臨床研究等提出・公開システム

Japanese

Date of registration	Feb. 19, 2021
Last modified on	Aug. 06, 2024
Trial ID	jRCT2031200372

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

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

Recruitment status	Complete

Anticipated date of first enrollment		Mar. 01, 2021
Actual date of first enrollment		May. 21, 2021
Target sample size		24
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) A pediatric patient who has not developed their puberty at the time of the first dose (A pediatric patient who is at Tanner Stage 1) 2) A male aged from 3 years to 10 years and 6 months and a female aged from 3 years to 9 years at the time of the first dose 3) A pediatric patient with -2.0 or less height SDS for chronological age at the time of screening test and the first dose
	Exclusion Criteria	1) A pediatric patient who have previously been treated with GH 2) A pediatric patient treated with adrenocortical hormone preparations, anabolic steroid preparations, thyroid hormone preparations, androgen preparations, follicular hormone preparations, luteinizing hormone preparations, Gn-RH derivatives, and IGF-1 preparations that may affect growth promotion within 24 months prior to screening test (for adrenocortical hormone preparations, excluding topical preparations and the use for not more than 1 week consecutively) 3) A pediatric patient with diseases causing short stature other than pediatric GHD (endocrine disorders, chromosomal abnormalities, malformation syndromes, bone system diseases, etc.) 4) A pediatric patient with a diagnosis of diabetes (following the Diagnostic Procedure for Diabetes)
	Age Minimum	3age old over
	Age Maximum	10age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Growth hormone deficiency in children
Intervention(s)		[Investigational product] JR-142 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 (after 26 weeks)
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	+81-3-3416-0181
E-Mail
Approval Status	Approval
Date of approval	Mar. 16, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
7	Aug. 06, 2024	(this page)	Changes
6	Aug. 01, 2023	Detail	Changes
5	Aug. 07, 2022	Detail	Changes
4	April. 23, 2022	Detail	Changes
3	April. 21, 2021	Detail	Changes
2	April. 12, 2021	Detail	Changes
1	Feb. 19, 2021	Detail

List of change history