Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-24 @ 10:33 PM
NCT ID:
NCT06109935
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Years
Maximum Age:
18 Years
Study:
NCT06109935
Study Brief:
Protocol Section:
NCT06109935