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NCT03775187 Clinical Trial

Expanded Access to Burosumab

X-linked Hypophosphatemia Clinical Trial

Clinical Trial Details — Status: Available

Administrative data
NCT number NCT03775187
Other study ID # UX023-EAP
Secondary ID
Status Available
Phase
First received
Last updated

Study information
Verified date June 2024
Source Ultragenyx Pharmaceutical Inc
Contact Early Access
Phone 1-415-483-8800
Email EarlyAccess@ultragenyx.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

Individual patient expanded access requests may be considered for patients who have no other treatment options

Description:

Expanded access may be available outside of the US in countries prior to approval by the local regulatory agencies. For full details, please visit the links provided below.

Recruitment information / eligibility
Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Burosumab

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Ultragenyx Pharmaceutical Inc Kyowa Kirin Co., Ltd.
See also
  Status Clinical Trial Phase
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Recruiting NCT03879915 - Dental Implants in Patients With X-linked Hypophosphatemia
Active, not recruiting NCT03193476 - Registry for Patients With X-Linked Hypophosphatemia
Completed NCT02526160 - Study of KRN23 in Adults With X-linked Hypophosphatemia (XLH) Phase 3
Completed NCT05181839 - A Study to Describe the Lived Experience of XLH for Adolescents at End of Skeletal Growth
Completed NCT04146935 - Examining the Effect of Burosumab on Muscle Function Phase 4
Completed NCT02750618 - Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH) Phase 2
Active, not recruiting NCT03745521 - Study of Longitudinal Observation for Patient With X-linked Hypophosphatemic Rickets/Osteomalacia in Collaboration With Asian Partners
Completed NCT03920072 - Study of the Anti-FGF23 Antibody, Burosumab, in Adults With XLH Phase 3
Recruiting NCT03748966 - Calcitriol Monotherapy for X-Linked Hypophosphatemia Early Phase 1
Recruiting NCT04419363 - Burosumab in Children and Adolescents With X-linked Hypophosphatemia Phase 4
Completed NCT02163577 - Study of KRN23 (Burosumab), a Recombinant Fully Human Monoclonal Antibody Against Fibroblast Growth Factor 23 (FGF23), in Pediatric Subjects With X-linked Hypophosphatemia (XLH) Phase 2
Active, not recruiting NCT03651505 - X-linked Hypophosphatemia Disease Monitoring Program
Completed NCT06067932 - Foot Disorders in X-linked Hypophosphatemia
Completed NCT04695860 - Anti-FGF23 (Burosumab) in Adult Patients With XLH Phase 3
Completed NCT02312687 - Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH) Phase 2
Completed NCT03596554 - X-linked Hypophosphatemia and FGF21
Recruiting NCT03820518 - Using Different Doses of Active Vitamin D Combined With Neutral Phosphate in Children With X-linked Hypophosphatemia Phase 4
Completed NCT01571596 - An Extension Study of KRN23 in Adults With X-Linked Hypophosphatemia Phase 1/Phase 2
Completed NCT04273490 - Characterising Pain, QoL, Body Composition, Arterial Stiffness, Muscles and Bones in Adult Persons With XLH and Healthy Controls

External Links