臨床研究等提出・公開システム

Date of registration	Feb. 20, 2018
Last modified on	Nov. 19, 2020
Trial ID	jRCT2080223816

Scientific Title	Phase III Clinical Study on Favipiravir in Patients with Severe Fever with Thrombocytopenia Syndrome -Multi-center, Open-label, historical Control Comparative Study-
Public Title	Phase III Clinical Study on Favipiravir in Patients with Severe Fever with Thrombocytopenia Syndrome

Completion Date or Terminated date	Mar. 09, 2020
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
URL hyperlink(s) related to results and publications

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	FUJIFILM Toyama Chemical Co., Ltd.
	Address
	Phone Number
	E-mail Address	https://www.fujifilm.co.jp/form/fftc/ja/general/input.php?id=FFTCClinical

Contact for Public Queries	Name
	Contact Name for Public Queries	FUJIFILM Toyama Chemical Co., Ltd.
	Address	https://www.fujifilm.co.jp/form/fftc/en/general/input.php?id=FFTCClinicalEn
	Phone Number
	E-mail Address

Recruitment Status	completed

Date of First Enrolment		April. 06, 2018
Target Sample Size		30
Study Type		Interventional
Study Design	Study Design	Multi-center, open-label, historical control comparative study
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	1.Age:20 years old to less than 85 years old 2.Sex: No restriction 3.Outpatient/hospitalization: Hospitalization 4.Patients who are strongly suspected of SFTS
	Exclusion Criteria	1.Patients who have shown a trend toward improvement of symptoms. 2.Patients who are using ribavirin or has used ribavirin for this episode of infection 3.Others
	Minimum Age	20age old over
	Maximum Age	84age old under
	Gender	Both
Health Condition or Problem Studied		Severe Fever with Thrombocytopenia Syndrome (SFTS)
Intervention(s)		investigational material(s) Generic name etc : Favipiravir(T-705) INN of investigational material : Favipiravir Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational material : Oral Multiple Dose 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 efficacy Efficacy and Safety
Secondary Outcome		pharmacokinetics pharmacokinetics

Primary Sponsor	FUJIFILM Toyama Chemical Co., Ltd. (Former Toyama Chemical Co., Ltd.)
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Institutional Review Board,Ehime University Hospital
Address of IRB	Shitsukawa, Toon, Ehime
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Feb. 26, 2018

Secondary ID No.	JapicCTI-183872
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
9	Nov. 19, 2020	(this page)	Changes
8	Nov. 10, 2019	Detail	Changes
7	Dec. 17, 2018	Detail	Changes
6	Oct. 19, 2018	Detail	Changes
5	Oct. 19, 2018	Detail	Changes
4	Oct. 02, 2018	Detail	Changes
3	Oct. 02, 2018	Detail	Changes
2	Feb. 20, 2018	Detail	Changes
1	Feb. 20, 2018	Detail

List of change history