Investigating the Cholestatic Pruritus of Primary Sclerosing Cholangitis (ItCh-PSC): A study of patients participating in the Consortium for Autoimmune Liver Disease (CALiD)
Enrolling By Invitation
18 years - 100 years
All
Phase
N/A
1 participants needed
Brief description of study
What is the purpose of this study?
This is an observational study of patients with PSC to address knowledge gaps in the clinical presentation, natural history, epidemiology, patient experience and treatment of pruritus in PSC. Sub-study 1 is the retrospective component (collecting data from 1810808663). Sub-study 2 is visit one. Sub-study 3 consists of all of the visits after that initial visit.
THIS STUDY IS ENROLLING BY INVITATION ONLY - The retrospective data collection part of this study (sub-study 1), will have no subject interaction. For sub-studies 2 and 3, participants will be recruited during their clinic visits by the research team.
Detailed description of study
To understand the incidence, frequency, severity, and persistence of pruritus in patients with PSC. Characterize the natural history of pruritus amongst PSC patients with pruritus.
• Participants who report a worst itch in the past 24 hours, 7 days, or 6 months on the NRS of > 4 at Month 0 will be asked to continue in a prospective follow up period of 6 months. Eligible participants may start the prospective follow up at any time following the month 0 visit.
• Participation in an interventional clinical trial at any time during the prospective follow up is exclusionary.
• Participation in an interventional clinical trial at any time during the prospective follow up is exclusionary.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Primary Sclerosing Cholangitis, PSC
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Age: 18 years - 100 years
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Gender: All
Inclusion criteria
o PSC - Diagnosed according to accepted criteria, including cholangiography compatible with PSC or
o Small duct PSC – Liver histology typical/compatible with PSC, but normal cholangiogram. If no IBD: histology typical of PSC. If IBD is present, then histology at least compatible with PSC or
o PSC with features of AIH (PSC/AIH overlap) - PSC in combination with biochemical, serological and histological features overlapping with AIH
Exclusion criteria
• Presence of other concomitant liver diseases including viral hepatitis, primary biliary cholangitis, alcoholic liver disease, Wilson’s disease, or hemochromatosis.
• Death or liver transplantation prior to January 1, 2008.
• Absence of data in medical record after January 1, 2008.
Additional Inclusion/Exclusion Criteria for prospective study
• Participants who meet the inclusion/exclusion criteria for the main study (Section 9.2) and have not had a liver transplant will be eligible for Sub-Study 2 and 3.
o PSC - Diagnosed according to accepted criteria, including cholangiography compatible with PSC or
o Small duct PSC – Liver histology typical/compatible with PSC, but normal cholangiogram. If no IBD: histology typical of PSC. If IBD is present, then histology at least compatible with PSC or
o PSC with features of AIH (PSC/AIH overlap) - PSC in combination with biochemical, serological and histological features overlapping with AIH
Exclusion criteria
• Presence of other concomitant liver diseases including viral hepatitis, primary biliary cholangitis, alcoholic liver disease, Wilson’s disease, or hemochromatosis.
• Death or liver transplantation prior to January 1, 2008.
• Absence of data in medical record after January 1, 2008.
Additional Inclusion/Exclusion Criteria for prospective study
• Participants who meet the inclusion/exclusion criteria for the main study (Section 9.2) and have not had a liver transplant will be eligible for Sub-Study 2 and 3.
Updated on
01 Apr 2025.
Study ID: GI-UC-CALID, 13293
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