UMIN-CTR Clinical Trial

Basic information
Public title	HEMLIBRA Subcutaneous injection Special Drug Use Surveillance (with Hemophilia A without Inhibitors).
Acronym	HEMLIBRA Special Drug Use Surveillance (with Hemophilia A without Inhibitors).
Scientific Title	HEMLIBRA Subcutaneous injection Special Drug Use Surveillance (with Hemophilia A without Inhibitors).
Scientific Title:Acronym	HEMLIBRA Special Drug Use Surveillance (with Hemophilia A without Inhibitors).
Region	Japan

Condition
Condition	Hemophilia A
Classification by specialty	Hematology and clinical oncology Pediatrics Blood transfusion
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm dose and type of factor VIII agents (hereinafter, called "FVIII") with HEMLIBRA and thrombotic events which may be related to co-administration of FVIII.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. The incidence of thrombotic ADR in patients with FVIII agents. 2. The incidence (time to onset, outcome, treatment state) of thrombotic ADR (thromboembolisms and thrombotic microangiopathy). 3. Dose (type, duration, dosage, reason of administration) of FVIII and HEMLIBRA in patient with thrombotic ADR (thromboembolisms and thrombotic microangiopathy) . 4. Dose (class, duration, dosage, reason of administration) of FVIII in 1 year from first HEMLIBRA administration.
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	Patients in contracted site meet all of the following criteria 1) to 3). 1) Patients with Hemophilia A without Inhibitors. 2) Patients who receive first HEMLIBRA administration from June, 2019 to June, 2020 (exclude previous administration history in other sites). 3) Patients who receive FVIII in follow up period (except for patients who receive only FVIII as regular continuous replacement therapy until a day before second dose of HEMLIBRA).
Key exclusion criteria	No criteria
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Makoto Middle name Last name Nomura
Organization	Chugai Pharmaceutical Co. Ltd.
Division name	Real world data science Dept.
Zip code	103-8324
Address	1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL	03-3273-0769
Email	nomuramkt@chugai-pharm.co.jp

Public contact
Name of contact person	1st name Ayaka Middle name Last name Shimizu
Organization	Chugai Pharmaceutical Co. Ltd.
Division name	Real world data science Dept.
Zip code	103-8324
Address	1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL	03-3273-0905
Homepage URL
Email	nomuramkt@chugai-pharm.co.jp

Sponsor
Institute	Chugai Pharmaceutical Co. Ltd.
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	N/A
Address	N/A
Tel	N/A
Email	N/A

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 07 Month 27 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	2019 Year 03 Month 05 Day
Date of IRB	2019 Year 03 Month 05 Day
Anticipated trial start date	2019 Year 06 Month 24 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Dose and type of factor VIII agents (hereinafter, called "FVIII") with HEMLIBRA and thrombotic events which may be related to co-administration of FVIII.

Management information
Registered date	2019 Year 07 Month 26 Day
Last modified on	2020 Year 02 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042752

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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