UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051667 |
|---|---|
| Receipt number | R000058945 |
| Scientific Title | Metreleptin for Subcutaneous Injection Post-Marketing Surveillance |
| Date of disclosure of the study information | 2023/07/31 |
| Last modified on | 2023/07/20 16:37:57 |
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Basic information
Public title
Metreleptin for Subcutaneous Injection Post-Marketing Surveillance
Acronym
Metreleptin for Subcutaneous Injection Post-Marketing Surveillance
Scientific Title
Metreleptin for Subcutaneous Injection Post-Marketing Surveillance
Scientific Title:Acronym
Metreleptin for Subcutaneous Injection Post-Marketing Surveillance
Region
| Japan |
Condition
Condition
Lipodystrophy
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and the efficacy of Metreleptin tablets under clinical practice
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety:
Unexpected adverse drug reactions
Incidence of adverse drug reactions
Key secondary outcomes
Efficacy:
The mean value and the rate of change of HbA1c and blood triglycerides at each observation points
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients who were administrated Metreleptin
Key exclusion criteria
NA
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Masako |
| Middle name | |
| Last name | Kaneto |
Organization
Shionogi & Co., Ltd.
Division name
Pharmacovigilance Department
Zip code
541-0042
Address
8F, Nissay Yodoyabashi East, 3-13, Imabashi 3-Chome, Chuo-ku, Osaka 541-0042, Japan
TEL
+81-80-8522-9302
masako.kaneto@shionogi.co.jp
Public contact
Name of contact person
| 1st name | Tomohisa |
| Middle name | |
| Last name | Hata |
Organization
Shionogi & Co., Ltd.
Division name
Pharmacovigilance Department
Zip code
541-0042
Address
8F, Nissay Yodoyabashi East, 3-13, Imabashi 3-Chome, Chuo-ku, Osaka 541-0042, Japan
TEL
+81-70-7812-6803
Homepage URL
tomohisa.hata@shionogi.co.jp
Sponsor or person
Institute
Pharmacovigilance Department
Shionogi & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NA
Address
NA
Tel
NA
NA
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 | 07 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
No URL
Number of participants that the trial has enrolled
48
Results
Of 48 patients in the safety analysis set, 15 patients (31.25%) experienced an ADR. Of 15 patients in the effectiveness analysis set, the mean value of HbA1c at the final evaluation (n=12) was 6.03%, the rate of change -14.5%, and the mean value of blood triglycerides at the final evaluation (n=15) was 269.3 mg/dL, a rate of change -6.7%.
Results date posted
| 2023 | Year | 07 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
About 70% were female and about 80% were aged 15 to 64 years.
Participant flow
All 48 collected cases were included in safety analysis set, and 15 of them were included in effectiveness analysis set.
Adverse events
Of 48 patients in the safety analysis set, 15 patients (31.25%) experienced an ADR. The adverse reactions that occurred in two or more patients were "decreased appetite" and "neutralizing antibody positive" in 3 cases each, and "injection site erythema", "weight decreased " and "antibody test positive" in 2 cases each.
Outcome measures
Unexpected adverse drug reactions
Incidence of adverse drug reactions
The mean value and the rate of change of HbA1c and blood triglycerides at each observation points
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Regarding to the date of approval by the Ethics Committee, the same date of the protocol confirmation date was entered due to post-marketing surveillance study.
Management information
Registered date
| 2023 | Year | 07 | Month | 20 | Day |
Last modified on
| 2023 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058945
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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