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

Last updated: August 28, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Enrolling

Phase

N/A

Condition

Severe Short Stature

Growth Hormone Deficiencies/abnormalities

Treatment

Somapacitan

Clinical Study ID

NCT06109935
NN8640-5005
U1111-1274-4223
  • Ages < 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed consent obtained before any study-related activities (study-relatedactivities are any procedure related to recording of data according to theprotocol).

  2. The decision to initiate treatment with commercially available Sogroya® has beenmade by the patient/Legally Acceptable Representative (LAR) and the treatingphysician before and independently from the decision to include the patient in thisstudy. 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 informedconsent.

  4. Diagnosis with short stature due to GHD where epiphysial discs are not closedaccording to local normal clinical practice.

Exclusion

Exclusion Criteria:

  1. Previous participation in this study. Participation is defined as having giveninformed consent in this study.

  2. Treatment with any investigational drug within 30 days prior to baseline (thestarting date of Sogroya® treatment).

  3. Mental incapacity, unwillingness or language barriers precluding adequateunderstanding or cooperation.

  4. Contraindication described in approved product labelling in Japan.

  5. Patients with hypersensitivity to the active substance or to any of theexcipients

  6. Patients with malignant tumour

  7. Female patients who are either pregnant or likely to be pregnant

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: Somapacitan
Phase:
Study Start date:
October 04, 2023
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Asai Clinic_Pediatrics

    Aichi 11192139, 489-0883
    Japan

    Site Not Available

  • Hoshigaoka Seicho Clinic_Pediatrics

    Aichi 11192139, 464-0801
    Japan

    Site Not Available

  • Iwayama Pediatric_Pediatrics

    Aichi 11192139, 468-0049
    Japan

    Site Not Available

  • Mutsu general hospital

    Aomori 2130658, 035-8601
    Japan

    Site Not Available

  • Asahikawa Medical Univ. Hospital, Pediatrics

    Asahikawa, Hokkaido, 078-8510
    Japan

    Site Not Available

  • Asahikawa Medical Univ. Hospital_Pediatrics

    Asahikawa, Hokkaido 2130629, 078-8510
    Japan

    Site Not Available

  • Beppu Medical Center

    Beppu-shi, Oita-ken, 874-0011
    Japan

    Site Not Available

  • Inomata Child Clinic_Pediatrics

    Chiba 2113015, 273-0002
    Japan

    Site Not Available

  • Seirei Sakura Citizen Hospital_Pediatrics

    Chiba 2113015, 285-8765
    Japan

    Site Not Available

  • Kurume University Hospital, Pediatrics

    Fukuoka, 830-0011
    Japan

    Site Not Available

  • Kurume University Hospital, Pediatrics

    Fukuoka 1863967, 830-0011
    Japan

    Site Not Available

  • Kyushu University Hospital

    Fukuoka-shi, Fukuoka, 812-8582
    Japan

    Site Not Available

  • Fukuoka University Hospital

    Fukuoka-shi, Fukuoka-ken, 814-0133
    Japan

    Site Not Available

  • Fukuoka University Hospital

    Fukuoka-shi, Fukuoka-ken 1863967, 814-0133
    Japan

    Site Not Available

  • Gifu University Hospital

    Gifu, 501-1194
    Japan

    Site Not Available

  • Gifu University Hospital

    Gifu 1863641, 501-1194
    Japan

    Site Not Available

  • Ota Memorial Hospital_Pediatrics

    Gunma, 373-8585
    Japan

    Site Not Available

  • Kato Clinic

    Hachioji-shi, Tokyo-to, 192-0919
    Japan

    Site Not Available

  • Hamamatsu University Hospital

    Hamamatsu-shi, Shizuoka, 431-3192
    Japan

    Site Not Available

  • Hello Clinic

    Higashimatsuyama-shi, Saitama-ken, 355-0008
    Japan

    Site Not Available

  • Japanese Red Cross Society Himeji Hospital

    Himeji-shi, Hyogo-ken, 670-0063
    Japan

    Site Not Available

  • Yonekura Child Clinic_Pediatrics

    Hiroshima 1862415, 737-0046
    Japan

    Site Not Available

  • Hyogo prefectural kobe children's hospital

    Hyogo, 654-0047
    Japan

    Site Not Available

  • Hyogo prefectural kobe children's hospital

    Hyōgo 2129969, 654-0047
    Japan

    Site Not Available

  • Nagai Kids Clinic_Pediatrics

    Hyōgo 2129969, 665-0842
    Japan

    Site Not Available

  • Nakasako Kids Clinic_Pediatrics

    Hyōgo 2129969, 657-0028
    Japan

    Site Not Available

  • Sunsun Kodomo Clinic

    Ichikawa-shi, Chiba-ken, 272-0023
    Japan

    Site Not Available

  • Komatsu Municipal Hospital_Pediatrics

    Ishikawa 1861393, 923-8560
    Japan

    Site Not Available

  • Fukushima Seishi Ryougoen

    Iwaki-shi, Fukushima-ken, 970-8001
    Japan

    Site Not Available

  • Fukushima Seishi Ryougoen

    Iwaki-shi, Fukushima-ken 2112539, 970-8001
    Japan

    Site Not Available

  • Iwate Medical University Hospital

    Iwate, 028-3695
    Japan

    Site Not Available

  • Shimane University Hospital_Pediatrics

    Izumo-shi, Shimane-ken, 693-0021
    Japan

    Site Not Available

  • Kagoshima University hospital_Pediatrics

    Kagoshima 1860827, 890-8520
    Japan

    Site Not Available

  • University Hospital Kyoto Prefectual University of Medicine

    Kamigyo-ku, Kyoto, 602-8566
    Japan

    Site Not Available

  • Odawara Municipal Hospital

    Kanagawa, 250-8558
    Japan

    Site Not Available

  • Hanamaru Kids Clinic_Pediatrics

    Kanagawa 1860292, 227-0043
    Japan

    Site Not Available

  • Muza Kawasaki Pediatric Clinic_Pediatrics

    Kanagawa 1860292, 212-0014
    Japan

    Site Not Available

  • Odawara Municipal Hospital_Diabetes and Endocrinology

    Kanagawa 1860292, 250-8558
    Japan

    Site Not Available

  • Oguchi Higashi Hospital_Pediatrics

    Kanagawa 1860292, 221-0014
    Japan

    Site Not Available

  • Nippon Medical School Musashikosugi Hospital

    Kawasaki-shi, Kanagawa-ken, 211-0063
    Japan

    Site Not Available

  • Nippon Medical School Musashikosugi Hospital_Neurological Surgery

    Kawasaki-shi, Kanagawa-ken, 211-0063
    Japan

    Site Not Available

  • Hospital of the University of Occupational And Environmental Health Japan, Pediatrics

    Kitakyusyu-shi, Fukuoka, 807 8555
    Japan

    Site Not Available

  • Hospital of the University of Occupational And Environmental Health Japan, Pediatrics

    Kitakyusyu-shi, Fukuoka 1863967, 807 8555
    Japan

    Site Not Available

  • Mominoki Hospital, Pediatrics

    Kochi-shi, Kochi, 780 0952
    Japan

    Site Not Available

  • Kumamoto University Hospital, Pediatrics

    Kumamoto-shi, Kumamoto, 860 8556
    Japan

    Site Not Available

  • Ayabe City Hospital

    Kyoto, 623-0011
    Japan

    Site Not Available

  • Ayabe City Hospital

    Kyoto 1857910, 623-0011
    Japan

    Site Not Available

  • University of Miyazaki Hospital_Pediatrics

    Miyazaki 1856717, 889-1692
    Japan

    Site Not Available

  • Haga Red Cross Hospital

    Moka-shi, Tochigi-ken, 321-4308
    Japan

    Site Not Available

  • Kodomohamirai Morioka Kodomo Clinic

    Morioka-shi, Iwate-ken, 020-0102
    Japan

    Site Not Available

  • Kodomohamirai Morioka Kodomo Clinic

    Morioka-shi, Iwate-ken 2111834, 020-0102
    Japan

    Site Not Available

  • Aichi Medical University Hospital

    Nagakute-shi, Aichi 11192139, 480-1195
    Japan

    Site Not Available

  • Ina Central Hospital_Nagano

    Nagano 1856215, 396-0033
    Japan

    Site Not Available

  • Nagasaki University Hospital_Pediatrics

    Nagasaki 1856177, 852-8501
    Japan

    Site Not Available

  • Nagoya City University Hospital, Pediatric

    Nagoya, Aichi, 467-8602
    Japan

    Site Not Available

  • Naha City Hospital

    Naha-shi, Okinawa, 902-8511
    Japan

    Site Not Available

  • University of the Ryukyus Hospital

    Nakagami-gun, Okinawa-ken, 903-0125
    Japan

    Site Not Available

  • Nara Medical University Hospital_Pediatrics

    Nara, 634-8522
    Japan

    Site Not Available

  • Nara Medical University Hospital_Pediatrics

    Nara 1855612, 634-8522
    Japan

    Site Not Available

  • Nara Prefecture General Medical Center

    Nara-shi, Nara, 630-8581
    Japan

    Site Not Available

  • Niigata University Medical & Dental Hospital_Pediatrics

    Niigata-shi, Niigata, 951 8520
    Japan

    Site Not Available

  • Hyogo Medical University Hospital_Pediatrics

    Nishinomiya-shi, Hyogo-ken, 663-8131
    Japan

    Site Not Available

  • Iwate Medical University Hospital

    Numakunai 2111574, 028-3695
    Japan

    Site Not Available

  • Aichi Children's Health and Medical Center

    Obu-shi, Aichi, 474-8710
    Japan

    Site Not Available

  • Aichi Children's Health and Medical Center

    Obu-shi, Aichi 11192139, 474-8710
    Japan

    Site Not Available

  • Asahigawasou Ryouiku Iryou Center_Pediatrics

    Okayama 1854383, 703-8555
    Japan

    Site Not Available

  • Okayama University Hospital_Pediatrics

    Okayama 1854383, 700-8558
    Japan

    Site Not Available

  • Chibana Clinic

    Okinawa, 904-2143
    Japan

    Site Not Available

  • Chibana Clinic

    Okinawa 1894616, 904-2143
    Japan

    Site Not Available

  • Kibounomori Clinic

    Oosakashi, 540-0003
    Japan

    Site Not Available

  • Osaka City General Hospital

    Osaka, 534-0021
    Japan

    Site Not Available

  • Osaka University Hospital

    Osaka, 565-0871
    Japan

    Site Not Available

  • Osaka Women's and Children's Hospital

    Osaka, 594-1101
    Japan

    Site Not Available

  • Saiseikai Suita Hospital

    Osaka, 564-0013
    Japan

    Site Not Available

  • Yasuhara Children's Clinic

    Osaka, 572-0085
    Japan

    Site Not Available

  • JCHO Osaka Hospital_Pediatric

    Osaka 1853909, 553-0003
    Japan

    Site Not Available

  • Kibounomori Clinic

    Osaka 1853909, 540-0003
    Japan

    Site Not Available

  • Osaka City General Hospital_Endocrinology and Diabetes Mellitus

    Osaka 1853909, 534-0021
    Japan

    Site Not Available

  • Osaka University Hospital

    Osaka 1853909, 565-0871
    Japan

    Site Not Available

  • Osaka Women's and Children's Hospital

    Osaka 1853909, 594-1101
    Japan

    Site Not Available

  • Saiseikai Suita Hospital

    Osaka 1853909, 564-0013
    Japan

    Site Not Available

  • Yasuhara Children's Clinic

    Osaka 1853909, 572-0085
    Japan

    Site Not Available

  • Kojiya Kodomo clinic

    Ota-ku, Tokyo-to, 144-0034
    Japan

    Site Not Available

  • Kojiya Kodomo clinic

    Ota-ku, Tokyo-to 8469289, 144-0034
    Japan

    Site Not Available

  • Okubo Kids Clinic

    Ozu-shi, Ehime-ken, 795-0061
    Japan

    Site Not Available

  • Clinic for Children and Youths_Pediatrics

    Saitama 6940394, 336-0967
    Japan

    Site Not Available

  • Sakai Smile Kids Clinic

    Sashima-gun, Ibaraki-ken, 306-0434
    Japan

    Site Not Available

  • JR Sendai Hospital

    Sendai-shi, Miyagi-ken, 980-0022
    Japan

    Site Not Available

  • JR Sendai Hospital

    Sendai-shi, Miyagi-ken 2111149, 980-0022
    Japan

    Site Not Available

  • Shiga General Hospital_Diabetes and Endocrinology

    Shiga 9115498, 524-0022
    Japan

    Site Not Available

  • Shiga university of Medical Science Hospital_Pediatrics

    Shiga 9115498, 520-2192
    Japan

    Site Not Available

  • Hamamatsu Medical Center

    Shizuoka, 432-8580
    Japan

    Site Not Available

  • Hamamatsu Medical Center

    Shizuoka 1851717, 432-8580
    Japan

    Site Not Available

  • Iwata City Hospital_Pediatrics

    Shizuoka 1851717, 438-8550
    Japan

    Site Not Available

  • My Clinic Ohkubo

    Shizuoka 1851717, 420-0923
    Japan

    Site Not Available

  • Shizuoka Saiseikai General Hospital_Pediatrics

    Shizuoka 1851717, 422-8527
    Japan

    Site Not Available

  • Shizuoka Children's Hospital, Department of Diabetes and metabolism

    Shizuoka-shi, Shizuoka, 420-8660
    Japan

    Site Not Available

  • Novo Nordisk Investigational Site

    Tokyo, 158-0097
    Japan

    Active - Recruiting

  • Tanaka Growth Clinic

    Tokyo, 158-0097
    Japan

    Site Not Available

  • Akiruno Clinic_Pediatrics

    Tokyo 1850147, 197-0802
    Japan

    Site Not Available

  • National Center for Child Health and Dev, Endo and Metabo

    Tokyo 1850147, 157 8535
    Japan

    Site Not Available

  • Sakura Kids Clinic_Pediatrics

    Tokyo 1850147, 154-0015
    Japan

    Site Not Available

  • Tanaka Growth Clinic

    Tokyo 1850147, 158-0097
    Japan

    Site Not Available

  • Ehime University Hospital

    Toon-shi, Ehime, 791-0295
    Japan

    Site Not Available

  • Murakami Pediatric and Allergy clinic

    Toyama-shi, Toyama-ken, 930-0827
    Japan

    Site Not Available

  • Murakami Pediatric and Allergy clinic

    Toyama-shi, Toyama-ken 1849876, 930-0827
    Japan

    Site Not Available

  • Fujita Health University Hospital, Pediatrics

    Toyoake, Aichi, 470-1192
    Japan

    Site Not Available

  • Toyohashi Municipal Hospital

    Toyohashi-shi, Aichi-ken, 441-8085
    Japan

    Site Not Available

  • Toyohashi Municipal Hospital

    Toyohashi-shi, Aichi-ken 1849846, 441-8085
    Japan

    Site Not Available

  • Tendo City Hospital_Pediatrics

    Yamagata 2110556, 994-0047
    Japan

    Site Not Available

  • Ikeda Pediatrics Clinic

    Yamagata-shi, Yamagata-ken, 990-2313
    Japan

    Site Not Available

  • Ikeda Pediatrics Clinic

    Yamagata-shi, Yamagata-ken 2110556, 990-2313
    Japan

    Site Not Available

  • Yamaguchi University Hospital_Pediatrics

    Yamaguchi 1848689, 755-8505
    Japan

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.