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

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Kyowa Kirin

Status

Enrolling

Conditions

FGF23-related Hypophosphataemic Rickets and Osteomalacia

Treatments

Drug: FGF23-related hypophosphataemic rickets and osteomalacia

Study type

Observational

Funder types

Industry

Identifiers

NCT06202027
CRYSVITA PMS

Details and patient eligibility

About

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

Enrollment

100 estimated patients

Sex

All

Ages

1+ day old

Volunteers

No Healthy Volunteers

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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