UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049937 |
|---|---|
| Receipt number | R000056871 |
| Scientific Title | Clinical Study on Efficacy of Pemafibrate in NAFLD (Non-Alcoholic Fatty Liver Disease) Patients with Dyslipidemia |
| Date of disclosure of the study information | 2023/01/10 |
| Last modified on | 2022/12/29 22:40:17 |
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Basic information
Public title
A single-arm study of the efficacy of pemafibrate in patients with NAFLD (non-alcoholic fatty liver disease) complicated by dyslipidemia
Acronym
SPND study
Scientific Title
Clinical Study on Efficacy of Pemafibrate in NAFLD (Non-Alcoholic Fatty Liver Disease) Patients with Dyslipidemia
Scientific Title:Acronym
SPND study
Region
| Japan |
Condition
Condition
NAFLD (non-alcoholic fatty liver disease) complicated by dyslipidemia
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to determine the efficacy of pemafibrate in patients with NAFLD complicated by dyslipidemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AST, ALT, gamma-GTP, ALP, albumin, type4 collagen-7S domain, FIB-4 index, NFS, LSM, CAP after 48 weeks of pemafibrate treatment
Key secondary outcomes
triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol, HOMA-IR after 48 weeks of pemafibrate administration
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pemafibrate 0.1 mg twice daily was administered for 48 weeks, and the patients were evaluated every 12 weeks by examination and blood test.
Fibro-scans were performed before and 48 weeks after pemafibrate administration, respectively.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
NAFLD patients with Dyslipidemia diagnosed by (1) the presence of steatosis in 5% or more of hepatocytes on liver biopsy specimens or fat deposition on ultrasonography; (2) daily alcohol consumption of less than 30g for men and less than 20g for women; and (3) absence of other chronic liver diseases, such as viral hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis, Wilson's disease, and hemochromatosis, as determined by specific laboratory and imaging examinations, as well as the patients' medical histories. Determination of dyslipidemia was defined as serum triglycerides 150 mg/dL or more, low-density lipoprotein (LDL) cholesterol 140 mg/dL or more, or high-density lipoprotein (HDL) cholesterol less than 40 mg/dL or having been treated for dyslipidemia.
Key exclusion criteria
The main exclusion criteria were as follows: (1) age <20 years; (2) new administration of vitamin E, pioglitazone, SGLT2-Is, and GLP-1 RA known to be potentially effective for NAFLD and other antilipidemic agents within 12 weeks prior to pemafibrate treatment; (3) decompensated cirrhosis; and (4) pregnancy or lactation.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Atsukawa |
Organization
Nippon Medical School Hospital
Division name
Gastroenterology and Hepatology
Zip code
113-8603
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
TEL
03-3822-2131
h-ono0@nms.ac.jp
Public contact
Name of contact person
| 1st name | Hroki |
| Middle name | |
| Last name | Ono |
Organization
Nippon Medical School Tamanagayama Hospital
Division name
gastroenterology
Zip code
206-8512
Address
1-7-1, Nagayama, Tama-shi, Tokyo, Japan
TEL
042-371-2111
Homepage URL
h-ono0@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School, gastroenterology, Hiroki Ono
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan
Tel
03-3822-2131
h-ono0@nms.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
| 2023 | Year | 01 | Month | 10 | 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
91
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
| 2020 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 28 | Day |
Last modified on
| 2022 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056871
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| Registered date | File name |
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