A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters

Novo Nordisk

Status: Invitation-only

Conditions: Neoplasms; Diabetes Mellitus Type 2; Growth Hormone Deficiency

Treatments: Drug: Somapacitan

Study type: Observational

Funder types: Industry

Identifiers

NCT06709040

NN8640-4787

U1111-1294-5941 (Other Identifier)

Details and patient eligibility

About

The aim of this study is to look at the long-term safety and clinical parameters of somapacitan in paediatric participants with growth hormone deficiency under routine clinical practice conditions. The study population will include 400 paediatric growth hormone deficient participants from the Global Registry for Novel Therapies in Rare Bone and Endocrine Conditions (GloBE-Reg) treated with once-weekly somapacitan and fulfilling the eligibility criteria of the study. The total duration of the study is planned to 10 years consisting of a 5-year recruitment period in the GLoBE-Reg followed by a 5-year follow-up period.

Enrollment: 500 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treated with commercially available somapacitan according to local practice at the discretion of the physician.
• Primary confirmed diagnosis of growth hormone deficiency as per local practice.
• Male or female below 18 years of age at the time of signing informed consent in the GLoBE-Reg.

Exclusion criteria

• Participants with active malignancy or in treatment for active pre-existing malignancy.

Trial design

500 participants in 1 patient group

Participants with Growth Hormone Deficieny

Description:

The study is non-interventional as there are no interventions involved and decision to treat participants with commerically available somapacitan will be made at the treating physician's discretion prior to, and independently from, the decision to include the participants in the GLoBE-Reg registry. Novo Nordisk will not provide any products for included participants during the conduct of the study.

Treatment:

Drug: Somapacitan