NCT06202027 Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
| NCT ID | NCT06202027 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kyowa Kirin Korea Co., Ltd. |
| Condition | FGF23-related Hypophosphataemic Rickets and Osteomalacia |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-08-11 |
| Primary Completion | 2031-06-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-08-11 with a primary completion date of 2031-06-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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)
Contact & Investigator
Hyejin Noh
STUDY DIRECTOR
Kyowa Kirin Korea Co., Ltd.
Frequently Asked Questions
Who can join the NCT06202027 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, studying FGF23-related Hypophosphataemic Rickets and Osteomalacia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06202027 currently recruiting?
Yes, NCT06202027 is actively recruiting participants. Contact the research team at hyejin.noh.2u@kyowakirin.com for enrollment information.
Where is the NCT06202027 trial being conducted?
This trial is being conducted at Wŏnju, South Korea, Suwon, South Korea, Yangsan, South Korea, Gwangju, South Korea and 9 additional locations.
Who is sponsoring the NCT06202027 clinical trial?
NCT06202027 is sponsored by Kyowa Kirin Korea Co., Ltd.. The principal investigator is Hyejin Noh at Kyowa Kirin Korea Co., Ltd.. The trial plans to enroll 100 participants.