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

Launched by ASCENDIS PHARMA ENDOCRINOLOGY DIVISION A/S · Mar 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety of a treatment called lonapegsomatropin for children and young adults with Growth Hormone Deficiency (GHD). The goal is to understand how this treatment affects patients in real-life situations, after it has been approved for use. The study is currently recruiting participants who are receiving lonapegsomatropin and are being treated in Europe or the USA.

To be eligible for the study, participants must be pediatric patients diagnosed with GHD who are currently on lonapegsomatropin. They will need to have parental or guardian consent, and they must be willing to attend follow-up appointments. However, some individuals may not qualify if they are involved in other clinical trials, have certain medical conditions, or are receiving other hormone treatments. Participants will be closely monitored throughout the study to ensure their safety and gather important information about the treatment's effects.

Gender

ALL

Eligibility criteria

• 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