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