UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039125 |
|---|---|
| Receipt number | R000044621 |
| Scientific Title | Effect of pemafibrate on lipid and bile acid metabolism in patients with fatty liver or primary biliary cholangitis |
| Date of disclosure of the study information | 2020/01/15 |
| Last modified on | 2020/01/29 13:38:03 |
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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
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
kagawa@tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044621
