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Clinical Trial Details

Trial ID: L3792
Source ID: NCT06709040
Associated Drug: Somapacitan
Title: A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters
Acronym:
Status: ENROLLING_BY_INVITATION
Study Results: NO
Results:
Conditions: Growth Hormone Deficiency|Neoplasms|Diabetes Mellitus Type 2
Interventions: DRUG: Somapacitan
Outcome Measures: Primary: Number of adverse drug reactions, Measured as count of events., From baseline (week 0) to end of study (up to 10 years) | Secondary: Number of medication errors (incorrect dose administration), Measured as count of errors., From baseline (week 0) to end of study (up to 10 years)|Number of participants with incident neoplasm, Measured as number of participants (yes/no)., From baseline (week 0) to end of study (up to 10 years)|Number of participants with incident diabetes mellitus type 2, Measured as number of participants (yes/no)., From baseline (week 0) to end of study (up to 10 years)|Height velocity, measured as centimeter per year (cm/year)., From baseline (week 0) to end of study (up to 10 years)|Change in height velocity standard deviation score (HVSDS), Measured as score ranging from -10 to +10., From baseline (week 0) to end of study (up to 10 years)|Change in height standard deviation score (HSDS), Measured as score ranging from -10 to +10., 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), Measured as score ranging from -10 to +10., From baseline (week 0) to end of study (up to 10 years)|Change in bone age (measured as years), Measured as years., From baseline (week 0) to end of study (up to 10 years)|Change in bone age (measured as months), Measured as months., From baseline (week 0) to end of study (up to 10 years)|Participants reaching near adult height, 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., at 10 year|Change in height SDS in participants reaching near adult height, 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., From baseline (week 0) to end of study (up to 10 years)
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: CHILD, ADULT
Phases:
Enrollment: 500
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2024-12-13
Completion Date: 2034-04-14
Results First Posted:
Last Update Posted: 2025-02-05
Locations: University of Glasgow, Glasgow, Scotland, United Kingdom
URL: https://clinicaltrials.gov/show/NCT06709040