Health Condition 1: E230- Hypopituitarism
Conditions
Interventions
Intervention1: NIL: This study is a post-marketing surveillance study and is observational and non-interventional in nature.
Control Intervention1: Not applicable: This study is a post-marketing surve
Sponsors
Novo Nordisk India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). 2. The decision to initiate treatment with commercially available somapacitan has been made by the patient and the treating physician before and independently from the decision to include the patient in this study. 3. Confirmed diagnosis of GHD as per local practice. 4. Male or female below 18 years of age assigned to somapacitan treatment at the time of signing informed consent
Exclusion criteria
Exclusion criteria: 1. Previous participation in this study. Participation is defined as having given informed consent in this study. 2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. 3. Patients with active malignancy or in treatment for active pre-existing malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate long-term safety of somapacitan treatment in paediatric patients with GHD in the setting of routine clinical practice with special focus on neoplasms, medication errors and Type 2 Diabetes Mellitus.Timepoint: From baseline (week 0) to End of Study (up to 3 years) | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate safety and clinical parameters of somapacitan treatment in paediatric patients with GHD in the setting of routine clinical practice.Timepoint: From baseline (week 0) to End of Study (up to 3 years) | — |
Countries
India
Contacts
Public ContactDr Maya Sharma
Novo Nordisk India Private Limited
Outcome results
None listed