UMIN-CTR Clinical Trial

Basic information
Public title	Effect of pemafibrate on lipid and bile acid metabolism in patients with fatty liver or primary biliary cholangitis
Acronym	Effect of pemafibrate on lipid and bile acid metabolism in patients with fatty liver or primary biliary cholangitis
Scientific Title	Effect of pemafibrate on lipid and bile acid metabolism in patients with fatty liver or primary biliary cholangitis
Scientific Title:Acronym	Effect of pemafibrate on lipid and bile acid metabolism in patients with fatty liver or primary biliary cholangitis
Region	Japan

Condition
Condition	fatty liver, PBC
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of pemafibrate on lipid and bile acid metabolism
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hepatic fat evaluated by MRS in 6 months (fatty liver patients) Serum ALP levels in 6 months (PBC patients)
Key secondary outcomes

Base
Study type	Observational

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with hypertriglycemia who have fatty liver or PBC
Key exclusion criteria	1. severe liver dysfunction (C-P B or C) 2. moderate or severe renal dysfunction 3. gallstone 4. pregnant women
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Tatehiro Middle name Last name kagawa
Organization	Tokai University School of Medicine
Division name	Division of Gastroenterology and Hepatology, Department of Internal Medicine,
Zip code	259-1193
Address	143 Shimokasuya, Isehara
TEL	0463-93-1121
Email	kagawa@tokai.ac.jp

Public contact
Name of contact person	1st name Tatehiro Middle name Last name Kagawa
Organization	Tokai University School of Medicine
Division name	Division of Gastroenterology and Hepatology, Department of Internal Medicine,
Zip code	259-1193
Address	143 Shimokasuya, Isehara
TEL	0463-93-1121
Homepage URL
Email	kagawa@tokai.ac.jp

Sponsor
Institute	Tokai University School of Medicine
Institute
Department

Funding Source
Organization	Tokai University School of Medicine
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	Tokai University School of Medicine, IRB
Address	143 Shimokasuya, Isehara
Tel	0463-93-1121
Email	tokai-rinsho@ml.tokai-u.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 01 Month 15 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	Open public recruiting
Date of protocol fixation	2019 Year 08 Month 19 Day
Date of IRB	2019 Year 07 Month 01 Day
Anticipated trial start date	2020 Year 01 Month 15 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We enroll the patients with fatty liver or PBC who have hypertriglycemia and receive pemafibrate treatment (0.1 mg, bid). We analyze the change in hepatic fat evaluated by MRS (fatty liver patients) and serum ALP (PBC patients) in 6 months.

Management information
Registered date	2020 Year 01 Month 10 Day
Last modified on	2020 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044621