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

N/AEnrolling By InvitationNCT06109935

Novo Nordisk A/S200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Growth Hormone Deficiency in Children

Interventions

SomapacitanDRUG

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

Eligibility

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of adverse reactions (AR)

Measured as count of reactions.

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

Secondary Outcomes

Number of adverse events (AEs)

Measured as count of events.

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

Number of serious adverse events (SAEs)

Measured as count of events.

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

Number of serious adverse reactions (SARs)

Measured as count of reactions.

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

Change in height velocity (HV)

Measured in centimeter (cm)/year.