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

Recruiting

• Conditions: FGF23-related Hypophosphataemic Rickets and Osteomalacia

• Registration Number: NCT06202027
• Lead Sponsor: Kyowa Kirin Korea Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-11
• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-02
• Study First Posted: 2024-01-11
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-29
• Primary Completion: 2031-06-16
• Study Completion: 2031-07-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Serum Phosphorus Concentration	24 weeks	1) Change from baseline over time in Serum Phosphorus Concentration (mg/dL), up to Week 24
1,25-Dihydroxyvitamin D	24 weeks	2) Change from baseline over time in 1,25-Dihydroxyvitamin D, up to Week 24

Trial Locations

Locations (1)

Choi Hyeokjun; 🇰🇷 Seoul, Korea, Republic of