Clinical trial NCT05820672: A US Non-interventional, Effectiveness and Safety Study of Patients Treated With SKYTROFA
Official title: A US Multi-center, Prospective, Non-interventional, Long Term, Effectiveness and Safety Study of Patients Treated With SKYTROFA (Lonapegsomatropin)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Growth Hormone Deficiency
Keywords: Human Growth Hormone
SKYTROFA
Lead sponsor: Ascendis Pharma A/S
Sponsor class: INDUSTRY
First posted: 2023-04-20
Enrollment: 900
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being treated with SKYTROFA who are associated to selected endocrinology or pediatric clinics across USA.

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

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.

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

Primary outcomes:
measure: Assess the safety of patients treated with SKYTROFA (Lonapegsomatropin)
timeFrame: 5 years
measure: Assess the effectiveness of patients treated with SKYTROFA (Lonapegsomatropin)
timeFrame: 5 years
Secondary outcomes:
measure: Assess clinical outcome assessments (COAs)
timeFrame: 5 years
measure: Assess clinical outcome assessments (COAs)
timeFrame: 5 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Ascendis Investigational Site
state: Arizona
city: Sacramento
country: United States
facility: Ascendis Investigational Site
state: California
city: San Francisco
country: United States
facility: Ascendis Investigational Site
state: California
city: Centennial
country: United States
facility: Ascendis Pharma Investigational Site
state: Colorado
city: Washington
country: United States
facility: Ascendis Investigational Site
state: District of Columbia
city: Orlando
country: United States
facility: Ascendis Investigational Site
state: Florida
city: Orlando
country: United States
facility: Ascendis Investigational Site
state: Florida
city: Tampa
country: United States
facility: Ascendis Investigational Site
state: Florida
city: Sandy Springs
country: United States
facility: Ascendis Investigational Site
state: Georgia
city: Boise
country: United States
facility: Ascendis Investigational Site
state: Idaho
city: Indianapolis
country: United States
facility: Ascendis Investigational Site
state: Indiana
city: Iowa City
country: United States
facility: Ascendis Investigational Site
state: Iowa
city: Louisville
country: United States
facility: Ascendis Investigational Site
state: Kentucky
city: Minneapolis
country: United States
facility: Ascendis Investigational Site
state: Minnesota
city: Las Vegas
country: United States
facility: Ascendis Investigational Site
state: Nevada
city: Lebanon
country: United States
facility: Ascendis Investigational Site
state: New Hampshire
city: Morristown
country: United States
facility: Ascendis Investigational Site
state: New Jersey
city: New Brunswick
country: United States
facility: Ascendis Investigational Site
state: New Jersey
city: New Hyde Park
country: United States
facility: Ascendis Investigational Site
state: New York
city: Portland
country: United States
facility: Ascendis Investigational Site
state: Oregon
city: Columbia
country: United States
facility: Ascendis Investigational Site
state: South Carolina
city: El Paso
country: United States
facility: Ascendis Investigational Site
state: Texas
city: Norfolk
country: United States
facility: Ascendis Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Ascendis Investigational Site
state: Washington
Study officials:
References: