<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/NCT01660334</url>
  </required_header>
  <id_info>
    <org_study_id>A1501077</org_study_id>
    <nct_id>NCT01660334</nct_id>
  </id_info>
  <brief_title>Voriconazole (Vfend) Special Investigation (Regulatory Post Marketing Commitment Plan)</brief_title>
  <official_title>Special Investigation of Vfend on Scedosporisis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To collect the efficacy and safety information of voriconazole related to their appropriate&#xD;
      use in daily practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2006</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Serious Treatment Related Adverse Events.</measure>
    <time_frame>16 weeks</time_frame>
    <description>Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Serious adverse events were defined as those including death, fatal risk, hospitalization or prolongation of hospitalization period, continuous dysfunction, those causing malformation, and serious ones like the above-cited events. Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Response of Cure at the Test-of-Cure(TOC) Visit.</measure>
    <time_frame>16 weeks</time_frame>
    <description>The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the participants for efficacy analysis.&#xD;
Clinical response of cure was assessed comprehensively by physicians in the three categories, which were &quot;effective&quot;, &quot;ineffective&quot;, and &quot;not evaluable&quot;, based on the clinical symptoms, imaging diagnosis and endoscopy, fungal tests, and serological tests.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">13</enrollment>
  <condition>Scedosporium Infection</condition>
  <arm_group>
    <arm_group_label>Voriconazole</arm_group_label>
    <description>Subjects who are treated with voriconazole</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Voriconazole</intervention_name>
    <description>Voriconazole Intravenous Solution 200 mg:&#xD;
Voriconazole is administered by intravenous drip infusion at the dose of 6 mg/kg twice daily on day 1 and 3 mg/kg or 4 mg/kg twice daily from day 2 onward in adults.&#xD;
Voriconazole Tablet 50 mg/ Voriconazole Tablet 200 mg:&#xD;
administration for an adult (weighing 40 kg or more) is voriconazole 300mg orally twice daily between meals for day 1 and then 150 mg or 200 mg twice daily between meals from day 2 onward.&#xD;
Depending on the symptoms or in cases where the effect is insufficient, the dosage may be increased.&#xD;
However, the maximum dose on day 1 must be 400 mg twice daily, and the maximum dose from day 2 onward must be 300 mg twice daily.&#xD;
In patients weighing less than 40 kg, voriconazole 150 mg shall be administered twice daily on day 1, and voriconazole 100 mg shall be administered twice daily from day 2 onward.&#xD;
Depending on the symptoms, the maintenance dose from day 2 onward may be increased to 150 mg twice daily.</description>
    <arm_group_label>Voriconazole</arm_group_label>
    <other_name>VFEND for Intravenous Use, Voriconazole for Intravenous Use, VFEND Tablets, Voriconazole Tablet</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients whom an investigator involving A1501077 prescribes the voriconazole (VFEND).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Male or Female patients who are prescribed voriconazole (VFEND) for deep mycosis on&#xD;
        Scedosporisis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subject who have been prescribed voriconazole (VFEND) for deep mycosis on Aspergillus,&#xD;
        Candidasis,Cryptococcal infections not involving Scedosporisis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1501077&amp;StudyName=Voriconazole%20%28Vfend%29%20Special%20Investigation%20%28Regulatory%20Post%20Marketing%20Commitment%20Plan%29%20%20%0A%0A</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>October 2013</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>August 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2012</study_first_posted>
  <results_first_submitted>May 14, 2013</results_first_submitted>
  <results_first_submitted_qc>October 30, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 17, 2013</results_first_posted>
  <last_update_submitted>October 30, 2013</last_update_submitted>
  <last_update_submitted_qc>October 30, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 17, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Systemic Mycosis</keyword>
  <keyword>Scedosporium infection</keyword>
  <keyword>Scedosporisis</keyword>
  <keyword>Japanese</keyword>
  <keyword>voriconazole</keyword>
  <keyword>VFEND</keyword>
  <keyword>Regulatory Post Marketing Commitment Plan.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Voriconazole</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Voriconazole for Scedosporium Disease</title>
          <description>Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Voriconazole for Scedosporium Disease</title>
          <description>Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt;65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;=65 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Serious Treatment Related Adverse Events.</title>
        <description>Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Serious adverse events were defined as those including death, fatal risk, hospitalization or prolongation of hospitalization period, continuous dysfunction, those causing malformation, and serious ones like the above-cited events. Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.</description>
        <time_frame>16 weeks</time_frame>
        <population>The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.</population>
        <group_list>
          <group group_id="O1">
            <title>Voriconazole for Scedosporium Disease</title>
            <description>Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Treatment Related Adverse Events.</title>
          <description>Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Serious adverse events were defined as those including death, fatal risk, hospitalization or prolongation of hospitalization period, continuous dysfunction, those causing malformation, and serious ones like the above-cited events. Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.</description>
          <population>The safety analysis population consists of the participants who satisfy the case conditions and in whom administration of this drug was confirmed.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Response of Cure at the Test-of-Cure(TOC) Visit.</title>
        <description>The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the participants for efficacy analysis.&#xD;
Clinical response of cure was assessed comprehensively by physicians in the three categories, which were &quot;effective&quot;, &quot;ineffective&quot;, and &quot;not evaluable&quot;, based on the clinical symptoms, imaging diagnosis and endoscopy, fungal tests, and serological tests.</description>
        <time_frame>16 weeks</time_frame>
        <population>The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).</population>
        <group_list>
          <group group_id="O1">
            <title>Voriconazole for Scedosporium Disease</title>
            <description>Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Response of Cure at the Test-of-Cure(TOC) Visit.</title>
          <description>The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the participants for efficacy analysis.&#xD;
Clinical response of cure was assessed comprehensively by physicians in the three categories, which were &quot;effective&quot;, &quot;ineffective&quot;, and &quot;not evaluable&quot;, based on the clinical symptoms, imaging diagnosis and endoscopy, fungal tests, and serological tests.</description>
          <population>The efficacy analysis population basically consists of the evaluable cases in accordance with the separately prepared analysis plan (cases judged to have been evaluated appropriately).</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>The frequency of treatment related adverse events during the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Voriconazole for Scedosporium Disease</title>
          <description>Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA-J 14.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Hallucination, visual</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA-J 14.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatic function abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Liver disorder</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Blood alkaline phosphatase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer, Inc.</organization>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01660334
org study id: A1501077
nct id: NCT01660334
lead sponsor: 
has dmc: No
To collect the efficacy and safety information of voriconazole related to their appropriate
      use in daily practice.
observational model: Case-Only
time perspective: Retrospective
measure: Number of Participants With Serious Treatment Related Adverse Events.
time frame: 16 weeks
description: Adverse events mean all unfavorable events that occur in participants after administration of Voriconazole, irrespective of causal relationship to Voriconazole (including clinically problematic abnormal changes in laboratory test values). Serious adverse events were defined as those including death, fatal risk, hospitalization or prolongation of hospitalization period, continuous dysfunction, those causing malformation, and serious ones like the above-cited events. Treatment related Adverse Events were evaluated in company with the causal relationship to Voriconazole.
measure: Number of Participants With Clinical Response of Cure at the Test-of-Cure(TOC) Visit.
time frame: 16 weeks
description: The primary endpoint was the efficacy ratio (number of effective cases/number of evaluable cases for efficacy assessment) among the cohort comprising the participants for efficacy analysis.
Clinical response of cure was assessed comprehensively by physicians in the three categories, which were "effective", "ineffective", and "not evaluable", based on the clinical symptoms, imaging diagnosis and endoscopy, fungal tests, and serological tests.
arm group label: Voriconazole
description: Subjects who are treated with voriconazole
intervention type: Drug
intervention name: Voriconazole
description: Voriconazole Intravenous Solution 200 mg:
Voriconazole is administered by intravenous drip infusion at the dose of 6 mg/kg twice daily on day 1 and 3 mg/kg or 4 mg/kg twice daily from day 2 onward in adults.
Voriconazole Tablet 50 mg/ Voriconazole Tablet 200 mg:
administration for an adult (weighing 40 kg or more) is voriconazole 300mg orally twice daily between meals for day 1 and then 150 mg or 200 mg twice daily between meals from day 2 onward.
Depending on the symptoms or in cases where the effect is insufficient, the dosage may be increased.
However, the maximum dose on day 1 must be 400 mg twice daily, and the maximum dose from day 2 onward must be 300 mg twice daily.
In patients weighing less than 40 kg, voriconazole 150 mg shall be administered twice daily on day 1, and voriconazole 100 mg shall be administered twice daily from day 2 onward.
Depending on the symptoms, the maintenance dose from day 2 onward may be increased to 150 mg twice daily.
arm group label: Voriconazole
other name: VFEND for Intravenous Use, Voriconazole for Intravenous Use, VFEND Tablets, Voriconazole Tablet
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1501077&StudyName=Voriconazole%20%28Vfend%29%20Special%20Investigation%20%28Regulatory%20Post%20Marketing%20Commitment%20Plan%29%20%20%0A%0A
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Infections
mesh term: Voriconazole
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 