Active — Not RecruitingNot Applicable

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

Japan200 participantsStarted 2022-02-03

Plain-language 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.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of adverse events

Timeframe: From baseline (week 0) to end of study (up to 260 weeks)

Number of serious adverse events

Timeframe: From baseline (week 0) to end of study (up to 260 weeks)

Number of serious adverse reactions

Timeframe: From baseline (week 0) to end of study (up to 260 weeks)

Number of adverse reactions

Timeframe: From baseline (week 0) to end of study (up to 260 weeks)

Trial details

NCT IDNCT05230550

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Adult Growth Hormone Deficiency trials

Plain-language summary

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of adverse events

Timeframe: From baseline (week 0) to end of study (up to 260 weeks)

Number of serious adverse events

Timeframe: From baseline (week 0) to end of study (up to 260 weeks)

Number of serious adverse reactions

Timeframe: From baseline (week 0) to end of study (up to 260 weeks)

Number of adverse reactions

Timeframe: From baseline (week 0) to end of study (up to 260 weeks)