SkyPASS: A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated with Lonapegsomatropin
SkyPASS: A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated with Lonapegsomatropin
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Clinical Trial Information
Trial Contact: Tilme, Linda; Beltran, Yajira
Trial Phone: 321.843.5278 ; 321.841.7619
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IRB No: 23.094.05
Protocol Abbrev: ASND0033
Principal Investigator: Joshua H Yang, MD
Phase: Drug: Phase III
Age Group: Pediatric
ClinicalTrials.gov ID: NCT05775523
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Objective
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.
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Key Eligibility
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
