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

August 28, 2025 updated by: Kyowa Kirin Korea Co., Ltd.
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Busan, South Korea, 49241
        • Recruiting
        • Pusan National University Hospital
        • Contact:
        • Principal Investigator:
          • Hayoung Cho
      • Busan, South Korea, 47392
        • Recruiting
        • Inje University Busan Paik Hospital
        • Contact:
        • Principal Investigator:
          • Boryeon Lee
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Seungsin Park
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital
        • Contact:
        • Principal Investigator:
          • YuMi Lee
      • Seoul, South Korea, 08308
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
        • Principal Investigator:
          • Hyokyung Nam
    • Gangwon-do
      • Wŏnju, Gangwon-do, South Korea, 26426
        • Recruiting
        • Wonju Severance Christian Hospital
        • Contact:
        • Principal Investigator:
          • YongHyuk Kim
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, South Korea, 16499
        • Recruiting
        • Ajou University Hospital
        • Contact:
        • Principal Investigator:
          • Hae Sang Lee
    • Gyeongsangnam-do
      • Yangsan, Gyeongsangnam-do, South Korea, 50612
        • Recruiting
        • Yangsan Pusan National University Hospital
        • Contact:
        • Principal Investigator:
          • JongKun Jeon
    • Jeollanam-do
      • Gwangju, Jeollanam-do, South Korea, 61469
        • Recruiting
        • Chonnam National University Hospital
        • Principal Investigator:
          • Eunmi Yang
        • Contact:
    • Sejong Special Self-Governing City
      • Sejong, Sejong Special Self-Governing City, South Korea, 30099
        • Recruiting
        • Chungnam National University Sejong Hospital
        • Contact:
        • Principal Investigator:
          • YuMi Kim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

FGF23-related hypophosphataemic rickets and osteomalacia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks after follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Phosphorus Concentration
Time Frame: 24 weeks
1) Change from baseline over time in Serum Phosphorus Concentration (mg/dL), up to Week 24
24 weeks
1,25-Dihydroxyvitamin D
Time Frame: 24 weeks
2) Change from baseline over time in 1,25-Dihydroxyvitamin D, up to Week 24
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Korea Co., Ltd.

Investigators

  • Study Director: HaeMi Park, Kyowa Kirin Korea Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2023

Primary Completion (Estimated)

June 16, 2031

Study Completion (Estimated)

July 16, 2031

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 2, 2024

First Posted (Actual)

January 11, 2024

Study Record Updates

Last Update Posted (Estimated)

August 29, 2025

Last Update Submitted That Met QC Criteria

August 28, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRYSVITA PMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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