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

A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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