An extention study of JR-401 in patients with SHOX dificiency

JRCT ID: jRCT2031200425

Registered date:17/03/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: SHOX deficiency
• Date of first enrollment: 02/09/2020
• Target sample size: 19
• Study type: Interventional
• Intervention(s): Administer somatropin (recombinant) subcutaneously at 0.35 mg/kg/week

Outcome(s)

• Primary Outcome: Safety and efficacy during long-term administration

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both
• Include criteria: A pediatric Patient who participated in the previous study and completed the visit after 24 months, and who were judged by the principal-investigator or sub-investigator to be safe for transfer to this study from the viewpoint of safety
• Exclude criteria: A pediatric patient with a diagnosis of diabetes (following the Diagnostic Procedure for Diabetes)

Related Information

• Primary Sponsor: Ibaraki Ryo