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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047727
Receipt No. 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 2022/05/12

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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
Email 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/
Email m.lopresti@intage.com

Sponsor
Institute INTAGE Healthcare, Inc.
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2022 Year 02 Month 15 Day
Date of IRB
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 Before start

Management information
Registered date
2022 Year 05 Month 12 Day
Last modified on
2022 Year 05 Month 12 Day


Link to view the page
URL(English) 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
Registered date File name

Research case data
Registered date File name


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