<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03775187</url>
  </required_header>
  <id_info>
    <org_study_id>UX023-EAP</org_study_id>
    <nct_id>NCT03775187</nct_id>
  </id_info>
  <brief_title>Expanded Access to Burosumab</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ultragenyx Pharmaceutical Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kyowa Kirin Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Ultragenyx Pharmaceutical Inc</source>
  <brief_summary>
    <textblock>
      Individual patient expanded access requests may be considered for patients who have no other&#xD;
      treatment options&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Expanded access may be available outside of the US in countries prior to approval by the&#xD;
      local regulatory agencies. For full details, please visit the links provided below.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Available</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <expanded_access_info>
    <expanded_access_type_individual>Yes</expanded_access_type_individual>
  </expanded_access_info>
  <condition>X-linked Hypophosphatemia</condition>
  <condition>Tumor-Induced Osteomalacia</condition>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Burosumab</intervention_name>
    <other_name>UX023</other_name>
    <other_name>Crysvita®</other_name>
    <other_name>KRN23</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Early Access</last_name>
    <phone>1-415-483-8800</phone>
    <email>EarlyAccess@ultragenyx.com</email>
  </overall_contact>
  <link>
    <url>https://www.ultragenyx.com/our-purpose/supporting-access-for-patients/?#investigational-therapies</url>
    <description>Access to Investigational Therapies / Requesting Access</description>
  </link>
  <link>
    <url>https://www.crysvita.com/</url>
    <description>Crysvita Patient and Prescribing Information Page</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>September 1, 2023</last_update_submitted>
  <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Expanded Access</keyword>
  <keyword>Compassionate Use</keyword>
  <keyword>XLH</keyword>
  <keyword>TIO</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Familial Hypophosphatemic Rickets</mesh_term>
    <mesh_term>Osteomalacia</mesh_term>
    <mesh_term>Hypophosphatemia</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03775187
org study id: UX023-EAP
nct id: NCT03775187
lead sponsor: 
collaborator: 
Individual patient expanded access requests may be considered for patients who have no other
      treatment options
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.
expanded access type individual: Yes
intervention type: Biological
intervention name: Burosumab
other name: UX023
other name: Crysvita®
other name: KRN23
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Early Access
phone: 1-415-483-8800
email: EarlyAccess@ultragenyx.com
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
responsible party type: Sponsor
mesh term: Familial Hypophosphatemic Rickets
mesh term: Osteomalacia
mesh term: Hypophosphatemia