Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®

Adult Growth Hormone Deficiency Clinical Trial

Official title:

Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya® A Multi-centre, Prospective, Open Label, Single-arm, Observational, Non-interventional Post-marketing Study to Investigate the Long-term Safety and Clinical Parameters of Sogroya® Therapy in Patients With Adult Growth Hormone Deficiency (AGHD) (Only Severe Case) Under Normal Clinical Practice Conditions in Japan

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05230550
• Other study ID #: NN8640-4638
• Secondary ID: U1111-1247-5417
• Status: Enrolling by invitation
• Start date: February 3, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Gender: All
• Age group: N/A and older

Eligibility

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® has been made by the patient/LAR and the treating physician before and independently from the decision to include the patient in this study.

3. Male or female, no age limitation

4. Diagnosis of AGHD (only severe case)

5. 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:

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 hypersensitivity to the active substance or to any of the excipients

4. Patients with malignant tumor

5. Female patients who are either pregnant or likely to be pregnant

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Dwarfism, Pituitary

Intervention

Drug:
• Somapacitan
Sogroya® therapy in participants with AGHD (only severe case) under normal clinical practice conditions

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Fukuoka
Japan	Novo Nordisk Investigational Site	Kumamoto
Japan	Novo Nordisk Investigational Site	Kumamoto-shi, Kumamoto
Japan	Novo Nordisk Investigational Site	Kyoto-shi, Kyoto
Japan	Novo Nordisk Investigational Site	Nara
Japan	Novo Nordisk Investigational Site	Oosakashi
Japan	Novo Nordisk Investigational Site	Osaka
Japan	Novo Nordisk Investigational Site	Osaka
Japan	Novo Nordisk Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events	Measured as number	From baseline (week 0) to end of study (up to 260 weeks)
Primary	Number of serious adverse events	Measured as number	From baseline (week 0) to end of study (up to 260 weeks)
Primary	Number of serious adverse reactions	Measured as number	From baseline (week 0) to end of study (up to 260 weeks)
Primary	Number of adverse reactions	Measured as number	From baseline (week 0) to end of study (up to 260 weeks)
Secondary	Change in body fat mass	Measured as kilogram (kg)	From baseline (week 0) to end of study (up to 260 weeks)
Secondary	Change in body fat percentage	Measured as percent (%)	From baseline (week 0) to end of study (up to 260 weeks)
Secondary	Change in lean body mass	Measured as kg	From baseline (week 0) to end of study (up to 260 weeks)
Secondary	Change in cross-sectional total adipose tissue compartments (TAT)	Measured as square centimeter (cm^2)	From baseline (week 0) to end of study (up to 260 weeks)
Secondary	Change in subcutaneous adipose tissue compartments (SAT)	Measured as cm^2	From baseline (week 0) to end of study (up to 260 weeks)
Secondary	Change in visceral adipose tissue compartments (VAT)	Measured as cm^2	From baseline (week 0) to end of study (up to 260 weeks)
Secondary	Change in Total cholesterol (T-Cho)	Measured as milligrams per deciliter (mg/dL)	From baseline (week 0) to end of study (up to 260 weeks)
Secondary	Change in Low Density Lipoprotein-Cholesterol (LDL-Cho)	Measured as mg/dL	From baseline (week 0) to end of study (up to 260 weeks)
Secondary	Change in High Density Lipoprotein-Cholesterol (HDL-Cho)	Measured as mg/dL	From baseline (week 0) to end of study (up to 260 weeks)
Secondary	Change in triglyceride	Measured as mg/dL	From baseline (week 0) to end of study (up to 260 weeks)
Secondary	Change in Insulin-like Growth Factor I (IGF-I) standard deviation score (SDS)	Measured as standard deviation score	From baseline (week 0) to end of study (up to 260 weeks)
Secondary	Change in Quality of Life (QOL) Adult Hypopituitarism Questionnaire (AHQ) score	Measured as score range (0 = unfavorable to 6 = favorable)	From baseline (week 0) to end of study (up to 260 weeks)
Secondary	Change in QOL Treatment Related Impact Measure-Adult Growth Hormone Deficiency (TRIM-AGHD) score	Measured as score range (1 to 5; lower score indicates a better health state)	From baseline (week 0) to end of study (up to 260 weeks)