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Scientific Title	An extension study of phase 2 study of JR-142 in pediatric patients with growth hormone deficiency
Public Title	An extension study of phase 2 study of JR-142 in pediatric patients with growth hormone deficiency

Contact for Scientific Queries	Name	Ibaraki Ryo
	Affiliation	JCR Pharmaceuticals Co., Ltd.
	Address	11-18, Kusunoki-cho, Ashiya-shi, 659-0015, Hyogo
	Telephone	+81-797-32-8582
	E-mail	clinical_development@jp.jcrpharm.com
Contact for Public Queries	Name	Ibaraki Ryo
	Affiliation	JCR Pharmaceuticals Co., Ltd.
	Address	11-18, Kusunoki-cho, Ashiya-shi, 659-0015, Hyogo
	Telephone	+81-797-32-8582
	E-mail	clinical_development@jp.jcrpharm.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Nov. 15, 2021
Actual date of first enrollment		Nov. 16, 2021
Target sample size		24
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	dose comparison control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	A pediatric patient who completed the JR-142-201 study and was judged that there was no problem to participate in this study in terms of safety by principal investigator or sub investigator.
	Exclusion Criteria	A pediatric patient with a diagnosis of diabetes (following the Diagnostic Procedure for Diabetes)
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Growth hormone deficiency in children
Intervention(s)		[Investigational product] JR-142 (INN: redalsomatropin alfa) 0.75 mg/kg/week or 0.5 mg/kg/week, weekly subcutaneous injection [Comparatar product] INN: Somatropin (genetical recombination) 0.175 mg/kg/week, daily subcutaneous injection
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Change in height SDS for chronological age from baseline.
Secondary Outcome(s)

Primary Sponsor	JCR Pharmaceuticals Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Pediatric Clinical Trials Network
Address	2-10-1, Okura, Setagaya-ku, Tokyo
Telephone	+81-3-5497-7297
E-Mail	jctn_cirb@ncchd.go.jp
Approval Status	Approval
Date of approval	Sept. 10, 2021

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