臨床研究等提出・公開システム

Date of registration	Jan. 04, 2016
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080223060

Scientific Title	Safety study of NaPPS in pediatric patients with mucopolysaccharidosis type VI
Public Title

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	ReqMed Company, Ltd.
	Address	tiken@reqmed.co.jp
	Phone Number
	E-mail Address

Recruitment Status	completed

Date of First Enrolment
Target Sample Size		2
Study Type		Interventional
Study Design	Study Design	Non-randomized, open-label, dose-escalation study followed by continuous administration study
Study Design	Objective
Phase		1-2
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Patients who are confirmly diagnosed with Mucopolysaccharidosis type VI and have assessable symptoms of cartilage and bone. (2) Patients who are able to explain their own condition or to show their own intention. (3) Patients who are able to walk for 6 minutes continuously.
	Exclusion Criteria
	Minimum Age	6age old over
	Maximum Age	14age old under
	Gender	Both
Health Condition or Problem Studied		mucopolysaccharidosis type VI
Intervention(s)		investigational material(s) Generic name etc : NaPPS INN of investigational material : Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : One time a week, subcutaneous injection
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome
Secondary Outcome

Primary Sponsor	ReqMed Company, 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-163114
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
3	Dec. 17, 2018	(this page)	Changes
2	Jan. 05, 2016	Detail	Changes
1	Jan. 04, 2016	Detail

List of change history