A Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin

Recruiting now

Conditions studied: Growth Hormone Deficiency

In brief

The goal of this study is to further characterise the potential long-term safety risks of lonapegsomatropin in patients treated with lonapegsomatropin under real-world conditions in the post-marketing setting.

Key facts

Study ID

NCT05775523

Run by

Ascendis Pharma Endocrinology Division A/S

People needed

500

Starts

2023-03-20

Expected to finish

2033-03-01

Last updated by the study team

2026-02-04

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Paediatric patients with GHD who are on treatment with lonapegsomatropin
• Patients being clinically managed in Europe or the USA
• Appropriate written informed consent/assent as applicable for the age of the patient
• Patients willing to comply with follow-up requirements of the study

You may not qualify if…

• Patients participating in any interventional clinical trial for short stature
• Patients being treated with a GH or IGF-1 therapy, other than lonapegsomatropin, at enrollment
• Patients for whom treatment with lonapegsomatropin is contraindicated
• Patients with closed epiphyses
• Patients with active malignant tumours
• Patients under antitumour therapy within the past 12 months prior to instituting GH therapy
• Hypersensitivity to somatropin or any of the excipients in lonapegsomatropin

Where it is running

• Ascendis Investigational Site — Phoenix, Arizona, United States (enrolling)
• Ascendis Investigational Site — Orange, California, United States (enrolling)
• Ascendis Investigational Site — Sacramento, California, United States (enrolling)
• Ascendis Investigational Site — San Francisco, California, United States (enrolling)
• Ascendis Pharma Investigational Site — Centennial, Colorado, United States (enrolling)
• Ascendis Investigational Site — Washington D.C., District of Columbia, United States (enrolling)
• Ascendis Investigational Site — Orlando, Florida, United States (enrolling)
• Ascendis Investigational Site — Orlando, Florida, United States (enrolling)
• Ascendis Investigational Site — Tampa, Florida, United States (enrolling)
• Ascendis Investigational Site — Sandy Springs, Georgia, United States (enrolling)
• Ascendis Investigational Site — Boise, Idaho, United States (enrolling)
• Ascendis Investigational Site — Indianapolis, Indiana, United States (enrolling)
• Ascendis Investigational Site — Iowa City, Iowa, United States (enrolling)
• Ascendis Investigational Site — Louisville, Kentucky, United States (enrolling)
• Ascendis Investigational Site — Minneapolis, Minnesota, United States (enrolling)
• Ascendis Investigational Site — Las Vegas, Nevada, United States (enrolling)
• Ascendis Investigational Site — Lebanon, New Hampshire, United States (enrolling)
• Ascendis Investigational Site — Manchester, New Hampshire, United States (enrolling)
• Ascendis Investigational Site — Morristown, New Jersey, United States (enrolling)
• Ascendis Investigational Site — New Hyde Park, New York, United States (enrolling)
• Ascendis Investigational Site — Cincinnati, Ohio, United States (enrolling)
• Ascendis Investigational Site — Portland, Oregon, United States (enrolling)
• Ascendis Investigational Site — Columbia, South Carolina, United States (enrolling)
• Ascendis Investigational Site — Dallas, Texas, United States (enrolling)
• Ascendis Investigational Site — El Paso, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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