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

Part of paid clinical trials in Phoenix, Arizona.

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

  • Growth Hormone Deficiency

Eligibility Criteria

Sex
ALL
Age
1 Year - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • No intervention — DRUG
    No intervention

Study Details

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.

Key Dates

First listed
Mar 20, 2023
Start date
Mar 20, 2023
Status verified
Feb 2026
Primary completion
Mar 31, 2033
Completion
Mar 31, 2033

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Patients on SKYTROFA (Lonapegsomatropin)Treatment
    SKYTROFA (Lonapegsomatropin) administered once-weekly by subcutaneous injection

Primary Outcome Measure

Occurrence of neoplasms (benign, malignant and unspecified) [ Time Frame: 5 years ]

Central Contacts

Locations (27)

FacilityCityStateZIPSite coordinators
Ascendis Investigational SitePhoenixArizona85054-
Ascendis Investigational SiteOrangeCalifornia92868-
Ascendis Investigational SiteSacramentoCalifornia95821-
Ascendis Investigational SiteSan FranciscoCalifornia94143-
Ascendis Pharma Investigational SiteCentennialColorado80112-
Ascendis Investigational SiteWashington D.C.District of Columbia20010-
Ascendis Investigational SiteOrlandoFlorida32806-
Ascendis Investigational SiteOrlandoFlorida32827-
Ascendis Investigational SiteTampaFlorida33612-
Ascendis Investigational SiteSandy SpringsGeorgia30350-
Ascendis Investigational SiteBoiseIdaho83712-
Ascendis Investigational SiteIndianapolisIndiana46202-
Ascendis Investigational SiteIowa CityIowa52242-
Ascendis Investigational SiteLouisvilleKentucky40202-
Ascendis Investigational SiteMinneapolisMinnesota55455-
Ascendis Investigational SiteLas VegasNevada89113-
Ascendis Investigational SiteLebanonNew Hampshire03756-
Ascendis Investigational SiteManchesterNew Hampshire03104-
Ascendis Investigational SiteMorristownNew Jersey07960-
Ascendis Investigational SiteNew Hyde ParkNew York11042-
Ascendis Investigational SiteCincinnatiOhio45229-
Ascendis Investigational SitePortlandOregon97239-
Ascendis Investigational SiteColumbiaSouth Carolina29203-
Ascendis Investigational SiteDallasTexas75390-
Ascendis Investigational SiteEl PasoTexas79907-
Ascendis Investigational SiteNorfolkVirginia23507-
Ascendis Investigational SiteSeattleWashington98105-

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By research site
Ascendis Investigational Site· Phoenix, AZAscendis Investigational Site· Orange, CAAscendis Investigational Site· Sacramento, CAAscendis Investigational Site· San Francisco, CAAscendis Pharma Investigational Site· Centennial, COAscendis Investigational Site· Washington D.C., DC

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