Observing the safety and effectiveness of CRYSVITA in South Korean patients
Official title: Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
Run by Kyowa Kirin Co., Ltd. · NCT06202027 · Data updated 2026-11-12
This study is looking at how safe and effective CRYSVITA injections are for South Korean patients with a specific type of bone disease who are already receiving the treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 1 Day and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Kyowa Kirin Co., Ltd. Industry-sponsored |
| Drugs / interventions | Burosumab |
| Locations | 13 sites (Wŏnju, Gangwon-do and 12 other locations) |
| Status | Recruiting |
| Started | August 11, 2023 |
| Main results expected | June 16, 2031 |
| Study ends | July 16, 2031 |
| Registry record updated | November 2, 2026 |
| Trial ID | NCT06202027 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are patients who have been prescribed CRYSVITA in accordance with the approved label in Korea.
✕Probably not a fit
Patients who are contraindicated for Burosumab or those using the drug for unapproved purposes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to monitor the safety and effectiveness of CRYSVITA injections in patients diagnosed with FGF23-related hypophosphataemic rickets and osteomalacia in South Korea. It will involve patients who have already started treatment with CRYSVITA according to the approved guidelines. The study will collect data on patient outcomes in routine clinical settings to ensure the drug's ongoing safety and efficacy.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of CRYSVITA for patients with specific bone disorders.
How similar studies have gone: Other studies on post-marketing surveillance of similar treatments have shown success in monitoring safety and effectiveness, making this approach well-established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
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Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, South Korea Recruiting -
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea Recruiting -
Yangsan Pusan National University Hospital
Yangsan, Gyeongsangnam-do, South Korea Recruiting -
Chonnam National University Hospital
Gwangju, Jeollanam-do, South Korea Recruiting -
Chungnam National University Sejong Hospital
Sejong, Sejong Special Self-Governing City, South Korea Recruiting -
Inje University Busan Paik Hospital
Busan, South Korea Recruiting
Show 7 more locations
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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
Study contacts
- Study coordinator: Hyejin Noh
- Email: hyejin.noh.2u@kyowakirin.com
- Phone: +82-10-3378-3471
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.