Non-Interventional Post-Authorization Study of Patients Treated with SKYTROFA (SkyPASS)

Condition: Growth Hormone Deficiency (GHD)

Type of Research: Prospective
Principal Investigator: Kent Reifschneider, MD

Study Specifications: The overall goal of this study is to evaluate any potential long-term safety risks of SKYTROFA in patients under real-world conditions, post-market.
Phone: (757) 668-5416

Safety Study for Patients Treated with SKYTROFA (SkybriGHt)

Condition: Growth Hormone Deficiency (GHD)

Type of Research: Retrospective
Principal Investigator
: Kent Reifschneider, MD

Study Specifications: Growth Hormone Deficiency (GHD) is diagnosed from inadequate body secretion of growth hormone from the anterior pituitary gland. GHD can be either congenital or acquired later in life from several reasons including (but limited to) trauma or infection. GHD will lead to growth retardation and maturation delays due to disproportionate bone growth to age of the child. This study will evaluate long-term outcomes of treatment with Skytrofa in patients previously enrolled and receiving this drug in the Sponsor trial under clinical development.
Phone: (757) 668-5416

XLH-Disease Monitoring Program (DMP)

Condition: X-Linked Hypophosphatemia (XLH)

Type of Research: Observational
Principal Investigator: Eric Gyuricsko, MD

Study Specifications: XLH (Rickets) is a rare, chronic genetic disorder that represents an unmet medical need. Burosumab (Crysvita®) met FDA approval in 2018 for adult and pediatric patients over the age of one. XLH-DMP is a long-term study aiming to collect pertinent information on adult and pediatric patients with XLH that have/have not participated in Burosumab clinical trials. XLH-DMP aims to monitor patients for 10 years, to assess the safety and efficacy of Burosumab while also monitoring the progression of XLH without treatment.
Phone: (757) 668-5416