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Study of the Anti-FGF23 Antibody, Burosumab, in Adults With XLH

NCT03920072 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-05-20

No results posted yet for this study

Summary

This is phase 3b open-label, international, multicenter study to continue to monitor the long-term safety and efficacy of burosumab in adult patients with XLH that participated in previous clinical trials with burosumab (UX023-CL303 / UX023-CL304).

Conditions

  • X-linked Hypophosphatemia

Interventions

DRUG

Burosumab

Burosumab is a sterile, clear, colourless and preservative free solution supplied in single-use 5ml vials containing 1mL of burosumab at a concentration of 30mg/mL

Sponsors & Collaborators

  • Kyowa Kirin Pharmaceutical Development Ltd

    lead INDUSTRY

Principal Investigators

  • Peter Kamenicky · CHU de Bicêtre

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-03-07
Primary Completion
2022-04-07
Completion
2022-04-07
FDA Drug
Yes

Countries

  • France
  • Ireland
  • Italy
  • United Kingdom

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 NCT03920072 on ClinicalTrials.gov