UMIN-CTR Clinical Trial

Basic information
Public title	validation of scoring systems for predicting outcomes of patients with primary biliary cholangitis
Acronym	scoring systems for predicting outcomes in PBC
Scientific Title	validation of scoring systems for predicting outcomes of patients with primary biliary cholangitis
Scientific Title:Acronym	scoring systems for predicting outcomes in PBC
Region	Japan

Condition
Condition	primary biliary cholangitis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To validate whether scoring systems developed in Europe and North America for predicting outcomes of patients with PBC are applicable in Japanese PBC patients
Basic objectives2	Others
Basic objectives -Others	To develop scoring systems for Japanese PBC patients if necessary.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	specificity and sensitivity in predicting outcomes in Japanese PBC patients
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	patients with PBC and 1) observed for at least 2 years, 2) treated with UDCA and/or bezafibrate, and 3) in which outcomes are clearly documented
Key exclusion criteria	PBC patients 1) treated with neither UDCA nor bezafibrate, 2) treated with other drugs, 3) less than 18 years old, 4) having other etiologies for chronic liver diseases
Target sample size	1500

Research contact person
Name of lead principal investigator	1st name Atsushi Middle name Last name Tanaka
Organization	Teikyo University School of Medicine
Division name	Department of Medicine
Zip code	173-8605
Address	Tokyo
TEL	03(3964)1211
Email	a-tanaka@med.teikyo-u.ac.jp

Public contact
Name of contact person	1st name Atsushi Middle name Last name Tanaka
Organization	Teikyo University School of Medicine
Division name	Department of Medicine
Zip code	1738605
Address	Tokyo
TEL	03(3964)1211
Homepage URL
Email	a-tanaka@med.teikyo-u.ac.jp

Sponsor
Institute	Ministry of Health, Labour and Welfare
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Teikyo University School of Medicine
Address	Tokyo
Tel	03(3964)7256
Email	turb-office@teikyo-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 24 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	873
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 09 Day
Date of IRB	2016 Year 06 Month 01 Day
Anticipated trial start date	2016 Year 06 Month 09 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Clinical data are obtained from enrolled PBC patients in each participating facility. Using these data validation of scoring systems are performed.

Management information
Registered date	2016 Year 06 Month 24 Day
Last modified on	2019 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026356