Trials / Completed
CompletedNCT02750618
Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)
An Open-Label, Phase 2 Study to Assess the Safety, Pharmacodynamics, and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Kyowa Kirin, Inc. · Industry
- Sex
- All
- Age
- 1 Year – 4 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of the study are to: * Establish the safety profile of KRN23 for the treatment of XLH in children between 1 and 4 years old * Determine the PD effects of KRN23 treatment on serum phosphorus and other PD markers that reflect the status of phosphate homeostasis in children between 1 and 4 years old with XLH
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Burosumab | solution for subcutaneous injection |
Timeline
- Start date
- 2016-05-05
- Primary completion
- 2017-04-20
- Completion
- 2019-09-10
- First posted
- 2016-04-25
- Last updated
- 2024-05-06
- Results posted
- 2018-06-19
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02750618. Inclusion in this directory is not an endorsement.