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

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.

Conditions

Growth Hormone Deficiency

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Growth Hormone Deficiency
Intervention / Treatment

-

Contacts and Locations

Centennial

Ascendis Pharma Investigational Site, Centennial, Colorado, United States, 80112

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

1 Year to 18 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ascendis Pharma Endocrinology Division A/S,

Study Record Dates

2033-03