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Individual Patient Compassionate Use of Burosumab

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ClinicalTrials.gov Identifier: NCT03775187
Expanded Access Status : Available
First Posted : December 13, 2018
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
Kyowa Kirin Co., Ltd.
Information provided by (Responsible Party):
Ultragenyx Pharmaceutical Inc

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

Condition or disease Intervention/treatment
X-linked Hypophosphatemia Tumor-Induced Osteomalacia Biological: Burosumab

Detailed Description:
Expanded access may provide access for treatment prior to approval by the local regulatory agency. For full details, please visit the link provided.

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Study Type : Expanded Access
Expanded Access Type : Individual Patients
  See clinical trials of the intervention/treatment in this expanded access record.



Intervention Details:
  • Biological: Burosumab
    Other Names:
    • UX023
    • Crysvita®
    • KRN23

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

-

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03775187


Contacts
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Contact: Early Access 1-415-483-8800 EarlyAccess@ultragenyx.com

Sponsors and Collaborators
Ultragenyx Pharmaceutical Inc
Kyowa Kirin Co., Ltd.

Additional Information:
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Responsible Party: Ultragenyx Pharmaceutical Inc
ClinicalTrials.gov Identifier: NCT03775187     History of Changes
Other Study ID Numbers: UX023-CU
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Keywords provided by Ultragenyx Pharmaceutical Inc:
Expanded Access
Compassionate Use
XLH
TIO
Additional relevant MeSH terms:
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Osteomalacia
Familial Hypophosphatemic Rickets
Hypophosphatemia
Phosphorus Metabolism Disorders
Metabolic Diseases
Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Calcium Metabolism Disorders
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Rickets, Hypophosphatemic
Hypophosphatemia, Familial
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Metal Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs