NCT03322943

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 26, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

3 years

First QC Date

October 8, 2017

Last Update Submit

March 11, 2019

Conditions

Primary Biliary Cholangitis

Keywords

Ursodeoxycholic AcidResponse

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Evaluation whether the PBC patients have response after treatment

    within 1 year

Eligibility Criteria

Age25 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Autoimmune hepatitis Primary sclerosing cholangitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Liver Cirrhosis, Biliary

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesLiver CirrhosisFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Li Yang, MD

    West China Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 8, 2017

First Posted

October 26, 2017

Study Start

January 1, 2016

Primary Completion

December 30, 2018

Study Completion

December 30, 2018

Last Updated

March 13, 2019

Record last verified: 2019-03

Locations

CN(1)