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

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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