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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

— Observational Growth Hormone Deficiency Neoplasms Diabetes Mellitus Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Somapacitan.
Who it may be relevant to
Registry conditions: Growth Hormone Deficiency, Neoplasms, Diabetes Mellitus Type 2. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

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

Primary outcome measures

  • Number of adverse drug reactions [Time frame: From baseline (week 0) to end of study (up to 10 years)]
Secondary outcome measures (11)
  • Number of medication errors (incorrect dose administration) [Time frame: From baseline (week 0) to end of study (up to 10 years)]
  • Number of participants with incident neoplasm [Time frame: From baseline (week 0) to end of study (up to 10 years)]
  • Number of participants with incident diabetes mellitus type 2 [Time frame: From baseline (week 0) to end of study (up to 10 years)]
  • Height velocity [Time frame: From baseline (week 0) to end of study (up to 10 years)]
  • Change in height velocity standard deviation score (HVSDS) [Time frame: From baseline (week 0) to end of study (up to 10 years)]
  • Change in height standard deviation score (HSDS) [Time frame: From baseline (week 0) to end of study (up to 10 years)]
  • Change in insulin-like growth factor I (IGF-I) standard deviation score (SDS) [Time frame: From baseline (week 0) to end of study (up to 10 years)]
  • Change in bone age (measured as years) [Time frame: From baseline (week 0) to end of study (up to 10 years)]
  • Change in bone age (measured as months) [Time frame: From baseline (week 0) to end of study (up to 10 years)]
  • Participants reaching near adult height [Time frame: at 10 year]
  • Change in height SDS in participants reaching near adult height [Time frame: From baseline (week 0) to end of study (up to 10 years)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

United Kingdom · 1 center
  • University of Glasgow — Glasgow

Identifiers

NCT: NCT06709040 · NN8640-4787 · U1111-1294-5941

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗