UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047864 |
|---|---|
| Receipt number | R000054572 |
| Scientific Title | Long-term safety and effectiveness of romiplostim for chronic idiopathic thrombocytopenic purpura in real-world settings |
| Date of disclosure of the study information | 2022/06/01 |
| Last modified on | 2024/10/04 13:32:48 |
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Basic information
Public title
Long-term safety and effectiveness of romiplostim for chronic idiopathic thrombocytopenic purpura in real-world settings
Acronym
Long-term safety and effectiveness of romiplostim for chronic idiopathic thrombocytopenic purpura in real-world settings
Scientific Title
Long-term safety and effectiveness of romiplostim for chronic idiopathic thrombocytopenic purpura in real-world settings
Scientific Title:Acronym
Long-term safety and effectiveness of romiplostim for chronic idiopathic thrombocytopenic purpura in real-world settings
Region
| Japan |
Condition
Condition
Chronic idiopathic thrombocytopenic purpura(chronic ITP)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main objective of this survey is to confirm the safety and efficacy of long-term (2 years) treatment with Romiplate for S.C. Injection in clinical settings by (1) detecting unexpected adverse drug reactions(ADRs), (2) obtaining information on the occurrence of ADRs, (3) identifying factors that may affect the safety and efficacy, and (4) examining primary investigation items, etc.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety assessment:
1. Occurrence of ADRs / infectations (e.g., types and incidence)
2. Identifying factors that may affect the safety
3. Occurrence of serious adverse events
4. Examining primary investigation items
Efficacy assessment:
1. Transition of platelet count
2. Identifying factors that may affect transition of platelet count
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 patients who were treated with Romiplate for s.c. injection. Patients who were treated with Romiplate for diseases other than chronic ITP were also included in this survey.
Key exclusion criteria
None
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kuwazawa |
Organization
Kyowa Kirin Co., Ltd.
Division name
Pharmacovigilance Department
Zip code
100-0004
Address
1-9-2 Otemachi, Chiyoda-ku, Tokyo 100-0004, Japan
TEL
03-5205-7200
pmsrptitp.ve@kyowakirin.com
Public contact
Name of contact person
| 1st name | Yukie |
| Middle name | |
| Last name | Tsuji |
Organization
Kyowa Kirin Co., Ltd.
Division name
Pharmacovigilance Department
Zip code
100-0004
Address
1-9-2 Otemachi, Chiyoda-ku, Tokyo 100-0004, Japan
TEL
03-5205-7200
Homepage URL
pmsrptitp.ve@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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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 | 06 | Month | 01 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s12185-024-03847-4
Number of participants that the trial has enrolled
2076
Results
Refer to the article
Results date posted
| 2022 | Year | 05 | Month | 26 | Day |
Results Delayed
Results Delay Reason
N/A
Date of the first journal publication of results
| 2024 | Year | 09 | Month | 29 | Day |
Baseline Characteristics
Refer to the article
Participant flow
Refer to the article
Adverse events
Refer to the article
Outcome measures
Refer to the article
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2011 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2011 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Surveillance following all-case surveillance method
Management information
Registered date
| 2022 | Year | 05 | Month | 26 | Day |
Last modified on
| 2024 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054572
