Actively Recruiting

Age: 1Year - 18Years
All Genders
NCT05775523

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

Led by Ascendis Pharma Endocrinology Division A/S · Updated on 2026-02-04

500

Participants Needed

27

Research Sites

519 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 1Year - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pediatric patients with growth hormone deficiency (GHD) treated with lonapegsomatropin
  • Patients clinically managed in Europe or the USA
  • Appropriate written informed consent or assent obtained based on patient age
  • Patients willing to comply with study follow-up requirements
Not Eligible

You will not qualify if you...

  • Participation in any interventional clinical trial for short stature
  • Treatment with growth hormone (GH) or IGF-1 therapy other than lonapegsomatropin at enrollment
  • Contraindication to lonapegsomatropin treatment
  • Closed growth plates (epiphyses)
  • Presence of active malignant tumors
  • Antitumor therapy within 12 months before starting GH therapy
  • Hypersensitivity to somatropin or any excipients in lonapegsomatropin

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 27 locations

1

Ascendis Investigational Site

Phoenix, Arizona, United States, 85054

Actively Recruiting

2

Ascendis Investigational Site

Orange, California, United States, 92868

Actively Recruiting

3

Ascendis Investigational Site

Sacramento, California, United States, 95821

Actively Recruiting

4

Ascendis Investigational Site

San Francisco, California, United States, 94143

Actively Recruiting

5

Ascendis Pharma Investigational Site

Centennial, Colorado, United States, 80112

Actively Recruiting

6

Ascendis Investigational Site

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

7

Ascendis Investigational Site

Orlando, Florida, United States, 32806

Actively Recruiting

8

Ascendis Investigational Site

Orlando, Florida, United States, 32827

Actively Recruiting

9

Ascendis Investigational Site

Tampa, Florida, United States, 33612

Actively Recruiting

10

Ascendis Investigational Site

Sandy Springs, Georgia, United States, 30350

Actively Recruiting

11

Ascendis Investigational Site

Boise, Idaho, United States, 83712

Actively Recruiting

12

Ascendis Investigational Site

Indianapolis, Indiana, United States, 46202

Actively Recruiting

13

Ascendis Investigational Site

Iowa City, Iowa, United States, 52242

Actively Recruiting

14

Ascendis Investigational Site

Louisville, Kentucky, United States, 40202

Actively Recruiting

15

Ascendis Investigational Site

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

16

Ascendis Investigational Site

Las Vegas, Nevada, United States, 89113

Actively Recruiting

17

Ascendis Investigational Site

Lebanon, New Hampshire, United States, 03756

Actively Recruiting

18

Ascendis Investigational Site

Manchester, New Hampshire, United States, 03104

Actively Recruiting

19

Ascendis Investigational Site

Morristown, New Jersey, United States, 07960

Actively Recruiting

20

Ascendis Investigational Site

New Hyde Park, New York, United States, 11042

Actively Recruiting

21

Ascendis Investigational Site

Cincinnati, Ohio, United States, 45229

Actively Recruiting

22

Ascendis Investigational Site

Portland, Oregon, United States, 97239

Actively Recruiting

23

Ascendis Investigational Site

Columbia, South Carolina, United States, 29203

Actively Recruiting

24

Ascendis Investigational Site

Dallas, Texas, United States, 75390

Actively Recruiting

25

Ascendis Investigational Site

El Paso, Texas, United States, 79907

Actively Recruiting

26

Ascendis Investigational Site

Norfolk, Virginia, United States, 23507

Actively Recruiting

27

Ascendis Investigational Site

Seattle, Washington, United States, 98105

Actively Recruiting

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Research Team

D

Deborah Bowlby

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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