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NCT05463445 Clinical Trial

Multicenter Observational Study of PSC and IgG4-SC in China

Primary Sclerosing Cholangitis Clinical Trial

Official title:
Multicenter Study of Clinical Characteristics and Management of Primary Sclerosing Cholangitis and IgG4-related Sclerosing Cholangitis in China.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05463445
Other study ID # SC2022CH001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date July 31, 2023

Study information
Verified date July 2022
Source RenJi Hospital
Contact Min Lian, MD, PhD
Phone +8615800744783
Email sophialian24@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators aimed to collect demographic features and clinical outcomes in patients diagnosed with PSC and IgG4-SC by utilizing participants database from multiple medical centers across Mainland China. Cross-sectional studies will focus on characterizing clinical presentations and validating diagnostic and prognostic models on Chinese PSC and IgG4-SC patients.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date July 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Age above 18 years old, - Male or Female, - Patients admitted in our medical centers which met the PSC criteria according to The European Association for the Study of the Liver Clinical Practice Guidelines "Management of cholestatic liver diseases" in 2009; or patients diagnosed with IgG4-SC which met initially using the Japan Pancreas Society criteria and confirmed using HISORt criteria. Exclusion Criteria: - Female subjects who is pregnant, breastfeeding or is considering being pregnant during the study; - History of other malignancies, including hematological tumors, solid tumors except hepatobiliary system; - History of infectious diseases, including hepatis A, B, C, E and tuberculosis.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Only observation
No intervention is needed.

Locations
Country Name City State
China RenJi Hospital Shanghai ???

Sponsors (1)
Lead Sponsor Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The percentage of new occurrence of decompensated liver related events, malignancies, liver transplantation and liver-related death caused by PSC and IgG4-SC describe the characteristics and clinical outcomes of PSC and IgG4-SC patients among multiple medical centers in China 1 year
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