Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-03-05 @ 9:48 AM
Study NCT ID:
NCT02526160
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2015-07-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH)
Sponsor:
Kyowa Kirin, Inc.
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study With Open-Label Extension to Assess the Efficacy and Safety of KRN23 in Adults With X-linked Hypophosphatemia (XLH)
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03775187
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
Brief Summary:
The primary efficacy objective of this study is to establish the effect of burosumab treatment compared with placebo on increasing serum phosphorus levels in adults with XLH.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2014-005529-11 | EUDRACT_NUMBER | None | View |