Trials / Completed
CompletedNCT02537431
Open Label Study of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)
An Open-Label, Single-Arm, Phase 3 Study to Evaluate the Effects of KRN23 on Osteomalacia in Adults With X-linked Hypophosphatemia (XLH)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 14 (actual)
- Sponsor
- Kyowa Kirin, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | burosumab | solution for subcutaneous injection |
Timeline
- Start date
- 2015-12-23
- Primary completion
- 2017-08-30
- Completion
- 2018-12-13
- First posted
- 2015-09-01
- Last updated
- 2024-06-18
- Results posted
- 2018-09-25
Locations
14 sites across 6 countries: United States, Canada, Denmark, France, Japan, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02537431. Inclusion in this directory is not an endorsement.