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A Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin

Recruitingn/aAges 1 Year - 18 YearsAllAscendis Pharma Endocrinology Division A/S
NCT05775523 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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
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What it tests

  • No intervention
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Where

27 sites
Ascendis Investigational Site
Phoenix, United States
Ascendis Investigational Site
Orange, United States
Ascendis Investigational Site
Sacramento, United States
Ascendis Investigational Site
San Francisco, United States
Ascendis Pharma Investigational Site
Centennial, United States
Ascendis Investigational Site
Washington D.C., United States
Ascendis Investigational Site
Orlando, United States
Ascendis Investigational Site
Orlando, United States

…and 19 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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