臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 19, 2012
Last modified on	July. 16, 2020
Trial ID	jRCT2091220084

Scientific Title	Japanese POEMS Syndrome with Thalidomide Trial (J-POST trial )
Public Title	Japanese POEMS Syndrome with Thalidomide Trial

Study end date
Performed Number of Subjects
Baseline Characteristics
Participant Flow
Safety Conclusions
Efficacy Conclusions
Discussion and Overall Conclusions
Posted Date
Date of First Publication
Results Links

Plan to Share IPD
Plan Description
Protocol Links

Contact for Scientific Queries	Investigator Name	Sonoko Misawa
	Investigator Organization	Chiba University, Graduate School of Medicine
	Address	Inohana 1-8-1, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
	TEL	+81-43-222-7171
	E-mail	sonoko.m@mb.infoweb.ne.jp
Contact for Public Queries	Contact Name	Sonoko Misawa
	Contact Organization	Chiba University, Graduate School of Medicine
	Address	Inohana 1-8-1, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
	TEL	+81-43-222-7171
	E-mail	sonoko.m@mb.infoweb.ne.jp

Recruitment Status	COMPLETED

Date of First Enrollment		Mar. 22, 2012
Planned Number of Subjects		24
Nature of Investigation		Interventional
Study Design	Description of Trial Design	Multi-center open-label trial
	Type of Control
	Trial Blinding Schema	open(masking not used)
	Randomized	No
Trial Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Patients who complete the precede J-post 10 trial (2) Patients who have an clinicaly probrematic ECG (3) Patients with written informed consent. (4) Patients with informed consent to thalidomide education and risk management system
	Exclusion Criteria	(1) Patients who have severe complications (cardiac failure, renal failure, liver failure) (2) Patients who have recieved oral or intravenous administration of steroid (not including inhalant) (3) Patients who are not appropriate to participate to the trial
	Minimum Age	20age old over
	Maximum Age	No limit
	Sex of Participants	Both
Trial Indication(s)		Crow-Fukase (POEMS) syndrome
Intervention(s)		Intervention type:DRUG Name of intervention:FPF 300 (thalidomide) Dose form / Japanese Medical Device Nomenclature:CAPSULE Route of administration / Site of application:ORAL Dose per administration:100 mg Dosing frequency / Frequency of use:QD Planned duration of intervention:3-6.5 years Intended dose regimen: detailes of teratment arms: Comparative intervention name: Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention: Intended dose regimen:
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Adverse event associated with FPF 300
Secondary Outcome(s)		1. Serum VEGF level 2. Achievement of targeted value (< 1000 pg/ml) of serum VEGF level 3. Motor function(grip strength,ONLS) 4. Median nerve conducton study (conduction velocity, CMAP amplitude, F-wave latency) 5. M protein (immunofixation) 6. Pleural effusion 7. Body weight 8. Response rate 9. Overall survival 10. Progression free survival 11. Time to treatment failure 12. Total adverse event

Primary Sponsor	J-POST Clinical Trial Office
Secondary Sponsor	Hokkaido University, Hokkaido Medical Center, Tohoku University, Chiba University, Saitama Medical University, Niigata University, Shinshu University, Nagoya University, Kinki University, Kobe City Medical Center General Hospital, Yamaguchi University, Kyushu University, Kagoshima University

Sources of funding	Japan Medical Association

Name of Ethics Committee	Chiba University Hospital, Institutional Review Board
Address
TEL	+81-43-222-7171
FAX
E-Mail
Ethics Committee Website
Committee Approval Number
Approved by Ethics Committee	Yes
Reason for Unapproval

Date of approved	Dec. 19, 2011

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Secondary Study ID	Nill Known
Issuer Name

Secondary Study ID	JMA-IIA00084
Issuer Name

Countrie(s) of Recruitment	Japan

History of Changes

No	Publication date
2	July. 16, 2020	(this page)	Changes
1	Mar. 19, 2012	Detail

List of change history