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Growth Hormone Deficiency in ChildrenNCT06109935

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

An observational study of Growth Hormone Deficiency in Children, run by Novo Nordisk A/S at 86 sites in Japan.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 0 to 18 years
Conditions the study is for
Growth Hormone Deficiency in Children
What is being tested?
Somapacitan
How many people
200 participants
Where
86 sitesJapan
Study dates
4 Oct 2023to 31 Dec 2026
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Children with short stature due to Growth Hormone Deficiency (GHD) where epiphysial discs are not closed under normal clinical practice conditions in Japan.

Who may be able to join

  • 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.

Who cannot join

  • 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.
  • Patients with hypersensitivity to the active substance or to any of the excipients
  • Patients with malignant tumour
  • Female patients who are either pregnant or likely to be pregnant

Trial locations and contacts

86 sites in 1 country. Contact the study team or a site near you to ask about taking part.

86 sites in 1 country

Japan86 sites

  • Hoshigaoka Seicho Clinic_Pediatrics

    Aichi, 464-0801

  • Iwayama Pediatric_Pediatrics

    Aichi, 468-0049

  • Asai Clinic_Pediatrics

    Aichi, 489-0883

  • Mutsu general hospital_Pediatrics

    Aomori, 035-8601

  • Asahikawa Medical Univ. Hospital_Pediatrics

    Asahikawa, Hokkaido, 078-8510

  • Beppu Medical Center

    Beppu-shi, Oita-ken, 874-0011

  • Inomata Child Clinic_Pediatrics

    Chiba, 273-0002

  • Seirei Sakura Citizen Hospital_Pediatrics

    Chiba, 285-8765

  • Kurume University Hospital, Pediatrics

    Fukuoka, 830-0011

  • Kyushu University Hospital_Endocrine Metab Diab inter med

    Fukuoka-shi, Fukuoka, 812-8582

  • Fukuoka University Hospital

    Fukuoka-shi, Fukuoka-ken, 814-0133

  • Gifu University Hospital_The Third Dept. of Internal Medicine

    Gifu, 501-1194

  • Ota Memorial Hospital_Pediatrics

    Gunma, 373-8585

  • Kato Clinic

    Hachioji-shi, Tokyo-to, 192-0919

  • Hamamatsu University Hospital_Liver Internal Medicine

    Hamamatsu-shi, Shizuoka, 431-3192

  • Hello Clinic

    Higashimatsuyama-shi, Saitama-ken, 355-0008

  • Japanese Red Cross Society Himeji Hospital

    Himeji-shi, Hyogo-ken, 670-0063

  • Yonekura Child Clinic_Pediatrics

    Hiroshima, 737-0046

  • Hyogo prefectural kobe children's hospital Dept. of Haem and Onclogy

    Hyōgo, 654-0047

  • Nakasako Kids Clinic_Pediatrics

    Hyōgo, 657-0028

  • Nagai Kids Clinic_Pediatrics

    Hyōgo, 665-0842

  • Sunsun Kodomo Clinic

    Ichikawa-shi, Chiba-ken, 272-0023

  • Komatsu Municipal Hospital_Pediatrics

    Ishikawa, 923-8560

  • Fukushima Seishi Ryougoen

    Iwaki-shi, Fukushima-ken, 970-8001

  • Shimane University Hospital_Pediatrics

    Izumo-shi, Shimane-ken, 693-0021

  • Kagoshima University hospital_Pediatrics

    Kagoshima, 890-8520

  • University Hospital Kyoto Prefectual University of Medicine

    Kamigyo-ku, Kyoto, 602-8566

  • Muza Kawasaki Pediatric Clinic_Pediatrics

    Kanagawa, 212-0014

  • Oguchi Higashi Hospital_Pediatrics

    Kanagawa, 221-0014

  • Hanamaru Kids Clinic_Pediatrics

    Kanagawa, 227-0043

  • Odawara Municipal Hospital_Diabetes and Endocrinology

    Kanagawa, 250-8558

  • Nippon Medical School Musashikosugi Hospital_Neurological Surgery

    Kawasaki-shi, Kanagawa-ken, 211-0063

  • Hospital of the University of Occupational And Environmental Health Japan_Pediatrics

    Kitakyusyu-shi, Fukuoka, 807 8555

  • Mominoki Hospital, Pediatrics

    Kochi-shi, Kochi, 780 0952

  • Kumamoto University Hospital, Pediatrics

    Kumamoto-shi, Kumamoto, 860 8556

  • Ayabe City Hospital_Endocrinology and Diabetes

    Kyoto, 623-0011

  • University of Miyazaki Hospital_Pediatrics

    Miyazaki, 889-1692

  • Haga Red Cross Hospital

    Moka-shi, Tochigi-ken, 321-4308

  • Kodomohamirai Morioka Kodomo Clinic

    Morioka-shi, Iwate-ken, 020-0102

  • Aichi Medical University Hospital_Hepatology and pancreology

    Nagakute-shi, Aichi, 480-1195

  • Ina Central Hospital_Internal Medicine

    Nagano, 396-0033

  • Nagasaki University Hospital_Pediatrics

    Nagasaki, 852-8501

  • Nagoya City University Hospital, Pediatric

    Nagoya, Aichi, 467-8602

  • Naha City Hospital_Cardiovascular Medicine

    Naha-shi, Okinawa, 902-8511

  • University of the Ryukyus Hospital

    Nakagami-gun, Okinawa-ken, 903-0125

  • Nara Medical University Hospital_Pediatrics

    Nara, 634-8522

  • Nara Prefecture General Medical Center_Nephrology

    Nara-shi, Nara, 630-8581

  • Niigata University Medical & Dental Hospital_Pediatrics

    Niigata-shi, Niigata, 951 8520

  • Hyogo Medical University Hospital_Pediatrics

    Nishinomiya-shi, Hyogo-ken, 663-8131

  • Iwate Medical University Hospital_Diabetes and Metabolism

    Numakunai, 028-3695

  • Aichi Children's Health and Medical Center

    Obu-shi, Aichi, 474-8710

  • Okayama University Hospital_Pediatrics

    Okayama, 700-8558

  • Asahigawasou Ryouiku Iryou Center_Pediatrics

    Okayama, 703-8555

  • Chibana Clinic

    Okinawa, 904-2143

  • Osaka City General Hospital

    Osaka, 534-0021

  • Kibounomori Clinic

    Osaka, 540-0003

  • JCHO Osaka Hospital_Pediatric

    Osaka, 553-0003

  • Saiseikai Suita Hospital_Metabolism and Diabetes Intern

    Osaka, 564-0013

  • The University of Osaka Hospital_Metabolic Medicine

    Osaka, 565-0871

  • Yasuhara Children's Clinic

    Osaka, 572-0085

  • Osaka Women's and Children's Hospital

    Osaka, 594-1101

  • Kojiya Kodomo clinic

    Ota-ku, Tokyo-to, 144-0034

  • Okubo Kids Clinic

    Ozu-shi, Ehime-ken, 795-0061

  • Clinic for Children and Youths_Pediatrics

    Saitama, 336-0967

  • Sakai Smile Kids Clinic

    Sashima-gun, Ibaraki-ken, 306-0434

  • JR Sendai Hospital

    Sendai-shi, Miyagi-ken, 980-0022

  • Shiga university of Medical Science Hospital_Pediatrics

    Shiga, 520-2192

  • Shiga General Hospital_Diabetes and Endocrinology

    Shiga, 524-0022

  • My Clinic Ohkubo

    Shizuoka, 420-0923

  • Shizuoka Saiseikai General Hospital_Pediatrics

    Shizuoka, 422-8527

  • Hamamatsu Medical Center_Endocrinology and Metabolism

    Shizuoka, 432-8580

  • Iwata City Hospital_Pediatrics

    Shizuoka, 438-8550

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

    Shizuoka-shi, Shizuoka, 420-8660

  • Tokushima University Hospital_Pediatrics

    Tokushima, 770-8503

  • Sakura Kids Clinic_Pediatrics

    Tokyo, 154-0015

  • National Center for Child Health and Development_Endo and Metabo

    Tokyo, 157 8535

  • Tanaka Growth Clinic

    Tokyo, 158-0097

  • Kyorin University Hospital_Pediatrics

    Tokyo, 181-0004

  • Akiruno Clinic_Pediatrics

    Tokyo, 197-0802

  • Ehime University Hospital_Department of Gastro.& Metabo.

    Toon-shi, Ehime, 791-0295

  • Murakami Pediatric and Allergy clinic

    Toyama-shi, Toyama-ken, 930-0827

  • Fujita Health University Hospital, Pediatrics

    Toyoake, Aichi, 470-1192

  • Toyohashi Municipal Hospital

    Toyohashi-shi, Aichi-ken, 441-8085

  • Tendo City Hospital_Pediatrics

    Yamagata, 994-0047

  • Ikeda Pediatrics Clinic

    Yamagata-shi, Yamagata-ken, 990-2313

  • Yamaguchi University Hospital_Pediatrics

    Yamaguchi, 755-8505

Other trials in Japan

About this study

Official title: 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.

Being tested
Somapacitan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SomapacitanDrug

    Also called Sogroya®

    Sogroya® treatment regimen will be in accordance with the approved product labelling in Japan.

Study groups in NCT06109935
Study groupRoleWhat they receive
Children with GHDParticipants will be treated with commercially available Sogroya® according to routine clinical practice at the discretion of the treating physician. Administration will be according to the approved product labelling. The decision to treat a participant with Sogroya® is made at the treating physician's discretion before and independently from the decision to include the patient in this study.
Receives: Drug: Somapacitan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of adverse reactions (AR)

    Measured as count of reactions.

    Measured: From baseline (week 0) to end of study (up to 156 weeks)

Secondary outcomes (11)

  1. Number of adverse events (AEs)

    Measured as count of events.

    Measured: From baseline (week 0) to end of study (up to 156 weeks)

  2. Number of serious adverse events (SAEs)

    Measured as count of events.

    Measured: From baseline (week 0) to end of study (up to 156 weeks)

  3. Number of serious adverse reactions (SARs)

    Measured as count of reactions.

    Measured: From baseline (week 0) to end of study (up to 156 weeks)

  4. Change in height velocity (HV)

    Measured in centimeter (cm)/year.

    Measured: Every 12 months from baseline (week 0) to end of study (up to 156 weeks)

  5. Change in bone age

    Measured in years.

    Measured: Every 12 months from baseline (week 0) to end of study (up to 156 weeks)

  6. Change in ratio of bone age/chronological age

    Measured: Every 12 months from baseline (week 0) to end of study (up to 156 weeks)

  7. Change in height standard deviation score (HSDS)

    Measured: Every 12 months from baseline (week 0) to end of study (up to 156 weeks)

  8. Change in height velocity standard deviation score (HVSDS)

    Measured: Every 12 months from baseline (week 0) to end of study (up to 156 weeks)

  9. Change in insulin-like growth factor-I standard deviation score (IGF-I SDS)

    Measured as score ranging from -10 to +10. Negative scores indicated a IGF-I below the mean IGF-I for a child with the same age and gender, whereas positive scores indicated a IGF-I above the mean IGF-I for a child with the same age and gender. For participants with low IGF-I SDS at baseline, a positive change from baseline in IGF-I SDS indicated a better outcome.

    Measured: Every 12 months from baseline (week 0) to end of study (up to 156 weeks)

  10. Growth hormone device assessment tool (G-DAT)

    Measured as count of patients choosing the individual response category. G-DAT is a questionnaire to gather information on how they feel about the GH product device assessed as "very easy", "easy", "neither difficult or easy", "difficult" or "very difficult" where "very easy" is best and "very difficult" is worst.

    Measured: At 12 weeks

  11. Growth hormone patient preference questionnaire (GH-PPQ)

    Measured as count of patients choosing the individual response category. GH-PPQ is a disease specific questionnaire which measures the patient's growth hormone treatment preference.

    Measured: At 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2023
  2. Study start4 Oct 2023
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06109935
Sponsor's protocol ID
NN8640-5005
Other IDs
U1111-1274-4223
Status last verified
Apr 2026
First submitted
25 Oct 2023
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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