About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients participating in any interventional clinical study
Trial population
Patients being treated with SKYTROFA who are associated to selected endocrinology or pediatric clinics across USA.
Trial design
Cohort
Prospective
Treatments tested in this trial
No intervention
Other interventionNo intervention
Treatment groups
Trial outcomes
Primary outcomes
Assess the safety of patients treated with SKYTROFA (Lonapegsomatropin)
Incidence of Adverse Events and Serious Adverse Events
Assess the effectiveness of patients treated with SKYTROFA (Lonapegsomatropin)
Near adult height (cm)
Secondary outcomes
Assess clinical outcome assessments (COAs)
Change in Quality of Life in Short Stature Youth (QoLISSY) scores from baseline through End of Study (QOLISSY scores range on a scale of 0 to 100 with higher scores representing better quality of life. (For both child and parent version))
Assess clinical outcome assessments (COAs)
Change in Treatment Satisfaction Questionnaire for Medicine (TSQM-9) scores from baseline through End of Study (The TSQM-9 domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain)
Sponsors and contacts
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