Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients

Recruiting now

Conditions studied: FGF23-related Hypophosphataemic Rickets and Osteomalacia

In brief

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

Key facts

Study ID

NCT06202027

Run by

Kyowa Kirin Korea Co., Ltd.

People needed

100

Starts

2023-08-11

Expected to finish

2031-07-16

Last updated by the study team

2025-08-29

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have been started on CRYSVITA® in accordance with the approved label in Korea
• Those (or his/her legal guardian) who have agreed in writing to participate in the survey. Children who have obtained a written consent of his/her legal guardian about participation in this survey. In case of pediatric patient, explain sufficiently what you think the patient can understand. In this case, the legal guardian may provide supplementary explanations of the survey.

You may not qualify if…

• Patients for whom Burosumab is contraindicated according local label of CRYSVITA®
• Patients who intend to use this drug for other purposes
• Patients who participated in pre-market clinical trials with CRYSVITA® (Consecutive investigation method ONLY)
• Patients who have been taking this drug before the starting day of this study (Consecutive investigation method ONLY)

Where it is running

• Wonju Severance Christian Hospital — Wŏnju, Gangwon-do, South Korea (enrolling)
• Ajou University Hospital — Suwon, Gyeonggi-do, South Korea (enrolling)
• Yangsan Pusan National University Hospital — Yangsan, Gyeongsangnam-do, South Korea (enrolling)
• Chonnam National University Hospital — Gwangju, Jeollanam-do, South Korea (enrolling)
• Chungnam National University Sejong Hospital — Sejong, Sejong Special Self-Governing City, South Korea (enrolling)
• Inje University Busan Paik Hospital — Busan, South Korea (enrolling)
• Pusan National University Hospital — Busan, South Korea (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)
• Severance Hospital — Seoul, South Korea (enrolling)
• Severance Hospital — Seoul, South Korea (enrolling)
• Korea University Guro Hospital — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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