UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062947 |
|---|---|
| Receipt number | R000071981 |
| Scientific Title | Disease burden, unmet needs, and treatment preferences among patients with haemophilia B in Japan: a mixed-methods study incorporating a discrete choice experiment |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/09/16 12:37:27 |
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Basic information
Public title
Disease burden, unmet needs, and treatment preferences among patients with haemophilia B in Japan: a mixed-methods study incorporating a discrete choice experiment
Acronym
Disease burden, unmet needs, and treatment preferences among patients with haemophilia B in Japan: a mixed-methods study incorporating a discrete choice experiment
Scientific Title
Disease burden, unmet needs, and treatment preferences among patients with haemophilia B in Japan: a mixed-methods study incorporating a discrete choice experiment
Scientific Title:Acronym
Disease burden, unmet needs, and treatment preferences among patients with haemophilia B in Japan: a mixed-methods study incorporating a discrete choice experiment
Region
| Japan |
Condition
Condition
Hemophilia B
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore how adult patients with haemophilia B in Japan experience their disease and current treatments, including impacts on daily life, treatment burden, and unmet needs.
Basic objectives2
Others
Basic objectives -Others
To quantify the relative importance and average utility of key haemophilia B treatment attributes in driving treatment preferences among adult patients with haemophilia B receiving prophylaxis in Japan.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary qualitative outcome will consist of themes derived from de-identified qualitative interview transcripts describing disease experience, treatment burden, unmet needs, and treatment-related decision-making. The primary quantitative outcomes will be DCE-derived RAI and average utility estimates derived from part-worth utilities.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diagnosis of haemophilia B confirmed by a physician.
Currently receiving prophylactic treatment for haemophilia B, defined as regular or ongoing therapy intended to prevent bleeding.
18-65 years of age.
Residency in Japan and ability to read and complete study materials in Japanese.
Key exclusion criteria
Participant is unable to provide informed consent.
Patient is not diagnosed with haemophilia B, for example haemophilia A.
Participant is employed by an entity associated with products for coagulation disorders.
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | Hoel |
| Middle name | |
| Last name | Goisbault |
Organization
CSL Behring K.K.
Division name
Market Access & New Products
Zip code
107-0061
Address
Tokyo Minato-ku Kita-Aoyama 1-2-3
TEL
03-4213-0180
hoel.goisbault@cslbehring.com
Public contact
Name of contact person
| 1st name | Hoel |
| Middle name | |
| Last name | Goisbault |
Organization
CSL Behring K.K.
Division name
Market Access & New Products
Zip code
107-0061
Address
Tokyo Minato-ku Kita-Aoyama 1-2-3
TEL
03-4213-0180
Homepage URL
hoel.goisbault@cslbehring.com
Sponsor or person
Institute
CSL Behring K.K.
Institute
Department
Personal name
Funding Source
Organization
CSL Behring K.K.
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
Non-Profit Organization MINS Institutional Review Board
Address
Tokyo Minato-ku Mita 5-20-9-401
Tel
0364161868
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
| 2026 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2026 | Year | 09 | Month | 16 | Day |
Last modified on
| 2026 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071981
