Name of study
A non-interventional, observational, register-based study to investigate long-term safety and clinical parameters of somapacitan treatment in children with growth hormone deficiency during routine clinical practice (REAL10)
GloBE-Reg Study ID: 202304_REAL_10
Summary of the proposed work to be performed with the registry data
As part of the risk management plan for Sogroya® (somapacitan) (hereafter only referred to as somapacitan), this non- interventional, observational, register-based study is planned to evaluate long-term safety and clinical parameters of somapacitan treatment in children with growth hormone deficiency in the setting of routine clinical practice.
Lay summary
Somapacitan is a human growth hormone therapy, taken once a week. Following approval by the health authorities, it is required to study the long-term outcomes of somapacitan in a real-world setting. This study will evaluate safety and effectiveness parameters of somapacitan treatment in children with growth hormone deficiency during routine clinical practice
Inclusion criteria
– Treated with commercially available somapacitan according to local practice at the discretion of the physician.
– Primary diagnosis of growth hormone deficiency as per local practice.
– Male or female below 18 years of age at the time of signing informed consent and inclusion in GloBE-Reg
Exclusion criteria
– Patients with active malignancy or in treatment for active pre-existing malignancy
Datafields & Frequency of Collection
GloBE-Reg Core Dataset
GloBE-Reg rhGH Minimum Dataset
Frequency – 6 monthly
Expected outputs
Novo Nordisk plans to use the data to satisfy regulatory requirements from the EMA. This will involve submission of data via a study report to the EMA. Subsequent publications are planned, primarily as a manuscript.
Publication Plan for authorship in outputs
Novo Nordisk intends to drive publications in partnership with GLoBE-Reg investigators. Authors will be invited to co-author publications based on the ICMJE recommendations. Authors will be invited from the Registry users contributing to the dataset
Other Registration Sites
EU PAS Register – Application to be submitted by Novo Nordisk
Date of Approval By GloBE-Reg Data Access Committee 21 April 2023
globe-reg.net 