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

Kyowa Kirin Korea Co., Ltd.10 sites in 1 country100 target enrollmentAugust 11, 2023

ConditionsFGF23-related Hypophosphataemic Rickets and Osteomalacia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: FGF23-related Hypophosphataemic Rickets and Osteomalacia
Sponsor: Kyowa Kirin Korea Co., Ltd.
Enrollment: 100
Locations: 10
Primary Endpoint: safety (Special situation, adverse event, symptom, or disease occuring during treatment with a drug)
Status: Recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

August 11, 2023

End Date

July 16, 2031

Last Updated

8 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Kyowa Kirin Korea Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients who have been started on CRYSVITA® in accordance with the approved label in Korea
•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

•Patients for whom Burosumab is contraindicated according local label of CRYSVITA®
•Patients who intend to use this drug for other purposes
•Patients who participated in pre-market clinical trials with CRYSVITA® (Consecutive investigation method ONLY)
•Patients who have been taking this drug before the starting day of this study (Consecutive investigation method ONLY)

Outcomes

Primary Outcomes

safety (Special situation, adverse event, symptom, or disease occuring during treatment with a drug)

Time Frame: 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