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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02917408
Other study ID # PBC-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2016
Est. completion date January 2017

Study information

Verified date November 2020
Source West China Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 769
Est. completion date January 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Newly diagnosis of PBC at West China Hospital during January 2001 to July 2016. Exclusion Criteria: - Simultaneously diagnosed of autoimmune hepatitis or primary sclerosing cholangitis.

Study Design


Locations

Country Name City State
China West China Hospital Chengdu Sichuan

Sponsors (1)

Lead Sponsor Collaborator
Xiaoli Fan

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Description of demographics, management patterns (clinical and diagnostic), comorbidities of PBC patients at diagnosis during the past 16 years. Up to 16 years.
Secondary Evaluation of adverse outcome free survival of the PBC cohort during the 16 years. Up to 16 years.
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