Status:
RECRUITING
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
Lead Sponsor:
Kyowa Kirin Korea Co., Ltd.
Conditions:
FGF23-related Hypophosphataemic Rickets and Osteomalacia
Eligibility:
All Genders
1+ years
Brief Summary
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
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
August 11 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 16 2031
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06202027
Start Date
August 11 2023
End Date
July 16 2031
Last Update
August 29 2025
Active Locations (13)
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1
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea, 26426
2
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea, 16499
3
Yangsan Pusan National University Hospital
Yangsan, Gyeongsangnam-do, South Korea, 50612
4
Chonnam National University Hospital
Gwangju, Jeollanam-do, South Korea, 61469