臨床研究等提出・公開システム

Scientific Title	Efficacy and safety of triclabendazole for the treatment of fasciolosis (Egaten study)
Public Title	Fasciolosis treatment with Egaten (Egaten study)

Contact for Scientific Queries	Name	Maruyama Haruhiko
	Affiliation	University of Miyazaki Hospital
	Address	5200 Kihara, Kiyotake, Miyazaki 889-1692, JAPAN
	Telephone	+81-985-85-0990
	E-mail	hikomaru@med.miyazaki-u.ac.jp
Contact for Public Queries	Name	Maruyama Haruhiko
	Affiliation	University of Miyazaki
	Address	5200 Kihara, Kiyotake, Miyazaki 889-1692, JAPAN
	Telephone	+81-985-85-0990
	E-mail	hikomaru@med.miyazaki-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Aug. 13, 2019
Actual date of first enrollment		Aug. 30, 2019
Target sample size		50
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	1) Patients who are diagnosed as having fasciolosis 2) Patients who give written informed consent 3) Informed consent from proxies are obtained
	Exclusion Criteria	1) Patients who are allergic to Triclabendazole 2) Patients who are pregnant, or possibly pregnant 3) Patients who does not give written informed consent 4) Patients principal investigator judged inappropriate
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Fasciolosis
Intervention(s)		Treatment with un-licensed medicine
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		efficacy rate
Secondary Outcome(s)		1) Decrease in size of hepatic lesion in abdominal CT 2) Decrease in size of Parasite clearance time 3) Appearance of abdominal symptoms 4) Appearance of hepatic dysfunction 5) Appearance of skin eruption

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Japan Agency for Medical Research and Development
Secondary Sponsor	Not applicable

Name of Certified Review Board	Clinical Research Network Fukuoka Certified Review Board
Address	3-1-1 Maidashi,Higashi-ku,Fukuoka, Fukuoka
Telephone	+81-92-643-7171
E-Mail	mail@crnfukuoka.jp
Approval Status	Approval
Date of approval	July. 16, 2019

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history