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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06202027

Enrollment

100

Registered

2024-01-11

Start date

2023-08-11

Completion date

2031-07-16

Last updated

2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

FGF23-related Hypophosphataemic Rickets and Osteomalacia

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

Interventions

DRUGFGF23-related hypophosphataemic rickets and osteomalacia

FGF23-related hypophosphataemic rickets and osteomalacia

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

South Korea

Contacts

Primary ContactHaeMi Park

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026