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NCT05775523 Clinical Trial

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

Growth Hormone Deficiency Clinical Trial

— SkyPASS  

Official title:
A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05775523
Other study ID # ASND0033
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 20, 2023
Est. completion date March 2033

Study information
Verified date January 2024
Source Ascendis Pharma A/S
Contact Mandeep Singh
Phone +1 650-505-4946
Email msh@ascendispharma.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date March 2033
Est. primary completion date March 2033
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• No intervention
No intervention

Locations
Country Name City State
United States Ascendis Pharma Investigational Site Centennial Colorado

Sponsors (1)
Lead Sponsor Collaborator
Ascendis Pharma Endocrinology Division A/S

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of neoplasms (benign, malignant and unspecified) 5 years
Primary Occurrence of type 2 diabetes mellitus 5 years
Secondary Occurrence of renal, hepatic, immunologic and neurologic adverse events 5 years
Secondary Occurrence of medication errors in patients treated with lonapegsomatropin Frequency and type of medication errors as reported by treating physician 5 years
Secondary Insulin-like Growth Factor-1 (IGF-1) response to lonapegsomatropin therapy IGF-1 level (ng/mL) 5 years
Secondary Insulin-like Growth Factor-1 (IGF-1) response to lonapegsomatropin therapy IGF-1 Standard Deviation Score (SDS) 5 years
Secondary Compare the occurrence of neoplasms (benign, malignant and unspecified) in patients treated with lonapegsomatropin with historical data from literature 5 years
Secondary Compare the occurrence of type 2 diabetes mellitus in patients treated with lonapegsomatropin with historical data from literature 5 years
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