<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/NCT03299829</url>
  </required_header>
  <id_info>
    <org_study_id>EB-TR-001</org_study_id>
    <nct_id>NCT03299829</nct_id>
  </id_info>
  <brief_title>A Retrospective Study to Assess the Clinical Efficacy and Safety of Trientine in Wilson's Disease Patients</brief_title>
  <official_title>A Retrospective Study to Assess the Clinical Efficacy and Safety of Trientine in Wilson's Disease Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Excelsior</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Excelsior</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a retrospective study to assess the clinical efficacy and safety of trientine in&#xD;
      Wilson's disease patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this retrospective study, the investigators will collect and analyze data from reviewing&#xD;
      medical history files of larger and long-term follow-up cohorts with Wilson's disease in&#xD;
      Taiwan to assess the efficacy and safety of Trientine in Taiwanese Wilson's Disease patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 10, 2018</start_date>
  <completion_date type="Actual">December 30, 2019</completion_date>
  <primary_completion_date type="Actual">June 30, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The improvement in liver function</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>To measure the AST (aspartate aminotransferase), ALT (alanine transaminase), GGT (gamma-glutamyl transpeptidase), Albumin, and Bilirubin level, and compare to the baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The improvement in urine copper excretion</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>To measure 24-hour urine copper levels during the study period</description>
  </secondary_outcome>
  <enrollment type="Actual">48</enrollment>
  <condition>Trientine Treatment for Wilson's Disease</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Trientine</intervention_name>
    <description>Trientine is a chelating agent for removing the copper from the body</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who had the diagnosis of Wilson's disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Wilson's disease.&#xD;
&#xD;
          -  Male or female patients, aged 3 years to 75 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with comorbidity which is not related to Wilson's disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chinchang Huange, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital, Linkou</name>
      <address>
        <city>Taoyuan City</city>
        <zip>333</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>August 17, 2020</last_update_submitted>
  <last_update_submitted_qc>August 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>trientine</keyword>
  <keyword>Wilson's disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatolenticular Degeneration</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trientine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03299829
org study id: EB-TR-001
nct id: NCT03299829
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a retrospective study to assess the clinical efficacy and safety of trientine in
      Wilson's disease patients
In this retrospective study, the investigators will collect and analyze data from reviewing
      medical history files of larger and long-term follow-up cohorts with Wilson's disease in
      Taiwan to assess the efficacy and safety of Trientine in Taiwanese Wilson's Disease patients.
observational model: Cohort
time perspective: Retrospective
measure: The improvement in liver function
time frame: Up to 1 year
description: To measure the AST (aspartate aminotransferase), ALT (alanine transaminase), GGT (gamma-glutamyl transpeptidase), Albumin, and Bilirubin level, and compare to the baseline
measure: The improvement in urine copper excretion
time frame: Up to 1 year
description: To measure 24-hour urine copper levels during the study period
intervention type: Drug
intervention name: Trientine
description: Trientine is a chelating agent for removing the copper from the body
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 75 Years
healthy volunteers: No
last name: Chinchang Huange, Doctor
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Hepatolenticular Degeneration
mesh term: Trientine
sharing ipd: No