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Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients | Clinical Trials | Clareo Health

RECRUITING

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

NCT06202027•Kyowa Kirin Korea Co., Ltd.

View on ClinicalTrials.gov

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

Age

0 - No limit years

Sex

ALL

Healthy Volunteers

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)

Locations (13)

Wonju Severance Christian Hospital

Wŏnju, Gangwon-do, South Korea

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Yangsan Pusan National University Hospital

Yangsan, Gyeongsangnam-do, South Korea

Chonnam National University Hospital

Gwangju, Jeollanam-do, South Korea

Chungnam National University Sejong Hospital

Sejong, Sejong Special Self-Governing City, South Korea

Inje University Busan Paik Hospital

Busan, South Korea

Pusan National University Hospital

Busan, South Korea

Seoul National University Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Key Dates

Start Date

August 11, 2023

Primary Completion Date

June 16, 2031

Completion Date

July 16, 2031

Last Updated

August 29, 2025

Enrollment

100

ESTIMATED participants

Conditions

FGF23-related Hypophosphataemic Rickets and Osteomalacia

Interventions

FGF23-related hypophosphataemic rickets and osteomalacia

DRUG

Contacts

HaeMi Park

CONTACT

+82-10-3378-3471 haemi.park.m8@kyowakirin.com