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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FGF23-related hypophosphataemic rickets and osteomalacia | Drug | FGF23-related hypophosphataemic rickets and osteomalacia |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks after follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Phosphorus Concentration | 1) Change from baseline over time in Serum Phosphorus Concentration (mg/dL), up to Week 24 | 24 weeks |
| 1,25-Dihydroxyvitamin D | 2) Change from baseline over time in 1,25-Dihydroxyvitamin D, up to Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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FGF23-related hypophosphataemic rickets and osteomalacia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HaeMi Park | Contact | +82-10-3378-3471 | haemi.park.m8@kyowakirin.com |
| Name | Affiliation | Role |
|---|---|---|
| HaeMi Park | Kyowa Kirin Korea Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonju Severance Christian Hospital | Recruiting | Wŏnju | Gangwon-do | 26426 | South Korea |
Undecided
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| 24 weeks |
| Ajou University Hospital | Recruiting | Suwon | Gyeonggi-do | 16499 | South Korea |
|
| Yangsan Pusan National University Hospital | Recruiting | Yangsan | Gyeongsangnam-do | 50612 | South Korea |
|
| Chonnam National University Hospital | Recruiting | Gwangju | Jeollanam-do | 61469 | South Korea |
|
| Chungnam National University Sejong Hospital | Recruiting | Sejong | Sejong Special Self-Governing City | 30099 | South Korea |
|
| Inje University Busan Paik Hospital | Recruiting | Busan | 47392 | South Korea |
|
| Pusan National University Hospital | Recruiting | Busan | 49241 | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
|
| Severance Hospital | Recruiting | Seoul | 03722 | South Korea |
|
| Severance Hospital | Recruiting | Seoul | 03722 | South Korea |
|
| Korea University Guro Hospital | Recruiting | Seoul | 08308 | South Korea |
|
| ID | Term |
|---|---|
| D010018 | Osteomalacia |
| ID | Term |
|---|---|
| D012279 | Rickets |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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