UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048297 |
|---|---|
| Receipt number | R000055033 |
| Scientific Title | Specific use-results survey to evaluate the safety and outcome of Pivlaz use in patients after aneurysmal subarachnoid hemorrhage treatment |
| Date of disclosure of the study information | 2022/07/06 |
| Last modified on | 2025/07/08 15:10:01 |
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Basic information
Public title
Specific use-results survey to evaluate the safety and outcome of Pivlaz use in patients after aneurysmal subarachnoid hemorrhage treatment
Acronym
Specific use-results survey to evaluate the safety and outcome of Pivlaz use in patients after aneurysmal subarachnoid hemorrhage treatment
Scientific Title
Specific use-results survey to evaluate the safety and outcome of Pivlaz use in patients after aneurysmal subarachnoid hemorrhage treatment
Scientific Title:Acronym
Specific use-results survey to evaluate the safety and outcome of Pivlaz use in patients after aneurysmal subarachnoid hemorrhage treatment
Region
| Japan |
Condition
Condition
Prevention of cerebral vasospasm, and vasospasm-related cerebral infarction and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage surgery
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and the outcome of Pivlaz use in patients after aneurysmal subarachnoid hemorrhage treatment.
To evaluate the safety and outcomes of Pivlaz use in patients over 75 years of age following treatment for aneurysmal subarachnoid hemorrhage.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
-Adverse events (AE)
-Adverse drug reactions (ADR)
Key secondary outcomes
Outcome
Evaluate the Mortality/morbidity events
-Death
-New cerebral vasospasm
-New cerebral vasospasm-related new cerebral infarction
-New cerebral vasospasm-related delayed ischemic neurological deficit (DIND)
Evaluation of prognosis
-mRS
-GOSE
-MMSE-J
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
Patients after subarachnoid hemorrhage due to cerebral aneurysm to which this drug was administered
Key exclusion criteria
None
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Ryoko |
| Middle name | |
| Last name | Suzuki |
Organization
Nxera Pharma Japan Co., Ltd.
Division name
Drug Safety, PMS
Zip code
107-0052
Address
9-7-2 Akasaka Minato-ku Tokyo 107-0052, Japan
TEL
03-5962-5718
ryoko.suzuki@nxera.life
Public contact
Name of contact person
| 1st name | Ryoko |
| Middle name | |
| Last name | Suzuki |
Organization
Nxera Pharma Japan Co., Ltd.
Division name
Drug Safety, PMS
Zip code
107-0052
Address
9-7-2 Akasaka Minato-ku Tokyo 107-0052, Japan
TEL
03-5962-5718
Homepage URL
ryoko.suzuki@nxera.life
Sponsor or person
Institute
Nxera Pharma Japan Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nxera Pharma Japan 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
None
Address
None
Tel
None
None
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
| 2022 | Year | 07 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.shinryo-to-shinyaku.com/db/pdf/sin_0061_06_0359.pdf
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
| 2022 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2029 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2029 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 07 | Month | 06 | Day |
Last modified on
| 2025 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055033
