A Study of KRN23 in Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia

X-linked Hypophosphatemic Rickets/Osteomalacia Clinical Trial

Official title: A Phase 3 Open-Label Trial to Assess the Efficacy and Safety of KRN23 in Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia and a Postmarketing Study of KRN23 Switched From the Phase 3 Trial

Status Completed

Clinical Trial Summary

Before switching to the post-marketing study:

To evaluate the efficacy and safety of KRN23 administered subcutaneously once every 2 weeks in children with X-linked hypophosphatemic rickets/osteomalacia(XLH).

After switching to the post-marketing study:

To evaluate the safety and efficacy of KRN23, which is switched from the investigational product to the post-marketing study drug, at the approved dose and dosing regimen in subjects who continue treatment

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Familial Hypophosphatemic Rickets
• Osteomalacia
• Rickets
• X-linked Hypophosphatemic Rickets/Osteomalacia

• NCT number: NCT03233126
• Study type: Interventional
• Source: Kyowa Kirin Co., Ltd.
• Status: Completed
• Phase: Phase 3
• Start date: July 6, 2017
• Completion date: February 17, 2020