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NCT05775523Recruiting

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

Ascendis Pharma Endocrinology Division A/S

Start Date

3/20/2023

Completion Date

3/1/2033

Summary

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.

Eligibility Criteria

Age Range: 1 years to 18 years

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

Interventions

DRUG

No intervention

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Conditions

Growth Hormone Deficiency

Locations

Ascendis Investigational Site

Phoenix, Arizona 85054

United States

Ascendis Investigational Site

Orange, California 92868

United States

Ascendis Investigational Site

Sacramento, California 95821

United States

Ascendis Investigational Site

San Francisco, California 94143

United States

Ascendis Pharma Investigational Site

Centennial, Colorado 80112

United States

Ascendis Investigational Site

Washington D.C., District of Columbia 20010

United States

Ascendis Investigational Site

Orlando, Florida 32806

United States

Ascendis Investigational Site

Orlando, Florida 32827

United States

Ascendis Investigational Site

Tampa, Florida 33612

United States

Ascendis Investigational Site

Sandy Springs, Georgia 30350

United States

Ascendis Investigational Site

Boise, Idaho 83712

United States

Ascendis Investigational Site

Indianapolis, Indiana 46202

United States

Ascendis Investigational Site

Iowa City, Iowa 52242

United States

Ascendis Investigational Site

Louisville, Kentucky 40202

United States

Ascendis Investigational Site

Minneapolis, Minnesota 55455

United States

Ascendis Investigational Site

Las Vegas, Nevada 89113

United States

Ascendis Investigational Site

Lebanon, New Hampshire 03756

United States

Ascendis Investigational Site

Manchester, New Hampshire 03104

United States

Ascendis Investigational Site

Morristown, New Jersey 07960

United States

Ascendis Investigational Site

New Hyde Park, New York 11042

United States

Ascendis Investigational Site

Cincinnati, Ohio 45229

United States

Ascendis Investigational Site

Portland, Oregon 97239

United States

Ascendis Investigational Site

Columbia, South Carolina 29203

United States

Ascendis Investigational Site

Dallas, Texas 75390

United States

Ascendis Investigational Site

El Paso, Texas 79907

United States

Ascendis Investigational Site

Norfolk, Virginia 23507

United States

Ascendis Investigational Site

Seattle, Washington 98105

United States