A Global Multi-Center Prospective Observational Cohort to Support Drug Development in Adult Patients with Primary Sclerosing Cholangitis
C
Craig Lammert, MD
Primary Investigator
Enrolling By Invitation
18 years - 75 years
All
Phase
N/A
100 participants needed
1 Location
Brief description of study
What is the purpose of this study?
To 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. This is a 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.
THIS STUDY IS ENROLLING BY INVITATION ONLY
Detailed description of study
What will happen during the study?
- A standardized procedure for collection and processing of human blood will be applied to all blood samples collected as part of the study. Barcoded samples will be stored at the clinical centers, and corresponding data will be entered into the study database.
- Any protocol deviations should also be recorded by each center.
- 30mL of blood is collected at baseline and at each annual visit.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Primary Sclerosing Cholangitis, PSC
-
Age: 18 years - 75 years
-
Gender: All
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 based on current AASLD Guidelines (Bowlus 2023).
Exclusion Criteria:
- Clinically significant acute or chronic liver disease of an etiology other than PSC (with or without presence of features of AIH).
- Small-Duct PSC.
- Clinically diagnosed secondary or IgG4-related sclerosing cholangitis.
- Clinically diagnosed acute cholangitis and currently receiving treatment. Patients on chronic suppressive antibiotics will be allowed to enroll.
- 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)
- Prior liver transplantation
- MELD-Na Score >15. For subjects on anticoagulation medication, baseline INR determination for MELD score calculation should take this use into account.
- 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.
- 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 interventional clinical study.
- Absence of data in medical records to assess inclusion and exclusion criteria.
Updated on
13 Jan 2025.
Study ID: GI-PSC-WIND, 23462
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