<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/NCT01733082</url>
  </required_header>
  <id_info>
    <org_study_id>ML22679</org_study_id>
    <nct_id>NCT01733082</nct_id>
  </id_info>
  <brief_title>The Mycophenolate Pregnancy Registry</brief_title>
  <official_title>The Mycophenolate Pregnancy Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Accord Healthcare, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sandoz</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Apotex Corporation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mylan Pharmaceuticals Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Teva Pharmaceuticals USA</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alkem Laboratories Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Roxane Laboratories</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vintage Pharmaceuticals, LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Genentech, Inc.</source>
  <brief_summary>
    <textblock>
      The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry&#xD;
      collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes,&#xD;
      fetal and infant outcomes after exposure. Early and later term pregnancy outcomes will be&#xD;
      solicited at selected gestational time points. Structural and functional birth defects&#xD;
      identified in the perinatal period through one year of life will be collected and classified.&#xD;
&#xD;
      This is a non-proprietary registry and is a component of a comprehensive pregnancy Risk&#xD;
      Evaluation and Mitigation Strategy (REMS) plan required by the FDA for all&#xD;
      mycophenolate-formulations, including CellCept, Myfortic and any generic formulations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 30, 2012</start_date>
  <completion_date type="Anticipated">May 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 30, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Maternal outcomes: Incidence of pregnancy complications</measure>
    <time_frame>approximately 8 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Fetal outcomes: Incidence of congenital disorders</measure>
    <time_frame>approximately 8 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time/duration of mycophenolate exposure</measure>
    <time_frame>approximately 8 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mycophenolate dose/regimen</measure>
    <time_frame>approximately 8 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Indications for mycophenolate use</measure>
    <time_frame>approximately 8 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal medical/demographic characteristics</measure>
    <time_frame>approximately 8 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of educational counseling on the risks of birth defects with mycophenolate therapy</measure>
    <time_frame>approximately 8 years</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Heart Transplantation, Kidney Transplantation, Liver Transplantation, Autoimmune Diseases</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnancy and reported exposure to mycophenolate during pregnancy or within 6 weeks of&#xD;
        discontinuing treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnancy and reported maternal exposure to mycophenolate during pregnancy or within 6&#xD;
             weeks of discontinuing treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancies for which there is paternal exposure only&#xD;
&#xD;
          -  Pregnancies occurring outside the U.S.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Genentech, Inc.</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Reference Study ID Number: ML22679 https://forpatients.roche.com/</last_name>
    <phone>888-662-6728 (U.S. and Canada)</phone>
    <email>global.rochegenentechtrials@roche.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Quintiles Outcome</name>
      <address>
        <city>Cambridge</city>
        <state>Massachusetts</state>
        <zip>02139</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autoimmune Diseases</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/NCT01733082
org study id: ML22679
nct id: NCT01733082
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
The Mycophenolate Pregnancy Registry is designed as a prospective, observational registry
      collecting data regarding mycophenolate exposure during pregnancy, and pregnancy outcomes,
      fetal and infant outcomes after exposure. Early and later term pregnancy outcomes will be
      solicited at selected gestational time points. Structural and functional birth defects
      identified in the perinatal period through one year of life will be collected and classified.

      This is a non-proprietary registry and is a component of a comprehensive pregnancy Risk
      Evaluation and Mitigation Strategy (REMS) plan required by the FDA for all
      mycophenolate-formulations, including CellCept, Myfortic and any generic formulations.
observational model: Cohort
time perspective: Prospective
measure: Maternal outcomes: Incidence of pregnancy complications
time frame: approximately 8 years
measure: Fetal outcomes: Incidence of congenital disorders
time frame: approximately 8 years
measure: Time/duration of mycophenolate exposure
time frame: approximately 8 years
measure: Mycophenolate dose/regimen
time frame: approximately 8 years
measure: Indications for mycophenolate use
time frame: approximately 8 years
measure: Maternal medical/demographic characteristics
time frame: approximately 8 years
measure: Occurrence of educational counseling on the risks of birth defects with mycophenolate therapy
time frame: approximately 8 years
arm group label: Cohort
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Genentech, Inc.
last name: Reference Study ID Number: ML22679 https://forpatients.roche.com/
phone: 888-662-6728 (U.S. and Canada)
email: global.rochegenentechtrials@roche.com
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Autoimmune Diseases