Status:
ENROLLING_BY_INVITATION
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
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Growth Hormone Deficiency in Children
Eligibility:
All Genders
Up to 18 years
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-wor...
Eligibility Criteria
Inclusion
- Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
- The decision to initiate treatment with commercially available Sogroya® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study. Both GH treatment naïve and non-naïve children are eligible.
- Male or female age 0 to 18 years (exclusive) at the time of signing informed consent.
- Diagnosis with short stature due to GHD where epiphysial discs are not closed according to local normal clinical practice.
Exclusion
- Previous participation in this study. Participation is defined as having given informed consent in this study.
- Treatment with any investigational drug within 30 days prior to baseline (the starting date of Sogroya® treatment).
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Contraindication described in approved product labelling in Japan.
- Patients with hypersensitivity to the active substance or to any of the excipients
- Patients with malignant tumour
- Female patients who are either pregnant or likely to be pregnant
Key Trial Info
Start Date :
October 4 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06109935
Start Date
October 4 2023
End Date
July 31 2026
Last Update
August 29 2025
Active Locations (84)
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1
Hoshigaoka Seicho Clinic_Pediatrics
Aichi, Japan, 464-0801
2
Iwayama Pediatric_Pediatrics
Aichi, Japan, 468-0049
3
Asai Clinic_Pediatrics
Aichi, Japan, 489-0883
4
Mutsu general hospital
Aomori, Japan, 035-8601