Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due … (NCT06109935) | Clinical Trial Compass
By InvitationNot Applicable
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
Japan200 participantsStarted 2023-10-04
Plain-language 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.
Who can participate
Age range0 Years – 18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Number of adverse reactions (AR)
Timeframe: From baseline (week 0) to end of study (up to 156 weeks)