UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056640 |
|---|---|
| Receipt number | R000064740 |
| Scientific Title | Immunoglobulin replacement therapy (IgRT) preference for attributes of patients with primary immunodeficiency diseases (PID) in Japan |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2026/01/19 16:00:37 |
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Basic information
Public title
Immunoglobulin replacement therapy (IgRT) preference for attributes of patients with primary immunodeficiency diseases (PID) in Japan
Acronym
Immunoglobulin replacement therapy (IgRT) preference for attributes of patients with primary immunodeficiency diseases (PID) in Japan
Scientific Title
Immunoglobulin replacement therapy (IgRT) preference for attributes of patients with primary immunodeficiency diseases (PID) in Japan
Scientific Title:Acronym
Immunoglobulin replacement therapy (IgRT) preference for attributes of patients with primary immunodeficiency diseases (PID) in Japan
Region
| Japan |
Condition
Condition
Primary immunodeficiency diseases
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
･To determine the administration preference of IgRT in patients with PID
･To determine the association between patient or caregiver (in case of patients <12 years of age) characteristics and preferences
･To determine overall relative preferences of administration attributes
Basic objectives2
Others
Basic objectives -Others
Web-based survey
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Administration preferences of IgRT
･Treatment location of IgRT
･Hospital visits frequency
･IgRT frequency
･IgRT time per administration
･Time spent in hospital (Total time spent in hospital from reception to receiving medicines)
･Headache/Fever (within 24 hours after IgRT administration)
･Swelling at the injection site (within 24 hours after IgRT administration)
Key secondary outcomes
Patients Background
･Age
･Gender
･Weight
･Disease name
･Other treatment besides IgRT
･History of IgRT type
･Volume of IVIg product
･Type of device for SCIg product
･Sufficiency of current IgRT
･Reason of the selection of IVIg/SCIg
･Knowledge of IgG through values
･Employment/schooling status of patients/caregivers
･Time from home to hospital
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
| 2 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
･Patients who have been diagnosed with PID, or caregivers of patients with PID (if patient is below 12 years of age)
･Patients receiving IVIg or SCIg at least once a month for more than 6 months of treatment
･Patients aged 2 years or older at the time of informed consent
･Has signed (or if applicable, a legal representative has signed) an informed consent form before undergoing any study procedures
･Patients or caregivers who are living in Japan (at least during the study period)
･Patients or caregivers who have a device with internet access to answer the study questionnaire
Key exclusion criteria
･Less than 6 months on IgRT
･Patients or caregivers who are not expected to respond to the study questionnaire
･Patients or caregivers who work for Takeda/CRO or who have family members working in Takeda/CRO
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Kikutani |
Organization
Takeda Pharmaceutical Company Limited
Division name
Japan Medical Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo
TEL
090-6944-0270
masayoshi.kikutani@takeda.com
Public contact
Name of contact person
| 1st name | Madoka |
| Middle name | |
| Last name | Go |
Organization
Takeda Pharmaceutical Company Limited
Division name
Japan Medial Office
Zip code
103-8668
Address
1-1, Nihonbashi-Honcho 2-Chome, Chuo-ku, Tokyo
TEL
090-1872-0300
Homepage URL
madoka.go@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
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
Japan Conference of Clinical Research
Address
1-13-23 Minamiikebukuro, Toshima-ku, Tokyo
Tel
03-6868-7022
jccr-info@jccr.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 | 01 | Month | 06 | 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
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 | 11 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a prospective, observational study, and a web survey for patients with PID to determine the administration preference of IgRT. It will be conducted for 6 months. The data obtained in this study is anonymized and individuals cannot be identified.
Management information
Registered date
| 2025 | Year | 01 | Month | 06 | Day |
Last modified on
| 2026 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064740
