NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031240282

Registered date:20/08/2024

Phase 3 study of JR-142 in pediatric patients with growth hormone deficiency

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedGrowth hormone deficiency in children
Date of first enrollment02/09/2024
Target sample size54
Countries of recruitment
Study typeInterventional
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

Outcome(s)

Primary OutcomeChange in height SDS for chronological age from baseline (Week 52)
Secondary Outcome1) Change in height SDS for chronological age from baseline over time 2) Height SDS for chronological age over time 3) Growth velocity 4) Change in growth velocity from baseline 5) Growth velocity SDS over time 6) Height 7) Bone age 8) Bone age relative to chronological age 9) Change in bone age from baseline 10) Change in bone age relative to change in chronological age

Key inclusion & exclusion criteria

Age minimum>= 3age old
Age maximum< 10age old
GenderBoth
Include criteria1) Patients who have not yet reached puberty at the time of screening (Tanner Stage 1) 2) Patients who are between 3 and 10 years of age for boys and between 3 and 8 years of age for girls at the time of the screening test 3) Patients whose calendar age equivalent height at the time of screening test and first dose is less than -2.0 SD of standard height or whose height is in the reference range but whose growth rate is less than -1.5 SD of standard value for more than 2 years
Exclude criteria1) Patients previously treated with GH preparations 2) Patients who have received concomitant treatment within 12 months prior to the screening test that may have an effect on growth promotion 3) Patients using inhaled steroids at doses greater than 400 ug/day of inhaled budesonide or its equivalent within 12 months prior to screening test 4) Patients with conditions other than pediatric GHD that cause short stature (e.g., endocrine disorders, chromosomal abnormalities, malformation syndromes, and bone system diseases) 5) Patients diagnosed with Small for Gestational Age 6) Patients diagnosed with diabetes mellitus and whose blood glucose is not controlled by diet and exercise therapy

Related Information

Contact

Public contact
Name Masahiro Hasegawa
Address 11-18, Kusunoki-cho, Ashiya-shi, 659-0015, Hyogo Hyogo Japan 659-0015
Telephone +81-797-32-8582
E-mail clinical_development@jp.jcrpharm.com
Affiliation JCR Pharmaceuticals Co., Ltd.
Scientific contact
Name Masahiro Hasegawa
Address 11-18, Kusunoki-cho, Ashiya-shi, 659-0015, Hyogo Hyogo Japan 659-0015
Telephone +81-797-32-8582
E-mail clinical_development@jp.jcrpharm.com
Affiliation JCR Pharmaceuticals Co., Ltd.