Back to resultsExpanded Access to Burosumab
Primary Purpose
X-linked Hypophosphatemia, Tumor-Induced Osteomalacia
Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Burosumab
Sponsored by
About this trial
This is an expanded access trial for X-linked Hypophosphatemia focused on measuring Expanded Access, Compassionate Use, XLH, TIO
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT03775187
First Posted
December 11, 2018
Last Updated
September 1, 2023
Sponsor
Ultragenyx Pharmaceutical Inc
Collaborators
Kyowa Kirin Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03775187
Brief Title
Expanded Access to Burosumab
Study Type
Expanded Access
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Available
Study Start Date
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Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ultragenyx Pharmaceutical Inc
Collaborators
Kyowa Kirin Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
Individual patient expanded access requests may be considered for patients who have no other treatment options
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
X-linked Hypophosphatemia, Tumor-Induced Osteomalacia
Keywords
Expanded Access, Compassionate Use, XLH, TIO
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Burosumab
Other Intervention Name(s)
UX023, Crysvita®, KRN23
10. Eligibility
Sex
All
Eligibility Criteria
Inclusion Criteria:
-
Exclusion Criteria:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Early Access
Phone
1-415-483-8800
Email
EarlyAccess@ultragenyx.com
12. IPD Sharing Statement
Links:
URL
https://www.ultragenyx.com/our-purpose/supporting-access-for-patients/?#investigational-therapies
Description
Access to Investigational Therapies / Requesting Access
URL
https://www.crysvita.com/
Description
Crysvita Patient and Prescribing Information Page
Learn more about this trial
Expanded Access to Burosumab
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