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ENROLLING_BY_INVITATION

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

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

NCT06109935•Novo Nordisk A/S

View on ClinicalTrials.gov

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

Age

0 - 18 years

Sex

ALL

Healthy Volunteers

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

Locations (84)

Hoshigaoka Seicho Clinic_Pediatrics

Aichi, Japan

Iwayama Pediatric_Pediatrics

Aichi, Japan

Asai Clinic_Pediatrics

Aichi, Japan

Mutsu general hospital

Aomori, Japan

Asahikawa Medical Univ. Hospital_Pediatrics

Asahikawa, Hokkaido, Japan

Beppu Medical Center

Beppu-shi, Oita-ken, Japan

Inomata Child Clinic_Pediatrics

Chiba, Japan

Seirei Sakura Citizen Hospital_Pediatrics

Chiba, Japan

Kurume University Hospital, Pediatrics

Fukuoka, Japan

Fukuoka University Hospital

Fukuoka-shi, Fukuoka-ken, Japan

Key Dates

Start Date

October 4, 2023

Primary Completion Date

July 31, 2026

Completion Date

July 31, 2026

Last Updated

August 29, 2025

Enrollment

200

ESTIMATED participants

Conditions

Growth Hormone Deficiency in Children

Interventions

Somapacitan

DRUG

A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day.

NCT04970654

Growth Hormone Deficiency in Children

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COMPLETEDPHASE1

First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

NCT01514500

Growth Hormone DisorderAdult Growth Hormone Deficiency+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day.

First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

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Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents

An Observational Study on Treatment Compliance by Children Treated With Growth Hormone