Performance of Scoring Systems in Chinese Patients With P... | NCT03188146

Studies
Performance of Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid

NCT03188146

Sponsor

Humanity and Health Research Centre

Status

Completed

Last Update Posted

Mar 24, 2025Actual

Enrollment

57Actual

Phase

Not provided

Conditions

Primary Biliary Cholangitis (PBC)

Interventions

Ursodeoxycholic Acid

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

Mar 2025

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

May 1, 2017Actual

Primary Completion Date

Feb 15, 2025Actual

Completion Date

Feb 15, 2025Actual

First Submitted Date

Jun 8, 2017

First Submission Date that Met QC Criteria

Jun 14, 2017

First Posted Date

Jun 15, 2017Actual

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

Mar 21, 2025

Last Update Posted Date

Mar 24, 2025Actual

Name	Class
Beijing 302 Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Several risk assessment scoring systems have been proposed to assess the therapeutic response and predict long term prognosis in ursodeoxycholic acid (UDCA)-treated primary biliary cholangitis (PBC) patients, in order to risk stratify PBC patients and guide their management. However there scoring systems have not been fully validated in Chinese population. This study is going to compare the prognostic ability of these criteria, validate the overseas scoring systems, develop and validate a new scoring system in a cohort of Chinese PBC patients.

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

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PBC patients with liver biopsy		Ursodeoxycholic acid will be given compliance to the treatment guideline.	Drug: Ursodeoxycholic Acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ursodeoxycholic Acid	Drug	Standard care of PBC patients	PBC patients with liver biopsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Liver related Death	Whether the patients die from liver-related causes during the follow-up	During follow-up after a year of starting UDCA, an average of 1 year

Secondary Outcomes

Measure	Description	Time Frame
Complications of cirrhosis	Whether the complication of cirrhosis i.e. ascites, hepatic encephalopathy, variceal bleeding occur during the follow-up	During follow-up after a year of starting UDCA, an average of 1 year
Liver transplant

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

With liver biopsy proved PBC

Exclusion Criteria:

A positive serological test for hepatitis B or C virus,
Comorbidity of primary sclerosing cholangitis,
Alcoholic liver disease,
Hemochromatosis,
Wilson's disease,
a1-antitrypsin deficiency
Presence of complications of cirrhosis (Total bilirubin >100 lmol/L, ascites, variceal haemorrhage and hepatic encephalopathy) on admission.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with PBC who are referred to centre of non-infectious liver diseases, Beijing 302 Hospital, Beijing from 2010 will be evaluated.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
George Lau, MD, PhD	Humanity and Health Medical Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre of non-infectious liver diseases, Beijing 302 Hospital, Beijing, China.		Beijing		86	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
D008105	Liver Cirrhosis, Biliary

Ancestor Terms

ID	Term
D002780	Cholestasis, Intrahepatic
D002779	Cholestasis
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014580	Ursodeoxycholic Acid

Ancestor Terms

ID	Term
D003840	Deoxycholic Acid
D002793	Cholic Acids
D001647	Bile Acids and Salts
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided