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

March 11, 2019 updated by: Li Yang, West China Hospital
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients diagnosed with primary biliary cholangitis and treated with Ursodeoxycholic Acid at West China Hospital by review of medical records.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of demographics, clinical index after treatment
Time Frame: up to 1 year
age，sex，ALT（IU/L），AST（IU/L），ALP（IU/L），GGT（IU/L）,IgG（g/L）
up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation whether the PBC patients have response after treatment
Time Frame: within 1 year
Use Paris II criterion to estimate
within 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ACTUAL)

December 30, 2018

Study Completion (ACTUAL)

December 30, 2018

Study Registration Dates

First Submitted

October 8, 2017

First Submitted That Met QC Criteria

October 23, 2017

First Posted (ACTUAL)

October 26, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBC-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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