Clinical trial · Observational
A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters
A Non-interventional, Observational, Registry-based Study to Investigate Long-term Safety and Clinical Parameters of Somapacitan Treatment in Paediatric Patients With Growth Hormone Deficiency During Routine Clinical Practice
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diabetes Mellitus Type 2 | — | UNRESOLVED | — |
| Growth Hormone Deficiency | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Somapacitan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants with Growth Hormone Deficieny
- description
- 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.
- interventionNames
- Drug: Somapacitan
Primary outcomes (1)
- measure
- Number of adverse drug reactions
- timeFrame
- From baseline (week 0) to end of study (up to 10 years)
- description
- Measured as count of events.
Secondary outcomes (11)
- measure
- Number of medication errors (incorrect dose administration)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available