RecruitingNCT05775523
A Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin
A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin
Sponsor
Ascendis Pharma Endocrinology Division A/S
Enrollment
500 participants
Start Date
Mar 20, 2023
Study Type
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Min Age: 1 YearMax Age: 18 Years
Inclusion Criteria4
- 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 Criteria7
- 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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Interventions
DRUGNo intervention
No intervention
Locations(27)
View Full Details on ClinicalTrials.gov
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NCT05775523
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