UMIN-CTR Clinical Trial

Basic information
Public title	Clinical benefit of pemafibrate in patients with primary biliary cholangitis (PBC) with dyslipidemia
Acronym	Clinical benefit of pemafibrate in patients with primary biliary cholangitis (PBC) with dyslipidemia
Scientific Title	Clinical benefit of pemafibrate in patients with primary biliary cholangitis (PBC) with dyslipidemia
Scientific Title:Acronym	Clinical benefit of pemafibrate in patients with primary biliary cholangitis (PBC) with dyslipidemia
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 investigate the clinical benefit and safety of pemafibrate in UDCA(ursodeoxycholic acid)-resistant PBC patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Serum ALP, GGT, AST, ALT, T-Bil, T-chol, HDL-chol, TG levels in 12 months.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	pemafibrate for 12 months
Interventions/Control_2	bezafibrate for 12 months
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	20 years-old <=
Age-upper limit	95 years-old >=
Gender	Male and Female
Key inclusion criteria	UDCA-resistant PBC patients with dyslipidemia
Key exclusion criteria	Exclude patients who meet the following criteria 1) Patients who have already taken pemafibrate 2) Preexisting disorders of being allergic to pemafibrate 3) Pregnant women or breast-feeding women 4) Patients who have already taken statins. 5) Patients by whom principal investigator has determined to be inappropriate as a subject
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Yamashita
Organization	Shinshu University Hospital
Division name	Department of gastroenterology
Zip code	390-8621
Address	3-1-1 Asahi, Matsumoto-city, Nagano Prefecture
TEL	0263-37-2634
Email	ninai@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Yamashita
Organization	Shinshu University Hospital
Division name	Department of gastroenterology
Zip code	390-8621
Address	3-1-1 Asahi, Matsumoto-city, Nagano Prefecture
TEL	0263-37-2634
Homepage URL
Email	ninai@shinshu-u.ac.jp

Sponsor
Institute	Shinshu University Faculty of Medicine, Department of Gastroenterology
Institute
Department

Funding Source
Organization	Shinshu University Faculty of Medicine, Department of Gastroenterology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Shinshu University Faculty of Medicine
Address	3-1-1 Asahi, Matsumoto-city, Nagano Prefecture
Tel	0263-37-2580
Email	mdrinri@shinshu-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	2020 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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	Preinitiation
Date of protocol fixation	2020 Year 01 Month 17 Day
Date of IRB	2020 Year 01 Month 21 Day
Anticipated trial start date	2020 Year 03 Month 01 Day
Last follow-up date	2025 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 01 Month 31 Day
Last modified on	2020 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044745