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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

  • Clinical Trial Information

    Trial Contact: Tilme, Linda; Beltran, Yajira

    Trial Phone: 321.843.5278 ; 321.841.7619

  • 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

  • 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.

  • 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