Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
1 other identifier
observational
100
1 country
13
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2023
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 11, 2023
CompletedFirst Submitted
Initial submission to the registry
January 2, 2024
CompletedFirst Posted
Study publicly available on registry
January 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 16, 2031
August 29, 2025
August 1, 2025
7.9 years
January 2, 2024
August 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Serum Phosphorus Concentration
24 weeks
1,25-Dihydroxyvitamin D
24 weeks
Interventions
FGF23-related hypophosphataemic rickets and osteomalacia
Eligibility Criteria
FGF23-related hypophosphataemic rickets and osteomalacia
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, 16499, South Korea
Yangsan Pusan National University Hospital
Yangsan, Gyeongsangnam-do, 50612, South Korea
Chonnam National University Hospital
Gwangju, Jeollanam-do, 61469, South Korea
Chungnam National University Sejong Hospital
Sejong, Sejong Special Self-Governing City, 30099, South Korea
Inje University Busan Paik Hospital
Busan, 47392, South Korea
Pusan National University Hospital
Busan, 49241, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Severance Hospital
Seoul, 03722, South Korea
Severance Hospital
Seoul, 03722, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
HaeMi Park
Kyowa Kirin Korea Co., Ltd.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Weeks
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2024
First Posted
January 11, 2024
Study Start
August 11, 2023
Primary Completion (Estimated)
June 16, 2031
Study Completion (Estimated)
July 16, 2031
Last Updated
August 29, 2025
Record last verified: 2025-08