UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047727 |
|---|---|
| Receipt number | R000054380 |
| Scientific Title | Prospective study of patient / patient's caregiver and physician preferences for treatment of hemophilia |
| Date of disclosure of the study information | 2022/05/13 |
| Last modified on | 2022/06/07 17:23:48 |
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Basic information
Public title
Prospective study of patient / patient's caregiver and physician preferences for treatment of hemophilia
Acronym
Prospective study of preferences for treatment of hemophilia
Scientific Title
Prospective study of patient / patient's caregiver and physician preferences for treatment of hemophilia
Scientific Title:Acronym
Prospective Study of Preferences for Treatment of Hemophilia
Region
| Japan |
Condition
Condition
Hemophilia
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine and quantify preferences of patient /patients caregiver and physician for regular treatment of hemophilia
Basic objectives2
Others
Basic objectives -Others
Examine the similarities and differences in perceptions of treatment between patient/patient's caregiver and physician
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Examine the similarities and differences in perceptions of treatment between patient/patient's caregiver and physician (DCE)
Key secondary outcomes
Examine the similarities and differences in perceptions of treatment between patient/patient's caregiver and physician.
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
Patients
1) Age 18 years or older
2) Current without inhibitor
3) Has 6 months or more experience with self-injection of prophylactic treatment with a coagulation factor preparation
4) Willing and able to provide consent, indicating that they understand the purpose and procedures required for the study and are willing to participate in the study
Patient caregivers
1) Caregiver of hemophilia under 18 years
2) Caregiver of patient currently without inhibitor
3) Has 6 months or more experience with injection of prophylactic treatment with a coagulation factor preparation
4) Willing and able to provide consent, indicating that they understand the purpose and procedures required for the study and are willing to participate in the study
Physicians
1) Targeted specialists (general internists medicine, hematologists, pediatrics)
2) Have treated at least one patient with hemophilia with drugs within the past year
3) Willing and able to provide consent, indicating that they understand the purpose and procedures required for the study and are willing to participate in the study
Key exclusion criteria
Those that do not meet the inclusion criteria
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Ayumi |
| Middle name | |
| Last name | Deguchi |
Organization
Novo Nordisk Pharma Ltd
Division name
Medical Affairs Department
Zip code
100-0005
Address
2-1-1 Marunouchi, Chiyoda-ku, Tokyo, Japan
TEL
+81362661000
ayud@novonordisk.com
Public contact
Name of contact person
| 1st name | Michael |
| Middle name | |
| Last name | LoPresti |
Organization
INTAGE Healthcare Inc.
Division name
Health Economics & Outcomes Research Division
Zip code
101-0062
Address
13F Ochanomizu SolaCity, 4-6 Kanda-Surugadai, Chiyoda-ku, Tokyo
TEL
+815036401444
Homepage URL
https://www.intage-healthcare.co.jp/
m.lopresti@intage.com
Sponsor or person
Institute
INTAGE Healthcare, Inc.
Institute
Department
Personal name
Funding Source
Organization
Novo Nordisk Pharma 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
Medical Corporation Keiaikai Saga Memorial Hospital
Address
1240-1 Takagise-cho, Saga City, Saga Prefecture
Tel
0952-31-7771
sagakinen8490917@gmail.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
| 2022 | Year | 05 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Enrolling by invitation
Management information
Registered date
| 2022 | Year | 05 | Month | 12 | Day |
Last modified on
| 2022 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054380
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
