Retrospective Study About Primary Biliary Cholangitis Dur... | NCT02917408

Studies
Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital

NCT02917408

Sponsor

Xiaoli Fan

Status

Completed

Last Update Posted

Nov 10, 2020Actual

Enrollment

769Actual

Phase

Not provided

Conditions

Cholangitis
Liver Cirrhosis, Biliary
Cholestasis
Liver Diseases
Liver Cirrhosis
Bile Duct Diseases

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Jan 2017Actual

Completion Date

Jan 2017Actual

First Submitted Date

Sep 6, 2016

First Submission Date that Met QC Criteria

Sep 26, 2016

First Posted Date

Sep 28, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 7, 2020

Last Update Posted Date

Nov 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

769Actual

Label	Type	Description	Intervention Names
Primary biliary cholangitis during January 2001 to July 2016

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Evaluation of adverse outcome free survival of the PBC cohort during the 16 years.		Up to 16 years.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Li Yang, MD	West China Hospital,Chengdu, Sichuan, China	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
West China Hospital		Chengdu	Sichuan		China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002761	Cholangitis
D008105	Liver Cirrhosis, Biliary
D002779	Cholestasis
D008107	Liver Diseases
D008103	Liver Cirrhosis
D001649	Bile Duct Diseases

Ancestor Terms

ID	Term
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D002780	Cholestasis, Intrahepatic
D005355	Fibrosis

Browse Leaves

Not provided

Browse Branches

Not provided