Long-term safety assessment of lonapegsomatropin in children with growth hormone deficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the long-term safety profile of lonapegsomatropin in pediatric patients diagnosed with growth hormone deficiency (GHD) who are currently receiving this treatment. By monitoring these patients in real-world clinical settings, the study seeks to identify any potential safety risks associated with lonapegsomatropin over time. The study does not involve any new interventions, focusing instead on the safety outcomes of patients already on treatment. Participants will be required to provide informed consent and comply with follow-up protocols.

Why it matters

Who can join: the full rules

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

Where it's running

• Ascendis Investigational Site
  Phoenix, Arizona, United States Recruiting
• Ascendis Investigational Site
  Orange, California, United States Recruiting
• Ascendis Investigational Site
  Sacramento, California, United States Recruiting
• Ascendis Investigational Site
  San Francisco, California, United States Recruiting
• Ascendis Pharma Investigational Site
  Centennial, Colorado, United States Recruiting
• Ascendis Investigational Site
  Washington D.C., District of Columbia, United States Recruiting

Study contacts

• Study coordinator: Deborah Bowlby
• Email: SkyPASS_Contact@ascendispharma.com
• Phone: +1 844-442-7236

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.