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

Purpose

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.

Condition

  • Growth Hormone Deficiency

Eligibility

Eligible Ages
Between 1 Year and 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Patients on SKYTROFA (Lonapegsomatropin)Treatment SKYTROFA (Lonapegsomatropin) administered once-weekly by subcutaneous injection
  • Drug: No intervention
    No intervention

Recruiting Locations

Ascendis Investigational Site
Phoenix 5308655, Arizona 5551752 85054

Ascendis Investigational Site
Orange 5379513, California 5332921 92868

Ascendis Investigational Site
Sacramento 5389489, California 5332921 95821

Ascendis Investigational Site
San Francisco 5391959, California 5332921 94143

Ascendis Pharma Investigational Site
Centennial 5416541, Colorado 5417618 80112

Ascendis Investigational Site
Washington D.C. 4140963, District of Columbia 4138106 20010

Ascendis Investigational Site
Orlando 4167147, Florida 4155751 32806

Ascendis Investigational Site
Orlando 4167147, Florida 4155751 32827

Ascendis Investigational Site
Tampa 4174757, Florida 4155751 33612

Ascendis Investigational Site
Sandy Springs 4221333, Georgia 4197000 30350

Ascendis Investigational Site
Boise 5586437, Idaho 5596512 83712

Ascendis Investigational Site
Indianapolis 4259418, Indiana 4921868 46202

Ascendis Investigational Site
Iowa City 4862034, Iowa 4862182 52242

Ascendis Investigational Site
Louisville 4299276, Kentucky 6254925 40202

Ascendis Investigational Site
Minneapolis 5037649, Minnesota 5037779 55455

Ascendis Investigational Site
Las Vegas 5506956, Nevada 5509151 89113

Ascendis Investigational Site
Lebanon 5088597, New Hampshire 5090174 03756

Ascendis Investigational Site
Manchester 5089178, New Hampshire 5090174 03104

Ascendis Investigational Site
Morristown 5101427, New Jersey 5101760 07960

Ascendis Investigational Site
New Hyde Park 5128514, New York 5128638 11042

Ascendis Investigational Site
Cincinnati 4508722, Ohio 5165418 45229

Ascendis Investigational Site
Portland 5746545, Oregon 5744337 97239

Ascendis Investigational Site
Columbia 4575352, South Carolina 4597040 29203

Ascendis Investigational Site
Dallas 4684888, Texas 4736286 75390

Ascendis Investigational Site
El Paso 5520993, Texas 4736286 79907

Ascendis Investigational Site
Norfolk 4776222, Virginia 6254928 23507

Ascendis Investigational Site
Seattle 5809844, Washington 5815135 98105

More Details

NCT ID
NCT05775523
Status
Recruiting
Sponsor
Ascendis Pharma Endocrinology Division A/S

Study Contact

Deborah Bowlby
+1 844-442-7236
SkyPASS_Contact@ascendispharma.com

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center