DRUG
Somapacitan
Participants will be treated with commercially available somapacitan according to routine clinical practice at the discretion of the treating physician.
A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters
Status
Enrolling by invitation
Phase
Not applicable
Enrollment
500
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Treatment arms and agents.
Timeline
From registration to results.
First posted
Nov 29, 2024
Study start
Dec 13, 2024
Primary completion
Apr 14, 2034
Study completion
Apr 14, 2034
Results posted
Not reported
Registry updated
Apr 6, 2026
Outcomes
What the study measures.
Primary outcomes
Number of adverse drug reactions
Time frame · From baseline (week 0) to end of study (up to 10 years)
Measured as count of events.
Secondary outcomes
Number of medication errors (incorrect dose administration)
Time frame · From baseline (week 0) to end of study (up to 10 years)
Measured as count of errors.
Number of participants with incident neoplasm
Time frame · From baseline (week 0) to end of study (up to 10 years)
Measured as number of participants (yes/no).
Number of participants with incident diabetes mellitus type 2
Time frame · From baseline (week 0) to end of study (up to 10 years)
Measured as number of participants (yes/no).
Height velocity
Time frame · From baseline (week 0) to end of study (up to 10 years)
measured as centimeter per year (cm/year).
Change in height velocity standard deviation score (HVSDS)
Time frame · From baseline (week 0) to end of study (up to 10 years)
Measured as score ranging from -10 to +10.
Change in height standard deviation score (HSDS)
Time frame · From baseline (week 0) to end of study (up to 10 years)
Measured as score ranging from -10 to +10.
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)
Measured as score ranging from -10 to +10.
Change in bone age (measured as years)
Time frame · From baseline (week 0) to end of study (up to 10 years)
Measured as years.
Change in bone age (measured as months)
Time frame · From baseline (week 0) to end of study (up to 10 years)
Measured as months.
Participants reaching near adult height
Time frame · at 10 year
Near adult height defined as: height velocity \<2 cm/year over the last 9 months and chronological age \>16 years (males) or \>15 years (females) or bone age \>16 years (males) and \> 15 years (females). Measured as number of participants (yes/no). Only for those who are expected to reach near adult height during the study.
Eligibility
Who can take part.
- Minimum age
- Not reported
- Maximum age
- 18 Years
- Sex
- ALL
- Healthy volunteers
- Not reported
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.
Study locations
1 registered sites.
United Kingdom. Showing up to 24 locations stored in the fast local snapshot.
University of Glasgow
Glasgow, Scotland, United Kingdom
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.