臨床研究等提出・公開システム

Japanese

Date of registration	April. 08, 2022
Last modified on	April. 08, 2022
Trial ID	jRCT2031220005

Scientific Title	An Open-label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Japanese Adults with Chronic Immune Thrombocytopenia
Public Title	Phase 3 study to Evaluate the Efficacy and Safety of Avatrombopag in Japanese Adults with Chronic Immune Thrombocytopenia

Contact for Scientific Queries	Name	Shimizu Yasuko
	Affiliation	CMIC Co., Ltd.
	Address	Hamamatsucho Building, 1-1-1, Minato-ku, Shibaura, Tokyo,
	Telephone	+81-3-6779-8000
	E-mail	ClinicalTrialInformation@cmic.co.jp
Contact for Public Queries	Name	Shimizu Yasuko
	Affiliation	CMIC Co., Ltd.
	Address	Hamamatsucho Building, 1-1-1, Minato-ku, Shibaura, Tokyo,
	Telephone	+81-3-6779-8000
	E-mail	ClinicalTrialInformation@cmic.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 08, 2022
Actual date of first enrollment
Target sample size		19
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	-Men and women >_18 years of age. -Subject has a confirmed diagnosis of chronic ITP (>_12 months duration) and has had an insufficient response to a previous ITP treatment, in the opinion of the Investigator. -Subject has an average of 2 platelet counts <30x10^9/L (no single count can be >35x10^9/L). The 2 samples must be obtained >_48 hours and <_2 weeks apart.
	Exclusion Criteria	'-Subjects with known secondary immune thrombocytopenia (e.g., with known Helicobacter pylori-induced ITP, subjects infected with known human immunodeficiency virus [HIV] or hepatitis C virus [HCV] or subjects with known systemic lupus erythematosus). -Subjects with known inherited thrombocytopenia (e.g., MYH-9 disorders) or hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency).
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Chronic Immune Thrombocytopenia
Intervention(s)		Subjects will receive a starting dose of 20 mg avatrombopag once daily and will be allowed to change their dose and dosing frequency (maximum dose 40 mg daily, minimum dose 20 mg once weekly) in accordance with their individual platelet responses.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		The cumulative number of weeks in which the platelet count is >_50x10^9/L during 26 weeks of treatment in the absence of rescue therapy
Secondary Outcome(s)		Platelet response rate at Day 8 (as defined by the proportion of subjects with a platelet response >_50x10^9/L at Day 8).

Primary Sponsor	Sobi, Inc.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Nippon Medical School Hospital Institutional Review Board
Address	1-1-5 Sendagi, Bunkyo-ku, Tokyo
Telephone	+81-3-3822-2131
E-Mail
Approval Status	Not approval
Date of approval

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none