The objective of this post-marketing surveillance (PMS) study is to assess the safety and effectiveness of CRYSVITA injection 10, 20, and 30mg, equivalent to in routine clinical settings
Study Type
OBSERVATIONAL
Enrollment
100
FGF23-related hypophosphataemic rickets and osteomalacia
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea
RECRUITINGAjou University Hospital
Suwon, Gyeonggi-do, South Korea
safety (Special situation, adverse event, symptom, or disease occuring during treatment with a drug)
Investigators have to record all events (i.e., all AEs and special situations) in CRFs including undesirable medical findings obtained during the medical examination as well as spontaneous reports from subjects. All AEs occurring for at least 4 weeks after the last dose of CRYSVITA® should be included in this study
Time frame: 4 weeks after follow up
Serum Phosphorus Concentration
1\) Change from baseline over time in Serum Phosphorus Concentration (mg/dL), up to Week 24
Time frame: 24 weeks
1,25-Dihydroxyvitamin D
2\) Change from baseline over time in 1,25-Dihydroxyvitamin D, up to Week 24
Time frame: 24 weeks
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Yangsan Pusan National University Hospital
Yangsan, Gyeongsangnam-do, South Korea
RECRUITINGChonnam National University Hospital
Gwangju, Jeollanam-do, South Korea
RECRUITINGChungnam National University Sejong Hospital
Sejong, Sejong Special Self-Governing City, South Korea
RECRUITINGInje University Busan Paik Hospital
Busan, South Korea
RECRUITINGPusan National University Hospital
Busan, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITING...and 3 more locations