Trials / Completed
CompletedNCT04842032
Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Pediatric Chinese Patients With XLH
An Open-label, Multi-center, Single-cohort, Post-marketing Phase 4 Study to Evaluate the Efficacy, Pharmacodynamics, and Safety of the Anti-FGF23 Antibody, KRN23, in Pediatric Chinese Patients With X-linked Hypophosphatemic Rickets/Osteomalacia (XLH)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Kyowa Kirin Co., Ltd. · Industry
- Sex
- All
- Age
- 1 Year – 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of KRN23 in pediatric Chinese patients with XLH
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KRN23 | KRN23 is a sterile clear colourless and preservative free solution supplied in single use 5 mL vials containing 1 mL of KRN23 at a concentration of 30mg/mL |
Timeline
- Start date
- 2021-11-01
- Primary completion
- 2023-12-18
- Completion
- 2023-12-18
- First posted
- 2021-04-12
- Last updated
- 2024-07-09
Locations
5 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04842032. Inclusion in this directory is not an endorsement.