UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050276 |
|---|---|
| Receipt number | R000056841 |
| Scientific Title | Specified Drug Use-Results Survey on "ACOALAN for CAD " |
| Date of disclosure of the study information | 2023/02/08 |
| Last modified on | 2023/02/28 09:57:20 |
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Basic information
Public title
Specified Drug Use-Results Survey on "ACOALAN for CAD "
Acronym
Specified Drug Use-Results Survey on "ACOALAN for CAD "
Scientific Title
Specified Drug Use-Results Survey on "ACOALAN for CAD "
Scientific Title:Acronym
Specified Drug Use-Results Survey on "ACOALAN for CAD "
Region
| Japan |
Condition
Condition
Congenital antithrombin III deficiency (CAD)
Classification by specialty
| Hematology and clinical oncology | Surgery in general | Obstetrics and Gynecology |
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Targeted CAD patients who received ACOALAN, to assess information including tendency of thrombosis, on the occurrence of adverse drug reactions(ADRs) under actual-useconditions, detect unexpected ADRs, and identify factors that may affect the safety and efficacy of the drug in a specified drug use-results survey.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
1.Development of ADR/infectious diseases (type, incident rate, etc.)
2.Investigation of factors considered to affect safety
3.Status of serious adverse events
Effectiveness
1.Effective rate
2.Examination of factors considered to affect the effectiveness
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All CAD patients who received ACOALAN for tendency of thrombosis till the end of survey enrollment.
Key exclusion criteria
When the contract is not concluded
When the number of contract cases has been reached
If the administration start date is out of the contract period
For already registered patients
Patients used for diseases other than approved efficacy benefits
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Takashima |
Organization
Kyowa Kirin Co., Ltd.
Division name
Pharmacovigilance Division
Zip code
1000004
Address
1-9-2 Otemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
umin_acoa.sb@kyowakirin.com
Public contact
Name of contact person
| 1st name | Shuji |
| Middle name | |
| Last name | Horiguchi |
Organization
Shuji Horiguchi
Division name
Pharmacovigilance Division
Zip code
1000004
Address
1-9-2 Otemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
Homepage URL
umin_acoa.sb@kyowakirin.com
Sponsor or person
Institute
Kyowa Kirin Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kyowa Kirin 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
Not applicable for Post marketing special drug use results survey(IRB information necessary)
Address
Not applicable for Post marketing special drug use results survey(IRB information necessary)
Tel
Not applicable for Post marketing special drug use
Not applicable for Post marketing special drug use results survey(IRB information necessary)
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 | 02 | Month | 08 | 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
10
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
| 2015 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | 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
IRB approval is not necessary due to Specified Drug Use-Results Survey. IRB approval date was registered as the same date as protocol fixation date that UMIN system required to fill as an essential field.
Management information
Registered date
| 2023 | Year | 02 | Month | 08 | Day |
Last modified on
| 2023 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056841
