臨床研究等提出・公開システム

Date of registration	April. 30, 2020
Last modified on	April. 10, 2025
Trial ID	jRCT1080225183

Scientific Title	multi-center trial of the efficacy and safety of G-1 in patients with sepsis or septic shock
Public Title	multi-center trial of the efficacy and safety of G-1 in patients with sepsis or septic shock

Completion Date or Terminated date	July. 03, 2023
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results	Jan. 17, 2025
URL hyperlink(s) related to results and publications	https://onlinelibrary.wiley.com/doi/10.1111/aor.14943

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	JIMRO Co., Ltd
	Address	-
	Phone Number	+81-3-3469-9070
	E-mail Address	jimro-kaihatsu@otsuka.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	JIMRO Co., Ltd
	Address	-
	Phone Number	+81-3-3469-9070
	E-mail Address	jimro-kaihatsu@otsuka.jp

Recruitment Status	completed

Date of First Enrolment		Oct. 01, 2020
Target Sample Size		83
Study Type		Interventional
Study Design	Study Design	multicenter single arm trial
Study Design	Objective	treatment purpose
Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	1.sepsis and Septic shock (based on J-SSCG 2016) 2.APACHE II score 17-34 3.informed consent was obtained from the patient or the legal representative
	Exclusion Criteria	1.patients who are expected to die within 3 days 2.patients who have not undergone surgical treatment for resectable infected lesions 3.patients who have not passed a year following an organ transplant 4.patients who are expected uncontrollable bleeding by using G-1 5.unidentified patients 6.pregnant, or nursing women
	Minimum Age	18age old over
	Maximum Age	85age old under
	Gender	Both
Health Condition or Problem Studied		sepsis(including sheptic shock)
Intervention(s)		investigational material(s) Generic name etc : G-1 INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : blood purification with G-1, using it 5 times in 3 or 4 days at blood flow rate of 50ml/min for 120min 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		efficacy delta SOFA score safety 28 day mortality
Secondary Outcome		efficacy 6 organ SOFA score, Blood cytokine etc safety Adverse event clinical examination device failure

Primary Sponsor	JIMRO Co., Ltd
Secondary Sponsor	-

Name of Funding Organization	JIMRO Co., Ltd
Name of Research Funding	-

Name of IRB	Fujita Health University Hospital Joint Institutional Review Board
Address of IRB	1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	May. 29, 2020

Secondary ID No.	JapicCTI-205279
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
5	April. 10, 2025	(this page)	Changes
4	June. 13, 2023	Detail	Changes
3	May. 09, 2022	Detail	Changes
2	April. 15, 2021	Detail	Changes
1	May. 28, 2020	Detail

List of change history