A US Non-interventional, Effectiveness and Safety Study of Patients Treated With SKYTROFA
SkybriGHt
A US Multi-center, Prospective, Non-interventional, Long Term, Effectiveness and Safety Study of Patients Treated With SKYTROFA (Lonapegsomatropin)
1 other identifier
observational
900
1 country
27
Brief Summary
The goal of this study is to genrate evidence on long-term effectiveness and safety of SKYTROFA (lonapegsomatropin) in patients with growth hormone deficiency under routine clinical care
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2023
CompletedStudy Start
First participant enrolled
March 20, 2023
CompletedFirst Posted
Study publicly available on registry
April 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
April 21, 2026
April 1, 2026
10 years
March 7, 2023
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Assess the safety of patients treated with SKYTROFA (Lonapegsomatropin)
Incidence of Adverse Events and Serious Adverse Events
5 years
Assess the effectiveness of patients treated with SKYTROFA (Lonapegsomatropin)
Near adult height (cm)
5 years
Secondary Outcomes (2)
Assess clinical outcome assessments (COAs)
5 years
Assess clinical outcome assessments (COAs)
5 years
Study Arms (1)
Patients on SKYTROFA Treatment
Patients on SKYTROFA Treatment managed in USA with appropriate written Informed Consent
Interventions
Eligibility Criteria
Patients being treated with SKYTROFA who are associated to selected endocrinology or pediatric clinics across USA.
You may qualify if:
- Patients who are on treatment with SKYTROFA (lonapegsomatropin)
- Patients being clinically managed in USA
- Patients with an appropriate written informed consent/assent as applicable for the age of the patient
You may not qualify if:
- Patients participating in any interventional clinical study
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
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2023
First Posted
April 20, 2023
Study Start
March 20, 2023
Primary Completion (Estimated)
March 1, 2033
Study Completion (Estimated)
March 1, 2033
Last Updated
April 21, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share