UMIN-CTR Clinical Trial

Basic information
Public title	Validation study of haemophilia-related outcomes on Japanese electronic medical records
Acronym	hemophilia-REAL V study
Scientific Title	Validation study of haemophilia-related outcomes on Japanese electronic medical records
Scientific Title:Acronym	hemophilia-REAL V study
Region	Japan

Condition
Condition	Haemophilia
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop algorithms for identifying patients with hemophilia A and related outcomes in the Real World Data (RWD) database.
Basic objectives2	Others
Basic objectives -Others	Sensitivity, specificity, positive predictive value, and negative predictive value of hemophilia-related outcomes
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Sensitivity, specificity, positive predictive value, and negative predictive value of hemophilia-related outcomes
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Not applicable
Key exclusion criteria	Not applicable
Target sample size	238

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Fujiwara
Organization	Kurashiki Central Hospital
Division name	Department of Otolaryngology Head and Neck Surgery
Zip code	710-8602
Address	1-1-1 Miwa, Kurashiki City, Okayama, Japan
TEL	086-422-0210
Email	tf14817@kchnet.or.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Fujiwara
Organization	Kurashiki Central Hospital, Kurashiki
Division name	Department of Otolaryngology Head and Neck Surgery
Zip code	710-8602
Address	1-1-1 Miwa, Kurashiki City, Okayama, Japan
TEL	086-422-0210
Homepage URL
Email	tf14817@kchnet.or.jp

Sponsor
Institute	Kurashiki Central Hospital, Kurashiki
Institute
Department

Funding Source
Organization	Chugai Pharmaceutical Co., Ltd
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	Research Institute of Healthcare Data Science
Address	12th floor, Sumitomo Shiba Daimon Building 2-5-5 Shiba Daimon, Minato-ku, Tokyo, Japan
Tel	03-5733-5010
Email	rihds@jmdc.co.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	2019 Year 10 Month 06 Day

Related information
URL releasing protocol	Unpublished
Publication of results	Unpublished

Result
URL related to results and publications	Unpublished
Number of participants that the trial has enrolled	236
Results	Unpublished
Results date posted	2020 Year 11 Month 14 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Unpublished
Participant flow	Unpublished
Adverse events	Unpublished
Outcome measures	Unpublished
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 04 Month 11 Day
Date of IRB	2019 Year 04 Month 11 Day
Anticipated trial start date	2019 Year 04 Month 30 Day
Last follow-up date	2019 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2019 Year 10 Month 05 Day
Last modified on	2021 Year 06 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043519