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

JRCT ID: jRCT2031210366

Registered date:05/10/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Growth hormone deficiency in children
• Date of first enrollment: 16/11/2021
• Target sample size: 24
• Study type: Interventional

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 Outcome: Change in height SDS for chronological age from baseline.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include 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.
• Exclude criteria: A pediatric patient with a diagnosis of diabetes (following the Diagnostic Procedure for Diabetes)

Related Information

• Primary Sponsor: Hasegawa Masahiro