臨床研究等提出・公開システム

Date of registration	July. 12, 2012
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080221855

Scientific Title	Phase III Clinical Trial, long term treatment with TO-204 - Subcutaneous immunotherapy in patients with HDM-sensitized allergic rhinitis and asthma -
Public Title

Completion Date or Terminated date
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
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
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Torii Pharmaceutical Co., Ltd.
	Address	kaihatsu19431@torii.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		30
Study Type		Interventional
Study Design	Study Design
Study Design	Objective
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	1) Positive test in RAST(specific anti-HDM IgE >= Class 2) 2) Positive skin prick/scratch test against HDM allergen
	Exclusion Criteria	1) Patients with clinical symptoms of perennial rhinitis or asthma caused by allergen other than HDM 2) Patients with severe asthma 3) Patients with severe systemic diseases (i.e., auto-immune disease, immunocomplex disease, immunodeficient disease)
	Minimum Age	5age old over
	Maximum Age	65age old under
	Gender	Both
Health Condition or Problem Studied		Allergic rhinitis or asthma sensitized to house dust mite
Intervention(s)		investigational material(s) Generic name etc : TO-204 INN of investigational material : Therapeutic category code : 449 Other antiallergic agents Dosage and Administration for Investigational material : Subcutaneous administration
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Safety
Secondary Outcome

Primary Sponsor	TORII PHARMACEUTICAL CO., LTD.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-121900
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
13	Dec. 17, 2018	(this page)	Changes
12	July. 09, 2018	Detail	Changes
11	July. 09, 2018	Detail	Changes
10	Dec. 15, 2015	Detail	Changes
9	Dec. 15, 2015	Detail	Changes
8	May. 29, 2015	Detail	Changes
7	May. 29, 2015	Detail	Changes
6	Jan. 07, 2015	Detail	Changes
5	Jan. 07, 2015	Detail	Changes
4	July. 17, 2013	Detail	Changes
3	July. 17, 2013	Detail	Changes
2	July. 12, 2012	Detail	Changes
1	July. 12, 2012	Detail

List of change history