RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-03-20
Study Completion:2033-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05775523

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Paediatric patients with GHD who are on treatment with lonapegsomatropin
  2. * Patients being clinically managed in Europe or the USA
  3. * Appropriate written informed consent/assent as applicable for the age of the patient
  4. * Patients willing to comply with follow-up requirements of the study
  1. * Patients participating in any interventional clinical trial for short stature
  2. * Patients being treated with a GH or IGF-1 therapy, other than lonapegsomatropin, at enrollment
  3. * Patients for whom treatment with lonapegsomatropin is contraindicated
  4. * Patients with closed epiphyses
  5. * Patients with active malignant tumours
  6. * Patients under antitumour therapy within the past 12 months prior to instituting GH therapy
  7. * Hypersensitivity to somatropin or any of the excipients in lonapegsomatropin

Contacts and Locations

Study Contact

Mandeep Singh
CONTACT
+1 650-505-4946
msh@ascendispharma.com

Study Locations (Sites)

Ascendis Pharma Investigational Site
Centennial, Colorado, 80112
United States

Collaborators and Investigators

Sponsor: Ascendis Pharma Endocrinology Division A/S

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-20
Study Completion Date2033-03

Study Record Updates

Study Start Date2023-03-20
Study Completion Date2033-03

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Growth Hormone Deficiency