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Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)

NCT02537431 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-06-18

Study results available
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Summary

The primary objective of this study is to establish the effect of KRN23 treatment on improvement in XLH-associated osteomalacia as determined by osteoid volume (osteoid volume/bone volume, OV/BV).

Conditions

  • X-linked Hypophosphatemia

Interventions

BIOLOGICAL

burosumab

solution for subcutaneous injection

Sponsors & Collaborators

  • Kyowa Kirin Co., Ltd.

    collaborator INDUSTRY

  • Kyowa Kirin, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-23
Primary Completion
2017-08-30
Completion
2018-12-13
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Denmark
  • France
  • Japan
  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02537431 on ClinicalTrials.gov