Enrolling By Invitation
OBSERVATIONAL
NCT06109935
Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The purpose of the study is to investigate the safety and effectiveness of Sogroya® in children with short stature due to growth hormone deficiency where epiphysial discs are not closed under real-world clinical practice in Japan. The study will last for about 1 year (at shortest) to 3 years (at longest) depending on when the participant takes part in the study. The participant will be asked to answer questionnaire(s) about how they feel about the growth hormone (GH) product treatment once during the study (at about 3 months after starting the Sogroya® treatment) and about 3 months after starting the Sogroya® treatment.
Interventions
Name:
Somapacitan
Type:
DRUG
Description:
Sogroya® treatment regimen will be in accordance with the approved product labelling in Japan.
Primary Outcomes
Measure:
Number of adverse reactions (AR)
TimeFrame:
From baseline (week 0) to end of study (up to 156 weeks)
Description:
Measured as count of reactions.
Trial Information
NCT ID
NCT06109935
Status
Enrolling By Invitation
Study Type
OBSERVATIONAL
Sponsor
Novo Nordisk A/S
Last Updated
December 15, 2025