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NCT03322943 Clinical Trial

The Comparison About the Response of Ursodeoxycholic Acid in Primary Biliary Cholangitis Only and Primary Biliary Cholangitis With High Immune Globulin G or Aminotransferase at West China Hospital

Primary Biliary Cholangitis Clinical Trial

Official title:
The Comparison About the Response of Ursodeoxycholic Acid in Primary Biliary Cholangitis Only and Primary Biliary Cholangitis With High Immune Globulin G or Aminotransferase at West China Hospital

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03322943
Other study ID # PBC-2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date December 30, 2018

Study information
Verified date March 2019
Source West China Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates the different response of Ursodeoxycholic Acid in primary biliary cholangitis only and primary biliary cholangitis with high immune globulin G or aminotransferase at West China Hospital from 2008-2017.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date December 30, 2018
Est. primary completion date December 30, 2018
Accepts healthy volunteers No
Gender All
Age group 25 Years to 85 Years
Eligibility Inclusion Criteria:

Patients diagnosed with primary biliary cholangitis Treated with Ursodeoxycholic Acid in West China Hospital for at least 1 year

Exclusion Criteria:

Autoimmune hepatitis Primary sclerosing cholangitis

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China West China Hospital Chengdu Sichuan

Sponsors (1)
Lead Sponsor Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Description of demographics, clinical index after treatment age,sex,ALT(IU/L),AST(IU/L),ALP(IU/L),GGT(IU/L),IgG(g/L) up to 1 year
Secondary Evaluation whether the PBC patients have response after treatment Use Paris II criterion to estimate within 1 year
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