Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around

Description

Summary

In this study, the general long-term safety and effectiveness of Sogroya (somapacitan) in adults with growth hormone deficiency (AGHD) being treated per normal clinical practice is looked into. In the study, information on side effects and how well Sogroya (somapacitan) works during long term treatment in people with Adult Growth Hormone Deficiency (AGHD) will be collected and analysed. Participants will be treated with Sogroya (somapacitan) as prescribed by the study doctor, in accordance with normal clinical practice. The study will last for 5-10 years, depending on when the participant join the study. The participant will be asked to complete two short questionnaires during every visit to the clinic. The questionnaires will collect information on the participant's well-being, work ability and ability to perform daily activities.

Official Title

A Multi-national, Multi-centre, Prospective, Single-arm, Observational, Non-interventional Post-authorisation Safety Study to Investigate Long-term Safety of Sogroya® (Somapacitan) in Adults With Growth Hormone Deficiency (AGHD) Under Routine Clinical Practice

Keywords

Adult Growth Hormone Deficiency, Pituitary Dwarfism, Endocrine System Diseases, Somapacitan

Eligibility

You can join if…

Open to people ages 18 years and up

  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 (somapacitan) has been made by the participant and the treating physician before and independently from the decision to include the participant in this study.
  3. Male or female, age above or equal to 18 years assigned to Sogroya (somapacitan) treatment at the time of signing informed consent.
  4. Diagnosis of adult growth hormone deficiency (AGHD) as per local practice.

You CAN'T join if...

  1. Previous participation in this study. Participation is defined as signed informed consent.
  2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
  3. Participant with hypersensitivity to the active substance or to any of the excipients.
  4. Participant with active malignancy or in treatment for active pre-existing malignancy.
  5. Participant with acute critical illness, suffering from complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions per investigator judgement.

Locations

  • UCLA Health
    Los Angeles California 90095 United States
  • Advanced Rx Clinical Research
    Westminster California 92683 United States
  • Keck Medical Center of USC - Outpatient Clinic
    Los Angeles California 90033 United States
  • Stanford Univ School of Med
    Palo Alto California 94304 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Novo Nordisk A/S
ID
NCT05718570
Study Type
Observational
Participants
Expecting 400 study participants
Last Updated