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

a study on Growth Hormone Deficiency

Summary

Eligibility
for people ages 1-18 (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

Summary

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.

Official Title

A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin

Keywords

Growth Hormone Deficiency, Human Growth Hormone, hGH, rhGH, GHD, Long Acting Growth Hormone, Lonapegsomatropin, Prodrug, Growth Failure, Growth Hormone Replacement Therapy, Sustained Release Growth Hormone, TransCon hGH, Skytrofa, SkyPASS

Eligibility

You can join if…

Open to people ages 1-18

  • 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

You CAN'T join if...

  • 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

Locations

  • Ascendis Investigational Site accepting new patients
    San Francisco California 94143 United States
  • Ascendis Investigational Site accepting new patients
    Sacramento California 95821 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ascendis Pharma Endocrinology Division A/S
ID
NCT05775523
Study Type
Observational
Participants
Expecting 500 study participants
Last Updated