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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1294-5941 | Other Identifier | World Health Organization (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somapacitan | Drug | Participants will be treated with commercially available somapacitan according to routine clinical practice at the discretion of the treating physician. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse drug reactions | Measured as count of events. | From baseline (week 0) to end of study (up to 10 years) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Paediatric participants with growth hormone deficiency
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 2834) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Glasgow | Glasgow | Scotland | United Kingdom |
According to the Novo Nordisk disclosure commitment on novonordisktrials.com
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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) |
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| D009369 | Neoplasms |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000718308 | somapacitan |
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