RECRUITING

Global Prospective, Observational Cohort of Adult Patients with Primary Sclerosing Cholangitis (WIND-PSC Study)

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PSC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

A Global Multi-Center Prospective Observational Cohort to Support Drug Development in Adult Patients with Primary Sclerosing Cholangitis (WIND-PSC)

Quick Facts

Study Start:2024-05-06
Study Completion:2031-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06297993

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Confirmed clinical diagnosis of large duct PSC based on current AASLD Guidelines (Bowlus 2023).
  1. 1. Clinically significant acute or chronic liver disease of an etiology other than PSC (with or without presence of features of AIH).
  2. 2. Small-Duct PSC.
  3. 3. Clinically diagnosed secondary or IgG4-related sclerosing cholangitis.
  4. 4. Clinically diagnosed acute cholangitis and currently receiving treatment. Patients on chronic suppressive antibiotics will be allowed to enroll.
  5. 5. UDCA dose \>28 mg/kg
  6. 6. Evidence of current or historical decompensated cirrhosis based on the following clinical events:
  7. * Ascites \> Grade 2 and requiring treatment
  8. * Esophageal or gastric variceal bleeding requiring hospitalization
  9. * Hepatic encephalopathy (as defined by a West Haven score ≥ 2)
  10. * Spontaneous bacterial peritonitis defined as ascites absolute neutrophil count \>250/mm3 in the absence of an intra-abdominal source of infection
  11. * AKI-HRS according to AASLD Guidelines (Flamm 2021)
  12. 7. Prior liver transplantation
  13. 8. MELD-Na Score \>15. For subjects on anticoagulation medication, baseline INR determination for MELD score calculation should take this use into account.
  14. 9. 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 48 weeks.
  15. 10. Participants who are impaired, incapacitated, or incapable of completing study- related assessments or giving informed consent.
  16. 11. Prisoners or participants who are involuntarily incarcerated.
  17. 12. Participants who are currently participating in an interventional clinical study.
  18. 13. Absence of data in medical records to assess inclusion and exclusion criteria.

Contacts and Locations

Study Contact

Stephen Rossi, PharmD
CONTACT
3037715227
stephen@pscpartners.org
Priya Kannusamy
CONTACT
3037715227
priya@pscpartners.org

Principal Investigator

Cynthia Levy, MD
PRINCIPAL_INVESTIGATOR
University of Miami
Stephen Rossi, PharmD
PRINCIPAL_INVESTIGATOR
PSC Partners Seeking a Cure

Study Locations (Sites)

Schiff Center for Liver Diseases / University of Miami
Miami, Florida, 33136
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Virginia Commonwealth University
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: PSC Partners Seeking a Cure

  • Cynthia Levy, MD, PRINCIPAL_INVESTIGATOR, University of Miami
  • Stephen Rossi, PharmD, PRINCIPAL_INVESTIGATOR, PSC Partners Seeking a Cure

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-06
Study Completion Date2031-01

Study Record Updates

Study Start Date2024-05-06
Study Completion Date2031-01

Terms related to this study

Additional Relevant MeSH Terms

  • PSC