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ENROLLING BY INVITATION
NCT06709040

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

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

Any - 18 Years

Study Type

OBSERVATIONAL

Enrollment

500

Start Date

2024-12-13

Completion Date

2034-04-14

Last Updated

2026-04-06

Healthy Volunteers

Not specified

Interventions

DRUG

Somapacitan

Participants will be treated with commercially available somapacitan according to routine clinical practice at the discretion of the treating physician.

Locations (1)

University of Glasgow

Glasgow, Scotland, United Kingdom