A US Non-interventional, Effectiveness and Safety Study of Patients Treated With SKYTROFA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No intervention.
- Who it may be relevant to
- Registry conditions: Growth Hormone Deficiency. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A US Multi-center, Prospective, Non-interventional, Long Term, Effectiveness and Safety Study of Patients Treated With SKYTROFA (Lonapegsomatropin)
Overview
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
Detailed description
Patients will be treated according to routine clinical practice, and no additional visits, examinations or tests will be required beyond those performed as part of routine clinical practice except for COAs.
Interventions
- Other No intervention
No intervention
Primary outcome measures
- Assess the safety of patients treated with SKYTROFA (Lonapegsomatropin) [Time frame: 5 years]
- Assess the effectiveness of patients treated with SKYTROFA (Lonapegsomatropin) [Time frame: 5 years]
Secondary outcome measures (2)
- Assess clinical outcome assessments (COAs) [Time frame: 5 years]
- Assess clinical outcome assessments (COAs) [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Patients participating in any interventional clinical study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 27 centers
- Ascendis Investigational Site — Phoenix
- Ascendis Investigational Site — Orange
- Ascendis Investigational Site — Sacramento
- Ascendis Investigational Site — San Francisco
- Ascendis Pharma Investigational Site — Centennial
- Ascendis Investigational Site — Washington D.C.
- Ascendis Investigational Site — Orlando
- Ascendis Investigational Site — Orlando
- … and 19 more centers
Identifiers
NCT: NCT05820672 · ASND0037