UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057096 |
|---|---|
| Receipt number | R000065155 |
| Scientific Title | A retrospective observational study of fostamatinib in patients with idiopathic thrombocytopenic purpura |
| Date of disclosure of the study information | 2025/02/20 |
| Last modified on | 2025/08/21 09:19:18 |
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Basic information
Public title
A retrospective observational study of fostamatinib in patients with idiopathic thrombocytopenic purpura
Acronym
A retrospective observational study of fostamatinib in patients with idiopathic thrombocytopenic purpura
Scientific Title
A retrospective observational study of fostamatinib in patients with idiopathic thrombocytopenic purpura
Scientific Title:Acronym
A retrospective observational study of fostamatinib in patients with idiopathic thrombocytopenic purpura
Region
| Japan |
Condition
Condition
idiopathic thrombocytopenic purpura
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety and efficacy of fostamatinib in patients with idiopathic thrombocytopenic retrospectively in Fujisawa City Hospital
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of patients who achieved platelet of 30,000 /microliter or higher and twice or more compared with the baseline value at least once within 24 weeks after initiation of fostamatinib
Key secondary outcomes
1. Proportion of patients whose platelet is 50,000 /microliter or higher at 1, 2, 4, 8, 12, 16, 20, and 24 weeks after initiation of fostamatinib
2. Proportion of patients whose platelet is 30,000 /microliter or higher and twice or more compared with the baseline value at 1, 2, 4, 8, 12, 16, 20, and 24 weeks after initiation of fostamatinib
3. Proportion of patients whose platelet is 100,000 /microliter or higher at 1, 2, 4, 8, 12, 16, 20, and 24 weeks after initiation of fostamatinib
4. Time course of platelet response in each patient
5. Duration required to achieve platelet of 50,000 /microliter or higher and duration maintaining it
6. Time course of platelet in each patient
7. Frequency of hemorrhage events from the initiation of fostamatinib to 24 weeks after
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria can be enrolled in this study;
1.Patients with idiopathic thrombocytopenic purpura
2.Patients who received fostamatinib at least once in accordance with its package insert after April 2023
3.Patients aged 18 years or older at giving their consent or at day of publication of opt-out document
4.Patients who give their consent in written form by their free will after understanding of the contents of this study, or patients who do not refuse to use their medical records in this study by opt-out in case that they do not continue visiting Fujisawa City Hospital at day of the initiation of this study (at day of IRB approval)
Key exclusion criteria
Patients who fall into any of the following criteria cannot be enrolled;
1. Patients who refuse to use their medical records in this study
2. Patients who need regal representatives
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | Katsumichi |
| Middle name | |
| Last name | Fujimaki |
Organization
Fujisawa City Hospital
Division name
Department of hematology
Zip code
251-8550
Address
2-6-1, Fujisawa, Fujisawa, Kanagawa
TEL
0466-25-3111
kkfujimaki@gmail.com
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Takayama |
Organization
EviPRO Co., Ltd.
Division name
Clinical Study Support Division
Zip code
101-0032
Address
KDX Iwamoto-cho building 2F, 3-11-9, Iwamoto-cho, Chiyoda, Tokyo
TEL
03-5829-4110
Homepage URL
htak@evipro.co.jp
Sponsor or person
Institute
Fujisawa City Hospital
Institute
Department
Personal name
Funding Source
Organization
KISSEI PHARMACEUTICAL 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
Ethical Review Committee of Fujisawa City Hospital
Address
2-6-1, Fujisawa, Fujisawa, Kanagawa
Tel
0466-25-3111
chiken2@fujisawa-city-hospital.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
| 2025 | Year | 02 | Month | 20 | 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
12
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
| 2024 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study collect medical records from the day of diagnosis of idiopathic thrombocytopenic purpura to the day of IRB approval retrospectively of all eligible patients with idiopathic thrombocytopenic purpura who received fostamatinib after April 2023 at Fujisawa City Hospital
Management information
Registered date
| 2025 | Year | 02 | Month | 20 | Day |
Last modified on
| 2025 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065155
