UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052806 |
|---|---|
| Receipt number | R000060164 |
| Scientific Title | Treatment patterns and clinical situation in patients with idiopathic thrombocytopenic purpura (ITP) in Japan: a retrospective claims database study |
| Date of disclosure of the study information | 2023/11/15 |
| Last modified on | 2025/03/10 15:56:29 |
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Basic information
Public title
Treatment patterns and clinical situation in patients with idiopathic thrombocytopenic purpura (ITP) in Japan: a retrospective claims database study
Acronym
Treatment patterns and clinical situation in patients with idiopathic thrombocytopenic purpura (ITP) in Japan: a retrospective claims database study
Scientific Title
Treatment patterns and clinical situation in patients with idiopathic thrombocytopenic purpura (ITP) in Japan: a retrospective claims database study
Scientific Title:Acronym
Treatment patterns and clinical situation in patients with idiopathic thrombocytopenic purpura (ITP) in Japan: a retrospective claims database study
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 clarify the clinical situation of medication in patients with idiopathic thrombocytopenic purpura in Japan, especially corticosteroid prescriptions and their adverse events, and to identify issues related to their medication.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Clinical situation of corticosteroid medication
2.Clinical situation of medication and treatment other than corticosteroid
3.Treatment patterns
Key secondary outcomes
Adverse events in corticosteroid medication
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study population consists of the patients diagnosed with idiopathic thrombocytopenic purpura in the DeSC Claims Database between April 2014 and August 2022 for this study
Key exclusion criteria
Patients with suspected secondary idiopathic thrombocytopenic purpura (splenomegaly, hematologic cancers, hematologic system diseases, immune disorders, malignant tumors)
Patients with idiopathic thrombocytopenic purpura complicating pregnancy
Patients with acute idiopathic thrombocytopenic purpura
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Seiichiro |
| Middle name | |
| Last name | Nyui |
Organization
KISSEI PHARMACEUTICAL CO., LTD.
Division name
Medical
Zip code
103-0022
Address
1-8-9, Nihonbashimuromachi, Chuo-ku, Tokyo
TEL
03-3279-2306
ikuyaku@pharm.kissei.co.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Iwayama |
Organization
KISSEI PHARMACEUTICAL CO., LTD.
Division name
Medical
Zip code
103-0022
Address
1-8-9, Nihonbashimuromachi, Chuo-ku, Tokyo
TEL
03-3279-2306
Homepage URL
kenichi_iwayama@pharm.kissei.co.jp
Sponsor or person
Institute
KISSEI PHARMACEUTICAL CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS
Address
20-9-401, Mita 5-chome, Minato-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
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 | 11 | Month | 15 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000060164
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s12185-024-03897-8
Number of participants that the trial has enrolled
4144
Results
･As for the actual treatment situation in actual clinical practice in Japan, while CS prescriptions are decreasing and the duration of CS administration is shortening, it was confirmed that a certain percentage of patients are still prescribed CS for a long period of time.
･It was confirmed that CS was administered repeatedly even after CS was discontinued.
･The association between risk of outcome and CS prescription was statistically significant.
Results date posted
| 2024 | Year | 08 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Of 16161 subjects with at least one diagnosis of ITP, 4144 patients were included in this study and 1276 patients received corticosteroids. At baseline, the median age was 78 years, 48.99% were male, and 23.77% were inpatients.
Participant flow
This study was a database study using a claims data from DeSC Healthcare, and was conducted on cases that had been diagnosed with ICD10 code:D693 (idiopathic thrombocytopenic purpura) at least once during the data period from April 2014 to August 2022.
Adverse events
Not collected
Outcome measures
The primary outcome was recent trends in ITP treatment (CS prescriptions, change in treatment over time, and treatment patterns).
The secondary outcome was the risk of adverse outcomes associated with CS prescription.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Analysis Contracting Organization]
Intage Healthcare Inc.
[Database Provider]
DeSC Healthcare, Inc.
Management information
Registered date
| 2023 | Year | 11 | Month | 15 | Day |
Last modified on
| 2025 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060164
