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

Launched by NOVO NORDISK A/S · Oct 25, 2023

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
• • 2. 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.
• • 3. Male or female age 0 to 18 years (exclusive) at the time of signing informed consent.
• • 4. Diagnosis with short stature due to GHD where epiphysial discs are not closed according to local normal clinical practice.
• Exclusion Criteria:
• • 1. Previous participation in this study. Participation is defined as having given informed consent in this study.
• • 2. Treatment with any investigational drug within 30 days prior to baseline (the starting date of Sogroya® treatment).
• • 3. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
• • 4. Contraindication described in approved product labelling in Japan.
• • 1. Patients with hypersensitivity to the active substance or to any of the excipients
• • 2. Patients with malignant tumour
• • 3. Female patients who are either pregnant or likely to be pregnant