Status and phase
Conditions
Treatments
About
Before switching to the post-marketing study:
Assess the efficacy and safety of KRN23 administered subcutaneously once every 4 or 2 weeks in adult or children with XLH
After switching to the post-marketing study:
To evaluate the safety and efficacy of KRN23, which was switched from the investigational product to the post-marketing investigational product, at the approved dose and dosing regimen in subjects who continued treatment
Enrollment
Sex
Volunteers
Inclusion criteria
Personally submitted voluntary written informed consent to participate in the study; For pediatric patients, personally submitted voluntary written informed consent by a legally authorized representative.
If appropriate, written or verbal assent to participate in the study should be obtained from patients.
Patients meeting any of the followings;
For female patients; women of childbearing potential (except for females who have not reached menarche, permanently sterilized, postmenopausal [12 months with no menses without an alternative medical cause] or anatomically not of childbearing potential) with negative pregnancy test at pre-treatment assessment of Week 0
For female patient with childbearing potential, or male patients with reproductive capacity; willingness to use acceptable methods of contraception while participating in the study
Willingness and ability to cooperatively complete all study procedures, adhere to the visit schedule and follow the investigator's instructions, as considered by investigator or subinvestigator
Exclusion criteria
At the time of switching to the post-marketing clinical study:
Subjects eligible for enrollment in the post-marketing clinical study must have met both of the following criteria:
Primary purpose
Allocation
Interventional model
Masking
27 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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