Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®
Study Details
Study Description
Brief Summary
Participants are invited to take part in this study because they have AGHD (only severe case). The purpose of this study is to assess long term safety and effectiveness of Sogroya® in patients with AGHD (only severe case) under normal clinical practice condition in Japan. Participants will get Sogroya® as prescribed by the study doctor. Participants will be in the study for about 2 to 5 years depending on when they take part in the study. Participants will be asked to fill in the quality of life questionnaires.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Participants with AGHD (only severe case) Participants will be treated with commercially available Sogroya® according to routine clinical practice at the discretion of the treating physician. The decision to treat a patient with Sogroya® has been made at the treating physician's discretion and independently from the decision to include the patient in this study. |
Drug: Somapacitan
Sogroya® therapy in participants with AGHD (only severe case) under normal clinical practice conditions
Other Names:
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Outcome Measures
Primary Outcome Measures
- Number of adverse events [From baseline (week 0) to end of study (up to 260 weeks)]
Measured as number
- Number of serious adverse events [From baseline (week 0) to end of study (up to 260 weeks)]
Measured as number
- Number of serious adverse reactions [From baseline (week 0) to end of study (up to 260 weeks)]
Measured as number
- Number of adverse reactions [From baseline (week 0) to end of study (up to 260 weeks)]
Measured as number
Secondary Outcome Measures
- Change in body fat mass [From baseline (week 0) to end of study (up to 260 weeks)]
Measured as kilogram (kg)
- Change in body fat percentage [From baseline (week 0) to end of study (up to 260 weeks)]
Measured as percent (%)
- Change in lean body mass [From baseline (week 0) to end of study (up to 260 weeks)]
Measured as kg
- Change in cross-sectional total adipose tissue compartments (TAT) [From baseline (week 0) to end of study (up to 260 weeks)]
Measured as square centimeter (cm^2)
- Change in subcutaneous adipose tissue compartments (SAT) [From baseline (week 0) to end of study (up to 260 weeks)]
Measured as cm^2
- Change in visceral adipose tissue compartments (VAT) [From baseline (week 0) to end of study (up to 260 weeks)]
Measured as cm^2
- Change in Total cholesterol (T-Cho) [From baseline (week 0) to end of study (up to 260 weeks)]
Measured as milligrams per deciliter (mg/dL)
- Change in Low Density Lipoprotein-Cholesterol (LDL-Cho) [From baseline (week 0) to end of study (up to 260 weeks)]
Measured as mg/dL
- Change in High Density Lipoprotein-Cholesterol (HDL-Cho) [From baseline (week 0) to end of study (up to 260 weeks)]
Measured as mg/dL
- Change in triglyceride [From baseline (week 0) to end of study (up to 260 weeks)]
Measured as mg/dL
- Change in Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS) [From baseline (week 0) to end of study (up to 260 weeks)]
Measured as standard deviation score
- Change in Quality of Life (QOL) Adult Hypopituitarism Questionnaire (AHQ) score [From baseline (week 0) to end of study (up to 260 weeks)]
Measured as score range (0 = unfavorable to 6 = favorable)
- Change in QOL Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD) score [From baseline (week 0) to end of study (up to 260 weeks)]
Measured as score range (1 to 5; lower score indicates a better health state)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol)
-
The decision to initiate treatment with commercially available Sogroya® has been made by the patient/LAR and the treating physician before and independently from the decision to include the patient in this study.
-
Male or female, no age limitation
-
Diagnosis of AGHD (only severe case)
-
GH treatment naïve ("naïve patients") or "switched patients". "Naïve patients" are patients who are not exposed to any GH product to date or patients who were exposed to other GH product more than 180 days prior to registration. "Switched patients" are patients who is now treated by other GH product or patients who were exposed to other GH product within 180 days prior to registration.
Exclusion Criteria:
-
Previous participation in this study. Participation is defined as having given informed consent in this study
-
Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
-
Patients with hypersensitivity to the active substance or to any of the excipients
-
Patients with malignant tumor
-
Female patients who are either pregnant or likely to be pregnant
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Fukuoka | Japan | 818 8502 | |
| 2 | Novo Nordisk Investigational Site | Kumamoto-shi, Kumamoto | Japan | 860-0811 | |
| 3 | Novo Nordisk Investigational Site | Nara | Japan | 633-0064 | |
| 4 | Novo Nordisk Investigational Site | Osaka | Japan | 572-0085 | |
| 5 | Novo Nordisk Investigational Site | Tokyo | Japan | 112-0001 |
Sponsors and Collaborators
- Novo Nordisk A/S
Investigators
- Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NN8640-4638
- U1111-1247-5417