臨床研究等提出・公開システム

Date of registration	April. 09, 2019
Last modified on	June. 27, 2022
Trial ID	jRCT1080224629

Scientific Title	A MULTICENTER, OPEN-LABEL, POST-MARKETING STUDY TO EVALUATE THE LONG-TERM SAFETY AND JOINT HEALTH WITH ADMINISTRATION OF EMICIZUMAB IN HEMOPHILIA A PEDIATRIC PATIENTS AGED LESS THAN 12 YEARS WITHOUT FVIII INHIBITORS
Public Title	Post Marketing Study of emizibumab in hemophilia A pedicatric patients less than 12 years without FVIII Inhibitors(AOZORA)

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Chugai Pharmaceutical Co., Ltd.
	Address
	Phone Number
	E-mail Address	clinical-trials@chugai-pharm.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Chugai Pharmaceutical Co., Ltd.
	Address
	Phone Number
	E-mail Address	clinical-trials@chugai-pharm.co.jp

Recruitment Status	completed

Date of First Enrolment		May. 13, 2019
Target Sample Size		30
Study Type		Interventional
Study Design	Study Design	a multicenter, open-label, single-arm
Study Design	Objective	treatment purpose
Phase		4
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Aged <12 years at the time of informed consent (2) Body weight >3 kg at the time of informed consent (3) Diagnosis of severe (endogenous FVIII level <1%) congenital hemophilia A (4) Negative results for FVIII inhibitors (<0.6 BU/mL) in the most recent assay within 8 weeks prior to enrollment
	Exclusion Criteria	(1) Inherited or acquired bleeding disorder other than hemophilia A (2) Current receipt of immune tolerance induction (ITI) therapy (3) Previous (within the past 12 months) or current treatment for thromboembolic disease (except patients with previous catheter-associated thrombus who are not currently receiving treatment) or signs of thromboembolic disease
	Minimum Age	No limit
	Maximum Age	11age old under
	Gender	Both
Health Condition or Problem Studied		Hemophilia A
Intervention(s)		investigational material(s) Generic name etc : emicizumab INN of investigational material : emicizumab Therapeutic category code : 634 Human blood preparations Dosage and Administration for Investigational material : once every week or 2 weeks (QW or 2QW) or every 4 weeks (Q4W) subcutaneous administration control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety exploratory Observation, Laboratory tests
Secondary Outcome		exploratory Observation

Primary Sponsor	Chugai Pharmaceutical Co., Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	St. Marianna University Group Institutional Review Board
Address of IRB
Phone Number of IRB	+81-44-977-8111
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Feb. 19, 2019

Secondary ID No.	JapicCTI-194701
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
5	June. 27, 2022	(this page)	Changes
4	June. 25, 2021	Detail	Changes
3	June. 22, 2020	Detail	Changes
2	Aug. 23, 2019	Detail	Changes
1	April. 12, 2019	Detail

List of change history