UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055404 |
|---|---|
| Receipt number | R000063316 |
| Scientific Title | Effects of pemafibrate on liver inflammation and fibrosis in patients with metabolic dysfunction associated steatotic liver disease complicated by hypertriglyceridemia: A multi-center prospective observational study |
| Date of disclosure of the study information | 2024/09/03 |
| Last modified on | 2024/09/03 14:40:50 |
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Basic information
Public title
Effects of pemafibrate on liver inflammation and fibrosis in patients with metabolic dysfunction associated steatotic liver disease complicated by hypertriglyceridemia: A multi-center prospective observational study
Acronym
PLIANT
Scientific Title
Effects of pemafibrate on liver inflammation and fibrosis in patients with metabolic dysfunction associated steatotic liver disease complicated by hypertriglyceridemia: A multi-center prospective observational study
Scientific Title:Acronym
PLIANT
Region
| Japan |
Condition
Condition
Metabolic dysfunction associated steatotic liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of pemafibrate on liver inflammation and fibrosis in patients with metabolic dysfunction associated steatotic liver disease complicated by hypertriglyceridemia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in SWD from baseline to 48 weeks
Key secondary outcomes
Change in SWD from baseline to 24 weeks.
Change in imaging examination, fibrosis markers from baseline to 24 and 48 weeks.
Change in physical examination, blood tests from baseline to 12, 24, 36 and 48 weeks.
Change in ferritin, liver/spleen CT ratio (L/S ratio), visceral fat area, muscle mass at the L3 level, grip strength, lean mass, body fat mass, muscle mass, skeletal muscle mass, skeletal muscle index, and liver tissue score from baseline to 48 weeks.
Relationship between various indices.
Incidence of adverse events and adverse drug reactions.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with hypertriglyceridemia (fasting TG>=150 mg/dL or non-fasting TG>=175 mg/dL).
2) Patients who started to use pemafibrate, and who give their consent to participate in this study within 8 weeks after the start of prescription of it.
3) Patient has been diagnosed with steatotic liver disease by imaging examination.
4) Patients with Chronic hepatitis (ALT>30IU/L).
5) Patients whose ages are between 18 and 80 years old at the time of obtaining consent.
Key exclusion criteria
1)Patients who are prohibited to use pemafibrate
Patients with known hypersensitivity to pemafibrate or to any of the excipients
Patients with severe hepatic disorder, Child-Pugh grade B or C cirrhosis, or biliary obstruction
Patients with cholelithiasis
Pregnant or possibly pregnant women
Patients receiving concomitant cyclosporine or rifampicin
2)Patients with chronic liver disease other than MASLD
Drug-induced liver injury
Autoimmune hepatitis
Primary biliary cholangitis
Primary sclerosing cholangitis
3)Patients whose daily drinking amount is more than 30 g per day for men and more than 20 g for women in terms of ethanol
4) Patients who have started using the following drugs or changed their dosage within 12 weeks prior to obtaining consent
Pioglitazone, GLP-1 receptor agonists, SGLT2 inhibitors, GIP/GLP-1 receptor agonists
HMG-CoA reductase inhibitors (statins)
Other fibrates
ARBs, ACE inhibitors
Vitamin E
5) Patients with other conditions that the investigators judge to be inappropriate for the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shunsuke |
| Middle name | |
| Last name | Nakajima |
Organization
Asahikawa Medical University
Division name
Department of Emergency Medicine
Zip code
0788510
Address
2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
TEL
0166682852
naka-g@asahikawa-med.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Nakajima |
Organization
Asahikawa Medical University
Division name
Department of Emergency Medicine
Zip code
0788510
Address
2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
TEL
0166682852
Homepage URL
naka-g@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Kowa company, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nayoro City General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University Research Ethics Committee
Address
2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido, Japan
Tel
0166682297
rs-kp.g@asahikawa-med.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
| 2024 | Year | 09 | Month | 03 | 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
| 2024 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 03 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multi-center, prospective observational study
Items: abdominal ultrasound, MRI, general biochemical blood test, fibrosis markers, etc.
Management information
Registered date
| 2024 | Year | 09 | Month | 03 | Day |
Last modified on
| 2024 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063316
