UMIN-CTR Clinical Trial

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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