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Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya® | Clinical Trials | Clareo Health

ENROLLING_BY_INVITATION

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

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

NCT05230550•Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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

Locations (47)

Ikeda Hospital, Diabetes Medicine

Amagasaki-shi, Hyogo, Japan

University of Yamanashi Hospital

Chuo-shi, Yamanashi-ken, Japan

Fukuoka University Chikushi Hospital_Endocrinology and Diabetes Mellitus

Fukuoka, Japan

Kurume University Hospital

Fukuoka, Japan

Fukuoka University Hospital

Fukuoka-shi, Fukuoka-ken, Japan

Kyushu University Hospital

Fukuoka-shi, Fukuoka, Japan

Gifu University Hospital

Gifu, Japan

Tsugaru General Hospital

Goshogawara-shi, Aomori-ken, Japan

Gunma University Hospital, Dept. of Endocrinology and Diabetes

Gunma, Japan

Hamamatsu University Hospital

Hamamatsu-shi, Shizuoka, Japan

Key Dates

Start Date

February 3, 2022

Primary Completion Date

December 31, 2026

Completion Date

December 31, 2026

Last Updated

April 9, 2025

Enrollment

200

ESTIMATED participants

Conditions

Adult Growth Hormone Deficiency

Interventions

Somapacitan

DRUG

A Study of GS3-007a for Oral Suspension in the Diagnosis of Adult Growth Hormone Deficiency (AGHD)

NCT07259564

Adult Growth Hormone Deficiency (AGHD)

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COMPLETEDPHASE1

First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

NCT01514500

Growth Hormone DisorderAdult Growth Hormone Deficiency+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study of GS3-007a for Oral Suspension in the Diagnosis of Adult Growth Hormone Deficiency (AGHD)

First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

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Observational Prospective Study on Patients Treated With Norditropin®