Status:
ENROLLING_BY_INVITATION
Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Adult Growth Hormone Deficiency
Eligibility:
All Genders
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 AG...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 3 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05230550
Start Date
February 3 2022
End Date
December 31 2026
Last Update
April 9 2025
Active Locations (47)
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1
Ikeda Hospital, Diabetes Medicine
Amagasaki-shi, Hyogo, Japan, 661-0002
2
University of Yamanashi Hospital
Chuo-shi, Yamanashi-ken, Japan, 409-3821
3
Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus
Fukuoka, Japan, 818 8502
4
Kurume University Hospital
Fukuoka, Japan, 830-0011