臨床研究等提出・公開システム

Date of registration	Aug. 20, 2019
Last modified on	Aug. 31, 2022
Trial ID	jRCT2080224835

Scientific Title	A PHASE I/II STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF NXT007 IN HEALTHY VOLUNTEERS AND PATIENTS WITH HEMOPHILIA A (NXTAGE)
Public Title	NXT007_Hemophilia-A_NXT001JG (NXTAGE)

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	recruiting

Date of First Enrolment		Aug. 27, 2019
Target Sample Size		106
Study Type		Interventional
Study Design	Study Design	A randomized, double-blind, placebo-controlled, inter-individual dose-escalation study
Study Design	Objective	treatment purpose
Phase		1-2
Key inclusion & exclusion criteria	Inclusion Criteria	[Healthy volunteer] - Japanese - Age 20 - 44 years, inclusive [Patient] - Severe congenital hemophilia A - Age 12 - 59 years, inclusive - Documented bleeding episodes (bleeding period, bleeding site) and the therapeutic history with blood coagulation factor products for 24 weeks prior to enrollment
	Exclusion Criteria	[Healthy volunteer] - Previous or concomitant thromboembolic (TE) disease such as deep vein thrombosis (DVT), or signs of TE disease or thrombotic microangiopathy (TMA) [Patient] - Bleeding disorder other than congenital hemophilia A - Previous or concomitant thromboembolic (TE) disease such as deep vein thrombosis (DVT), or signs of TE disease or thrombotic microangiopathy (TMA) - Planned immune tolerance induction (ITI) therapy during the study period
	Minimum Age	12age old over
	Maximum Age	59age old under
	Gender	Male
Health Condition or Problem Studied		Hemophilia A
Intervention(s)		investigational material(s) Generic name etc : NXT007 INN of investigational material : - Therapeutic category code : 639 Other biological preparations Dosage and Administration for Investigational material : Single and multiple administration of several doses of NXT007 control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : Single administration of placebo
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety efficacy pharmacokinetics pharmacodynamics Safety, efficacy, phamacodynamics, pharmacokinetics
Secondary Outcome		other Immunogenecity

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

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Institutional Review Board of Showa University Karasuyama Hospital
Address of IRB	6-11-11, Kitakatasuyama, Setagaya-ku, Tokyo, Japan
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Aug. 02, 2019

Secondary ID No.	JapicCTI-194919
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan

History of Changes

No	Publication date
4	Aug. 31, 2022	(this page)	Changes
3	May. 17, 2021	Detail	Changes
2	June. 26, 2020	Detail	Changes
1	Aug. 21, 2019	Detail

List of change history