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

ASND0033

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.

2023-03-20

2033-03-01

2033-03-01

Recruiting

500

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

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 500, 'type': 'ESTIMATED'}}

2024-01-10