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
- Conditions
- Growth Hormone Deficiency in Children
- Registration Number
- NCT06109935
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria:<br><br> 1. Signed consent obtained before any study-related activities (study-related<br> activities are any procedure related to recording of data according to the<br> protocol).<br><br> 2. The decision to initiate treatment with commercially available Sogroya® has been<br> made by the patient/Legally Acceptable Representative (LAR) and the treating<br> physician before and independently from the decision to include the patient in this<br> study. Both GH treatment naïve and non-naïve children are eligible.<br><br> 3. Male or female age 0 to 18 years (exclusive) at the time of signing informed<br> consent.<br><br> 4. Diagnosis with short stature due to GHD where epiphysial discs are not closed<br> according to local normal clinical practice.<br><br>Exclusion Criteria:<br><br> 1. Previous participation in this study. Participation is defined as having given<br> informed consent in this study.<br><br> 2. Treatment with any investigational drug within 30 days prior to baseline (the<br> starting date of Sogroya® treatment).<br><br> 3. Mental incapacity, unwillingness or language barriers precluding adequate<br> understanding or cooperation.<br><br> 4. Contraindication described in approved product labelling in Japan.<br><br> 1. Patients with hypersensitivity to the active substance or to any of the<br> excipients<br><br> 2. Patients with malignant tumour<br><br> 3. Female patients who are either pregnant or likely to be pregnant
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of adverse reactions (AR)
- Secondary Outcome Measures
Name Time Method Number of adverse events (AEs);Number of serious adverse events (SAEs);Number of serious adverse reactions (SARs);Change in height velocity (HV);Change in bone age;Change in ratio of bone age/chronological age;Change in height standard deviation score (HSDS);Change in height velocity standard deviation score (HVSDS);Change in insulin-like growth factor-I standard deviation score (IGF-I SDS);Growth hormone device assessment tool (G-DAT);Growth hormone patient preference questionnaire (GH-PPQ)