Adult Patients With Primary Sclerosing Cholangitis

PSC Clinical Trial

— WIND-PSC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06297993
• Other study ID #: WIND-PSC-01
• Status: Recruiting
• Start date: May 6, 2024
• Est. completion date: January 2031

Study information

• Verified date: May 2024
• Source: Arbor Research Collaborative for Health
• Contact: Melissa Sexton
• Phone: 7346654108
• Email: melissa.sexton[@]arborresearch.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 2031
• Est. primary completion date: January 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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 based on current AASLD Guidelines (Bowlus 2023).

Exclusion Criteria:

1. Clinically significant acute or chronic liver disease of an etiology other than PSC (with or without presence of features of AIH).

2. Small-Duct PSC.

3. Clinically diagnosed secondary or IgG4-related sclerosing cholangitis.

4. Clinically diagnosed acute cholangitis and currently receiving treatment. Patients on chronic suppressive antibiotics will be allowed to enroll.

5. UDCA dose >28 mg/kg

6. 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)

7. Prior liver transplantation

8. MELD-Na Score >15. For subjects on anticoagulation medication, baseline INR determination for MELD score calculation should take this use into account.

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.

10. Participants who are impaired, incapacitated, or incapable of completing study- related assessments or giving informed consent.

11. Prisoners or participants who are involuntarily incarcerated.

12. Participants who are currently participating in an interventional clinical study.

13. Absence of data in medical records to assess inclusion and exclusion criteria.

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• PSC

Locations

Country	Name	City	State
United States	Schiff Center for Liver Diseases / University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Arbor Research Collaborative for Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Develop interventional clinical trial external control using clinical and biomarker data.	Collection of liver-related data at enrollment and each quarterly and annual visit.	Quarterly for five years from enrollment
Secondary	Identify alternative endpoints to predict clinical benefit using large clinical and biomarker data.	Collection of biomarker and imaging at enrollment and each annual visit.	Quarterly for five years from enrollment
Secondary	Changes in patient reported outcomes over time as assessed by Patient Reported Outcomes surveys.	Patient Reported Outcomes surveys will be collected from all participants at enrollment and each quarterly and annual visit.	Quarterly for five years from enrollment