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SkyPASS Registry

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 contact
[email protected] or visit ClinicalTrials.gov (NCT05775523).

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