Status:
RECRUITING
A Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin
Lead Sponsor:
Ascendis Pharma Endocrinology Division A/S
Conditions:
Growth Hormone Deficiency
Eligibility:
All Genders
1-18 years
Brief 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...
Eligibility Criteria
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
Key Trial Info
Start Date :
March 20 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2033
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05775523
Start Date
March 20 2023
End Date
March 1 2033
Last Update
February 4 2026
Active Locations (27)
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1
Ascendis Investigational Site
Phoenix, Arizona, United States, 85054
2
Ascendis Investigational Site
Orange, California, United States, 92868
3
Ascendis Investigational Site
Sacramento, California, United States, 95821
4
Ascendis Investigational Site
San Francisco, California, United States, 94143