A Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin (SkyPASS)

Ascendis Pharma

Status

Enrolling

Conditions

Growth Hormone Deficiency

Treatments

Drug: No intervention

Study type

Observational

Funder types

Industry

Identifiers

NCT05775523

ASND0033

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

1 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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