@uhn.ca
Gideon Hirschfield, FRCP,MD
Germany1 site, 1 recruiting
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg, Free and Hanseatic City of Hamburg, 20246
Jan-Philipp Weltzsch, MD, 4915222816718, j.weltzsch@uke.de
Christoph Schramm, Prof. Dr.
Italy1 site, 1 recruiting
- Recruiting
University of Milano Bicocca
Milan, Monza (MB), 20900
Sarah Amato, sarah.amato@irccs-sangerardo.it
Laura Cristoferi, MD, PhD
New Zealand1 site, 1 recruiting
- Recruiting
Auckland University
Auckland
Yuliya Evdokimova, yuliya@adhb.govt.nz
Hannah Giles, MBChB, FRACP
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford University Hospitals
Oxford, OX3 9DU
Loren Smith, 01865 221575, Loren.Smith@ouh.nhs.uk
Emma Culver, BSc (Hons), MBChB, MRCP, DPhil
About this study
Official title: A Global Multi-Center Prospective Observational Cohort to Support Drug Development in Adult Patients With Primary Sclerosing Cholangitis (WIND-PSC)
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.
Read the detailed description
Global, multi-center longitudinal observational cohort study. Collection of prospective clinical data to include liver-related clinical outcomes and safety events, hepatobiliary malignancies, relevant key biomarkers, imaging assessments, PSC-related clinical symptoms, patient-reported outcomes, and medication use in adult patients with PSC.
- Conditions
- PSC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with a confirmed diagnosis of large duct PSC. | 1. 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). 2. Confirmed clinical diagnosis of large duct PSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Develop an appropriate real-world data (RWD) comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC.
Collection of liver-related data including PSC symptoms, medical history, adverse events, and outcomes at enrollment and each quarterly and annual visit.
Measured: Quarterly for five years from enrollment
Secondary outcomes (3)
Develop a large clinical and biomarker data set to identify individual and/or composite surrogate end-points likely to predict clinical benefit for use in the design of interventional studies in PSC.
Collection of biomarkers at enrollment and each annual visit.
Measured: Quarterly for five years from enrollment
Develop a large clinical and biomarker data set to identify individual and/or composite surrogate end-points likely to predict clinical benefit for use in the design of interventional studies in PSC.
Collection of imaging at enrollment and each annual visit.
Measured: Quarterly for five years from enrollment
Evaluate direct participant experiences with standardized tools to determine changes over time, the association with clinical events, biomarkers, and disease progression
Patient Reported Outcomes surveys will be collected from all participants at enrollment and each quarterly and annual visit.
Measured: Quarterly for five years from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start6 May 2024
- Primary completionJan 2029 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PSCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PSC Partners Seeking a Cure
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia Levy, MD, Principal investigator, University of MiamiStephen Rossi, PharmD, Principal investigator, PSC Partners Seeking a Cure
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297993
- Sponsor's protocol ID
- WIND-PSC-01
- Acronym
- WIND-PSC
- Status last verified
- Sep 2026
- First submitted
- 29 Jan 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Global Multi-Center Prospective Observational Cohort to Support Drug Development in Adult Patients With Primary Sclerosing Cholangitis (WIND-PSC)
- ClinicalTrials.gov ID
- NCT06297993
- Acronym / sponsor ID
- WIND-PSC / WIND-PSC-01
- Conditions
- PSC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- PSC Partners Seeking a CureUniversity, hospital or other
- Study start
- 6 May 2024 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Global, multi-center longitudinal observational cohort study. Collection of prospective clinical data to include liver-related clinical outcomes and safety events, hepatobiliary malignancies, relevant key biomarkers, imaging assessments, PSC-related clinical symptoms, patient-reported outcomes, and medication use in adult patients with PSC.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with a confirmed diagnosis of large duct PSC. | – | –1. 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). 2. Confirmed clinical diagnosis of large duct PSC |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 2000 adult participants with confirmed diagnosis of large duct PSC
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (23 listed)
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Develop an appropriate real-world data (RWD) comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC.
Time frame: Quarterly for five years from enrollment
Collection of liver-related data including PSC symptoms, medical history, adverse events, and outcomes at enrollment and each quarterly and annual visit.
3 secondary outcomes
Develop a large clinical and biomarker data set to identify individual and/or composite surrogate end-points likely to predict clinical benefit for use in the design of interventional studies in PSC.
Time frame: Quarterly for five years from enrollment
Develop a large clinical and biomarker data set to identify individual and/or composite surrogate end-points likely to predict clinical benefit for use in the design of interventional studies in PSC.
Time frame: Quarterly for five years from enrollment
Evaluate direct participant experiences with standardized tools to determine changes over time, the association with clinical events, biomarkers, and disease progression
Time frame: Quarterly for five years from enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zuha Jeddy, MPH contact
Cynthia Levy, MD principal investigator
University of Miami
Stephen Rossi, PharmD principal investigator
PSC Partners Seeking a Cure
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PSC, run by PSC Partners Seeking a Cure at 18 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Canada, Germany, Italy, New Zealand and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephen Rossi, PharmD (3037715227, stephen@pscpartners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Develop an appropriate real-world data (RWD) comparator cohort to support the design, execution, and serve as an external control for interventional clinical trials in PSC. (time frame: Quarterly for five years from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.