Recruiting NCT06202027
Post Marketing Surveillance Study to Observe Safety and Effectiveness of CRYSVITA® in S. Korean Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FGF23-related hypophosphataemic rickets and osteomalacia.
- Who it may be relevant to
- Registry conditions: FGF23-related Hypophosphataemic Rickets and Osteomalacia. Basic parameters: from 1 Day · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- Drug FGF23-related hypophosphataemic rickets and osteomalacia
FGF23-related hypophosphataemic rickets and osteomalacia
Primary outcome measures
- safety (Special situation, adverse event, symptom, or disease occuring during treatment with a drug) [Time frame: 4 weeks after follow up]
Secondary outcome measures (2)
- Serum Phosphorus Concentration [Time frame: 24 weeks]
- 1,25-Dihydroxyvitamin D [Time frame: 24 weeks]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
South Korea · 13 centers
- Wonju Severance Christian Hospital — Wŏnju
- Ajou University Hospital — Suwon
- Yangsan Pusan National University Hospital — Yangsan
- Chonnam National University Hospital — Gwangju
- Chungnam National University Sejong Hospital — Sejong
- Inje University Busan Paik Hospital — Busan
- Pusan National University Hospital — Busan
- Seoul National University Hospital — Seoul
- … and 5 more centers
Identifiers
NCT: NCT06202027 · CRYSVITA PMS