Observing the safety and effectiveness of CRYSVITA in South Korean patients

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

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
• Enrollment: 100 (estimated)
• Ages: 1 Day and up
• Sex: All
• Sponsor: Kyowa Kirin Co., Ltd. (Industry-sponsored)
• Drugs / interventions: Burosumab
• Locations: 13 sites (Wŏnju, Gangwon-do and 12 other locations)
• Trial ID: NCT06202027 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are patients who have been prescribed CRYSVITA in accordance with the approved label in Korea.

Not a fit: Patients who are contraindicated for Burosumab or those using the drug for unapproved purposes may not benefit from this study.

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 performed: Other studies on post-marketing surveillance of similar treatments have shown success in monitoring safety and effectiveness, making this approach well-established.

Eligibility 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 this trial is running

Wŏnju, Gangwon-do and 12 other locations

• 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)
• 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: HaeMi Park

Conditions FGF23-related Hypophosphataemic Rickets and Osteomalacia