A US Non-interventional, Effectiveness and Safety Study of Patients Treated With SKYTROFA
Purpose
The goal of this study is to genrate evidence on long-term effectiveness and safety of SKYTROFA (lonapegsomatropin) in patients with growth hormone deficiency under routine clinical care
Condition
- Growth Hormone Deficiency
Eligibility
- Eligible Ages
- Between 1 Year and 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Patients who are on treatment with SKYTROFA (lonapegsomatropin) - Patients being clinically managed in USA - Patients with an appropriate written informed consent/assent as applicable for the age of the patient
Exclusion Criteria
- Patients participating in any interventional clinical study
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Patients on SKYTROFA Treatment | Patients on SKYTROFA Treatment managed in USA with appropriate written Informed Consent |
|
Recruiting Locations
Phoenix 5308655, Arizona 5551752 85054
Orange 5379513, California 5332921 92868
Sacramento 5389489, California 5332921 95821
San Francisco 5391959, California 5332921 94143
Centennial 5416541, Colorado 5417618 80112
Washington D.C. 4140963, District of Columbia 4138106 20010
Orlando 4167147, Florida 4155751 32806
Orlando 4167147, Florida 4155751 32827
Tampa 4174757, Florida 4155751 33612
Sandy Springs 4221333, Georgia 4197000 30350
Boise 5586437, Idaho 5596512 83712
Indianapolis 4259418, Indiana 4921868 46202
Iowa City 4862034, Iowa 4862182 52242
Louisville 4299276, Kentucky 6254925 40202
Minneapolis 5037649, Minnesota 5037779 55455
Las Vegas 5506956, Nevada 5509151 89113
Lebanon 5088597, New Hampshire 5090174 03756
Manchester 5089178, New Hampshire 5090174 03104
Morristown 5101427, New Jersey 5101760 07960
New Hyde Park 5128514, New York 5128638 11042
Cincinnati 4508722, Ohio 5165418 45229
Portland 5746545, Oregon 5744337 97239
Columbia 4575352, South Carolina 4597040 29203
Dallas 4684888, Texas 4736286 75390
El Paso 5520993, Texas 4736286 79907
Norfolk 4776222, Virginia 6254928 23507
Seattle 5809844, Washington 5815135 98105
More Details
- NCT ID
- NCT05820672
- Status
- Recruiting
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
Detailed Description
Patients will be treated according to routine clinical practice, and no additional visits, examinations or tests will be required beyond those performed as part of routine clinical practice except for COAs.