SkyPASS

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

Inclusion Criteria

  • Pediatric patients with GHD who are on treatment with lonapegsomatropin-tcgd
  • 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-tcgd, at enrollment
  • Patients for whom treatment with lonapegsomatropin-tcgd is contraindicated
  • Patients with closed epiphyses
  • Patients with active malignant tumors
  • Patients under antitumor therapy within the past 12 months prior to instituting GH therapy
  • Hypersensitivity to somatropin or any of the excipients in lonapegsomatropin-tcgd
Abbreviations: GH, growth hormone; GHD, growth hormone deficiency; IGF-1, insulin-like growth factor 1.

For additional study information and for inclusion/exclusion criteria: Healthcare providers may visit ClinicalTrials.gov (NCT05775523).

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