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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorAscendis Pharma Endocrinology Division A/S

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • No intervention

Treatment groups

500 Participants
are divided into 1 treatment group

Locations

27
Arizona
Ascendis Investigational Site85054, Phoenix United States
California
Ascendis Investigational Site92868, Orange United States
Ascendis Investigational Site95821, Sacramento United States
Ascendis Investigational Site94143, San Francisco United States

Sponsors and collaborators

Ascendis Pharma Endocrinology Division A/S

Lead sponsor