By InvitationNot Applicable

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

United Kingdom500 participantsStarted 2024-12-13

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

Number of adverse drug reactions

Timeframe: From baseline (week 0) to end of study (up to 10 years)

Trial details

NCT IDNCT06709040

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2034-04-14

View on ClinicalTrials.gov More Growth Hormone Deficiency trials