NN8640-4787 A Non-interventional, Observational, Registry-based Study to Investigate Long-term Safety and Clinical Parameters of Somapacitan Treatment in Paediatric Patients With Growth Hormone Deficiency During Routine Clinical Practice

Study identification

• EU PAS number:
  EUPAS1000000602
• Study ID:
  1000000602
• Official title and acronym:
  NN8640-4787 A Non-interventional, Observational, Registry-based Study to Investigate Long-term Safety and Clinical Parameters of Somapacitan Treatment in Paediatric Patients With Growth Hormone Deficiency During Routine Clinical Practice
• DARWIN EU® study:
  No
• Study countries:
  Germany

  Saudi Arabia

  Slovenia

  United States
• Study description:
  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 at least 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.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Novo Nordisk

Study timelines

Date when funding contract was signed

Planned:13/09/2023

Study start date

Planned:13/12/2024

Actual:13/12/2024

Date of final study report

Planned:20/09/2035

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novo Nordisk A/S

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)