A Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin
SkyPASS
A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin
1 other identifier
observational
500
1 country
27
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 setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2023
Longer than P75 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2023
CompletedFirst Posted
Study publicly available on registry
March 20, 2023
CompletedStudy Start
First participant enrolled
March 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2033
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2033
February 4, 2026
February 1, 2026
10 years
March 8, 2023
February 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Occurrence of neoplasms (benign, malignant and unspecified)
5 years
Occurrence of type 2 diabetes mellitus
5 years
Secondary Outcomes (6)
Occurrence of renal, hepatic, immunologic and neurologic adverse events
5 years
Occurrence of medication errors in patients treated with lonapegsomatropin
5 years
Insulin-like Growth Factor-1 (IGF-1) response to lonapegsomatropin therapy
5 years
Insulin-like Growth Factor-1 (IGF-1) response to lonapegsomatropin therapy
5 years
Compare the occurrence of neoplasms (benign, malignant and unspecified) in patients treated with lonapegsomatropin with historical data from literature
5 years
- +1 more secondary outcomes
Study Arms (1)
Patients on SKYTROFA (Lonapegsomatropin)Treatment
SKYTROFA (Lonapegsomatropin) administered once-weekly by subcutaneous injection
Interventions
Eligibility Criteria
Patients from centres in Europe and the USA will be eligible for enrollment into the study. Patients may be enrolled in the study if they are on treatment with lonapegsomatropin. The decision to treat the patient with lonapegsomatropin will be made prior to and independently of the decision to invite the patient to enroll into the study. Both patients naïve to GH treatment and patients previously treated with GH therapy will be eligible for enrollment.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Ascendis Investigational Site
Phoenix, Arizona, 85054, United States
Ascendis Investigational Site
Orange, California, 92868, United States
Ascendis Investigational Site
Sacramento, California, 95821, United States
Ascendis Investigational Site
San Francisco, California, 94143, United States
Ascendis Pharma Investigational Site
Centennial, Colorado, 80112, United States
Ascendis Investigational Site
Washington D.C., District of Columbia, 20010, United States
Ascendis Investigational Site
Orlando, Florida, 32806, United States
Ascendis Investigational Site
Orlando, Florida, 32827, United States
Ascendis Investigational Site
Tampa, Florida, 33612, United States
Ascendis Investigational Site
Sandy Springs, Georgia, 30350, United States
Ascendis Investigational Site
Boise, Idaho, 83712, United States
Ascendis Investigational Site
Indianapolis, Indiana, 46202, United States
Ascendis Investigational Site
Iowa City, Iowa, 52242, United States
Ascendis Investigational Site
Louisville, Kentucky, 40202, United States
Ascendis Investigational Site
Minneapolis, Minnesota, 55455, United States
Ascendis Investigational Site
Las Vegas, Nevada, 89113, United States
Ascendis Investigational Site
Lebanon, New Hampshire, 03756, United States
Ascendis Investigational Site
Manchester, New Hampshire, 03104, United States
Ascendis Investigational Site
Morristown, New Jersey, 07960, United States
Ascendis Investigational Site
New Hyde Park, New York, 11042, United States
Ascendis Investigational Site
Cincinnati, Ohio, 45229, United States
Ascendis Investigational Site
Portland, Oregon, 97239, United States
Ascendis Investigational Site
Columbia, South Carolina, 29203, United States
Ascendis Investigational Site
Dallas, Texas, 75390, United States
Ascendis Investigational Site
El Paso, Texas, 79907, United States
Ascendis Investigational Site
Norfolk, Virginia, 23507, United States
Ascendis Investigational Site
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director, MD
Ascendis Pharma A/S
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2023
First Posted
March 20, 2023
Study Start
March 20, 2023
Primary Completion (Estimated)
March 1, 2033
Study Completion (Estimated)
March 1, 2033
Last Updated
February 4, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share