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Clinical Trials in South Korea / NCT06202027
Recruiting Observational

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

NCT06202027 · tracked via the Priya Life Science South Korea tracker
Sponsor
Kyowa Kirin Korea Co., Ltd
Phase
Observational
Started
2023-08-11
Last updated
2025-08-29

Condition(s) studied

FGF23-related Hypophosphataemic Rickets and Osteomalacia

Investigational drug(s) / intervention(s)

FGF23-related hypophosphataemic rickets and osteomalacia

FGF23-related hypophosphataemic rickets and osteomalacia: FGF23-related hypophosphataemic rickets and osteomalacia

Study 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

Sex
ALL
Min age
1 Day
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients who have been started on CRYSVITA® in accordance with the approved label in Korea 2. 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 Criteria: 1. Patients for whom Burosumab is contraindicated according local label of CRYSVITA® 2. Patients who intend to use this drug for other purposes 3. Patients who participated in pre-market clinical trials with CRYSVITA® (Consecutive investigation method ONLY) 4. Patients who have been taking this drug before the starting day of this study (Consecutive investigation method ONLY)

Primary outcome measure(s)

  • safety (Special situation, adverse event, symptom, or disease occuring during treatment with a drug) — 4 weeks after follow up
    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

Trial sites (13)

FacilityCityRegionStatus
Wonju Severance Christian Hospital Wŏnju Gangwon-do Recruiting
Ajou University Hospital Suwon Gyeonggi-do Recruiting
Yangsan Pusan National University Hospital Yangsan Gyeongsangnam-do Recruiting
Chonnam National University Hospital Gwangju Jeollanam-do Recruiting
Chungnam National University Sejong Hospital Sejong Sejong Special Self-Governing City Recruiting
Inje University Busan Paik Hospital Busan South Korea Recruiting
Pusan National University Hospital Busan South Korea Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Severance Hospital Seoul South Korea Recruiting
Severance Hospital Seoul South Korea Recruiting
Korea University Guro Hospital Seoul South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06202027 on ClinicalTrials.gov ↗ ← All trials in South Korea