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
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Cholangitis
• Cholangitis, Sclerosing
• IgG4-related Sclerosing Cholangitis
• Primary Sclerosing Cholangitis

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