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

NCTNCT06709040Other idNN8640-4787Other idU1111-1294-5941

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Overview

Status: Enrolling by invitation
Phase: Phase not stated
Enrollment: 500 participants (estimated)
Sponsor: Novo Nordisk A/S · Industry
Design: Not stated
Countries: 1 country
United Kingdom
Start: 13 Dec 2024
Primary completion: 14 Apr 2034 (estimated)
Completion: 14 Apr 2034 (estimated)
First posted: 29 Nov 2024
Last update posted: 6 Apr 2026
Conditions: Growth Hormone Deficiency · Neoplasms · Diabetes Mellitus Type 2

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202420262028203020322034

Ph –
A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters
NCT06709040
13 Dec 2024 to est. 14 Apr 2034

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

SomapacitanDrug

Arms1

Other
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of adverse drug reactions
Time frame · From baseline (week 0) to end of study (up to 10 years)
Registry description
Measured as count of events.

Secondary outcomes(11)

Number of medication errors (incorrect dose administration)
Time frame · From baseline (week 0) to end of study (up to 10 years)
Registry description
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)
Registry description
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)
Registry description
Measured as number of participants (yes/no).
Height velocity
Time frame · From baseline (week 0) to end of study (up to 10 years)
Registry description
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)
Registry description
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)
Registry description
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)
Registry description
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)
Registry description
Measured as years.
Change in bone age (measured as months)
Time frame · From baseline (week 0) to end of study (up to 10 years)
Registry description
Measured as months.
Participants reaching near adult height
Time frame · at 10 year
Registry description
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.
Change in height SDS in participants reaching near adult height
Time frame · From baseline (week 0) to end of study (up to 10 years)
Registry description
Near adult height can be 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 score ranging from -10 to +10. Only for those who are expected to reach near adult height during the study.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: up to 18 Years
Healthy volunteers: Not stated

Inclusion and exclusion criteria, as posted

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.

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