NCT02917408

Brief Summary

Retrospective study of all patients diagnosed with primary biliary cholangitis during January 2001 to July 2016 at West China Hospital by review of medical records. The following variables will be retrospectively studied: age, sex, first symptoms, clinical characteristics, pathology, treatment, stage, complications of cirrhosis, other autoimmune diseases and long-term outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
769

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 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

September 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

September 6, 2016

Last Update Submit

November 7, 2020

Conditions

CholangitisLiver Cirrhosis, BiliaryCholestasisLiver DiseasesLiver CirrhosisBile Duct Diseases

Outcome Measures

Primary Outcomes (1)

  • Description of demographics, management patterns (clinical and diagnostic), comorbidities of PBC patients at diagnosis during the past 16 years.

    Up to 16 years.

Secondary Outcomes (1)

  • Evaluation of adverse outcome free survival of the PBC cohort during the 16 years.

    Up to 16 years.

Study Arms (1)

Primary biliary cholangitis during January 2001 to July 2016

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients diagnosed with primary biliary cholangitis during January 2001 to July 2016 at West China Hospital by review of medical records.

You may qualify if:

  • Newly diagnosis of PBC at West China Hospital during January 2001 to July 2016.

You may not qualify if:

  • Simultaneously diagnosed of autoimmune hepatitis or primary sclerosing cholangitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

CholangitisLiver Cirrhosis, BiliaryCholestasisLiver DiseasesLiver CirrhosisBile Duct Diseases

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesCholestasis, IntrahepaticFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Li Yang, MD

    West China Hospital,Chengdu, Sichuan, China

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

September 6, 2016

First Posted

September 28, 2016

Study Start

September 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

November 10, 2020

Record last verified: 2020-11

Locations

CN(1)