A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters
- Conditions
- Interventions
- Registration Number
- NCT06709040
- Lead Sponsor
- Novo Nordisk A/S
- Brief 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 Con...
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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.
- Participants with active malignancy or in treatment for active pre-existing malignancy.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with Growth Hormone Deficieny Somapacitan 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 Outcome Measures
Name Time Method Number of adverse drug reactions From baseline (week 0) to end of study (up to 10 years) Measured as count of events.
- Secondary Outcome Measures
Name Time Method Number of medication errors (incorrect dose administration) From baseline (week 0) to end of study (up to 10 years) Measured as count of errors.
Number of participants with incident neoplasm 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 From baseline (week 0) to end of study (up to 10 years) Measured as number of participants (yes/no).
Height velocity 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) 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) 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) 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) From baseline (week 0) to end of study (up to 10 years) Measured as years.
Change in bone age (measured as months) From baseline (week 0) to end of study (up to 10 years) Measured as months.
Participants reaching near adult height 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.
Change in height SDS in participants reaching near adult height From baseline (week 0) to end of study (up to 10 years) 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.