A Multi-centre, Prospective, Open Label, Single-arm, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Sogroya® Treatment in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed Under Normal Clinical Practice Conditions in Japan Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency (GHD) Where Epiphysial Discs Are Not Closed
A Multi-centre, Prospective, Open Label, Single-arm, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Sogroya® Treatment in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed Under Normal Clinical Practice Conditions in Japan Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency (GHD) Where Epiphysial Discs Are Not Closed
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.
Inclusion Criteria:
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.
Contraindication described in approved product labelling in Japan.
Beppu-shi, Oita-ken, 874-0011, Japan
Fukuoka-shi, Fukuoka, 812-8582, Japan
Gunma, 373-8585, Japan
Hachioji-shi, Tokyo-to, 192-0919, Japan
Hamamatsu-shi, Shizuoka, 431-3192, Japan
Higashimatsuyama-shi, Saitama-ken, 355-0008, Japan
Himeji-shi, Hyogo-ken, 670-0063, Japan
Ichikawa-shi, Chiba-ken, 272-0023, Japan
Izumo-shi, Shimane-ken, 693-0021, Japan
Kamigyo-ku, Kyoto, 602-8566, Japan
Kawasaki-shi, Kanagawa-ken, 211-0063, Japan
Kitakyusyu-shi, Fukuoka, 807 8555, Japan
Kochi-shi, Kochi, 780 0952, Japan
Kumamoto-shi, Kumamoto, 860 8556, Japan
Moka-shi, Tochigi-ken, 321-4308, Japan
Nagoya, Aichi, 467-8602, Japan
Naha-shi, Okinawa, 902-8511, Japan
Nakagami-gun, Okinawa-ken, 903-0125, Japan
Nara-shi, Nara, 630-8581, Japan
Niigata-shi, Niigata, 951 8520, Japan
Nishinomiya-shi, Hyogo-ken, 663-8131, Japan
Ozu-shi, Ehime-ken, 795-0061, Japan
Sashima-gun, Ibaraki-ken, 306-0434, Japan
Shizuoka-shi, Shizuoka, 420-8660, Japan
Toon-shi, Ehime, 791-0295, Japan
Toyoake, Aichi, 470-1192, Japan