<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/NCT02217761</url>
  </required_header>
  <id_info>
    <org_study_id>201112163RID</org_study_id>
    <nct_id>NCT02217761</nct_id>
  </id_info>
  <brief_title>Pharmacokinetic Study in Patients Receiving Posaconazole Therapy in Taiwan</brief_title>
  <official_title>Pharmacokinetic Study in Patients Receiving Posaconazole Therapy in Taiwan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the factors influencing pharmacokinetic and&#xD;
      pharmacodynamic properties of new antifungal agent, posaconazole in Taiwanese patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Invasive fungal infection (IFI) may cause high mortality and morbidity in immune- compromised&#xD;
      patients. Posaconazole, a new triazole antifungal agent with broad spectrum coverage, was&#xD;
      approved for both treatment and prophylaxis of IFIs. Previous studies have demonstrated the&#xD;
      relationship between posaconazole plasma concentration and efficacy, thus, the importance of&#xD;
      posaconazole therapeutic drug monitoring (TDM) was gradually accepted. However, studies found&#xD;
      inter- and intra-individual variation between concentrations, and these phenomenons were&#xD;
      affected greatly by GI function, food intake and concomitant medication. Furthermore, there's&#xD;
      a lack of posaconazole TDM study in Asian population.&#xD;
&#xD;
      The study was designed to describe the prescribing pattern of posaconazole, to study the&#xD;
      relationship between concentration and clinical outcomes/ adverse events, to identify factors&#xD;
      that influence plasma concentration, and to evaluate whether routine TDM is needed in our&#xD;
      institution.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>March 2012</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Plasma posaconazole concentration</measure>
    <time_frame>7-10 days after taking posaconazole</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Pharmacokinetics</condition>
  <condition>Posaconazole</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood, serum. white cells, saliva&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients in National Taiwan University receiving posaconazole&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients receiving posaconazole therapy&#xD;
&#xD;
          -  Patients aged 13 years old or more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No posaconazole plasma concentration available&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shu-Wen Lin, Pharm. D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Graduate institute of clinical pharmacy at National Taiwan University</affiliation>
  </overall_official>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 13, 2014</last_update_submitted>
  <last_update_submitted_qc>August 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Antifungal Agents</keyword>
  <!-- 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/NCT02217761
org study id: 201112163RID
nct id: NCT02217761
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the factors influencing pharmacokinetic and
      pharmacodynamic properties of new antifungal agent, posaconazole in Taiwanese patients.
Invasive fungal infection (IFI) may cause high mortality and morbidity in immune- compromised
      patients. Posaconazole, a new triazole antifungal agent with broad spectrum coverage, was
      approved for both treatment and prophylaxis of IFIs. Previous studies have demonstrated the
      relationship between posaconazole plasma concentration and efficacy, thus, the importance of
      posaconazole therapeutic drug monitoring (TDM) was gradually accepted. However, studies found
      inter- and intra-individual variation between concentrations, and these phenomenons were
      affected greatly by GI function, food intake and concomitant medication. Furthermore, there's
      a lack of posaconazole TDM study in Asian population.

      The study was designed to describe the prescribing pattern of posaconazole, to study the
      relationship between concentration and clinical outcomes/ adverse events, to identify factors
      that influence plasma concentration, and to evaluate whether routine TDM is needed in our
      institution.
observational model: Case-Only
time perspective: Prospective
measure: Plasma posaconazole concentration
time frame: 7-10 days after taking posaconazole
Whole blood, serum. white cells, saliva
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 13 Years
maximum age: N/A
healthy volunteers: No
last name: Shu-Wen Lin, Pharm. D.
role: Principal Investigator
affiliation: Graduate institute of clinical pharmacy at National Taiwan University
responsible party type: Sponsor