Adult Growth Hormone Deficiency
Conditions
Brief summary
In this study, the general long-term safety and effectiveness of Sogroya (somapacitan) in adults with growth hormone deficiency (AGHD) being treated per normal clinical practice is looked into. In the study, information on side effects and how well Sogroya (somapacitan) works during long term treatment in people with Adult Growth Hormone Deficiency (AGHD) will be collected and analysed. Participants will be treated with Sogroya (somapacitan) as prescribed by the study doctor, in accordance with normal clinical practice. The study will last for 5-10 years, depending on when the participant join the study. The participant will be asked to complete two short questionnaires during every visit to the clinic. The questionnaires will collect information on the participant's well-being, work ability and ability to perform daily activities.
Interventions
DRUGSomapacitan
Sogroya therapy in participants with AGHD.
Sponsors
Novo Nordisk A/S
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 Sogroya (somapacitan) has been made by the participant and the treating physician before and independently from the decision to include the participant in this study. 3. Male or female, age above or equal to 18 years assigned to Sogroya (somapacitan) treatment at the time of signing informed consent. 4. Diagnosis of adult growth hormone deficiency (AGHD) as per local practice.
Exclusion criteria
1. Previous participation in this study. Participation is defined as signed informed consent. 2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. 3. Participant with hypersensitivity to the active substance or to any of the excipients. 4. Participant with active malignancy or in treatment for active pre-existing malignancy. 5. Participant with acute critical illness, suffering from complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions per investigator judgement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse drug reaction (ADRs) | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as count of events. |
| Incident Neoplasm | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as number of participants (yes/no). |
| Incident Diabetes Mellitus type 2 | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as number of participants (yes/no). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events (AEs) | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as count of events. |
| Number of Serious Adverse Events (SAEs) | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as count of events. |
| Number of Medication Errors (incorrect dose administration rate) | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as count of errors. |
| Change in Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS) | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as score ranging from -10 to +10. |
| Patient achieving Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS target) (0-+2) | Approximately (closest routine clinical) 12 months after enrolment in study | Measured as number of participants (yes/no). |
| Change in Weight | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as kilogram (kg). |
| Change in Body Mass Index (BMI) | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as kilogram per square meter (kg\^m2). |
| Change in waist circumference | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as centimeter (cm). |
| Change in waist-hip ratio | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as ratio. |
| Change in lipid profile (cholesterol, High Density Lipoprotein [HDL], Low Density Lipoprotein [LDL], triglycerides) | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as milligrams per deciliter (mg/dL). |
| Change in glycated hemoglobin (HbA1C) | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as percentage (%). |
| Change in bone density | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as grams per square centimeter (g/cm\^2). |
| Change in bone mineral content | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as grams (g). |
| Change in total body fat-mass | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as kg. |
| Change in truncal fat-mass | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as kg. |
| Change in lean body mass | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as kg. |
| Change in body fat percentage | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as %. |
| Change in visceral adipose tissue (VAT) | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as cm\^2. |
| Change in Liver function (Aspartate aminotransferase [AST], Alanine transaminase [ALT], Gamma-Glytamyltransferase [GGT], bilirubin) | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as Units per liter (U/L). |
| Change in Patient reported outcome (PRO) score, Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD) | From baseline (week 0) to end of study (between 1 week and a maximum of 10 years) | Measured as score ranging from -100 to +100. Lower score indicates a better health state. |
| Patient reaching satisfactory clinical response | Approximately (closest routine clinical) 12 months after enrolment in study | Measured as number of participants (yes/no). |
Countries
France, Germany, Japan, Saudi Arabia, Slovenia, United States
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed