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

Novo Nordisk

Status: Invitation-only

Conditions: Growth Hormone Deficiency in Children

Treatments: Drug: Somapacitan

Study type: Observational

Funder types: Industry

Identifiers

NCT06109935

NN8640-5005

U1111-1274-4223 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No 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

Trial design

200 participants in 1 patient group

Children with GHD

Description:

Participants 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.

Treatment:

Drug: Somapacitan