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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-13

Study Completion Date

2034-04-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Growth Hormone Deficiency Neoplasms Diabetes Mellitus Type 2

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with Growth Hormone Deficieny

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.

Somapacitan

Intervention Type DRUG

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

Interventions

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Somapacitan

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

Intervention Type DRUG

Eligibility Criteria

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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.