<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/NCT03833297</url>
  </required_header>
  <id_info>
    <org_study_id>CIC1421-19-02</org_study_id>
    <nct_id>NCT03833297</nct_id>
  </id_info>
  <brief_title>Monitoring the HePAtological TOXicity of Drugs (HePATOX)</brief_title>
  <acronym>HePATOX</acronym>
  <official_title>Monitoring the HePAtological TOXicity of Drugs</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe Hospitalier Pitie-Salpetriere</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Groupe Hospitalier Pitie-Salpetriere</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Several drugs and chemotherapies seem to have an impact on the hepatological system. This&#xD;
      study investigates reports of hepatological toxicities, including the International&#xD;
      classification of disease ICD-10 for treatments in the World Health Organization (WHO) global&#xD;
      Individual Case Safety Report (ICSR) database (VigiBase).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several drugs and chemotherapies seem to have an impact on the hepatological system and are&#xD;
      responsible of a wide range of hepatological diseases and side effects. Those are poorly&#xD;
      described, due to the modification of the pharmacopeia, and the recent recognition of several&#xD;
      of these adverse events. This study investigates the main characteristics of patients&#xD;
      affected by rare hepatological side effects imputed to drugs. A causality assessment&#xD;
      according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is&#xD;
      systematically applied.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Actual">April 4, 2023</completion_date>
  <primary_completion_date type="Actual">February 4, 2020</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hepatological toxicities of drugs Identification and report of cases of hepatological toxicities associated with drugs.</measure>
    <time_frame>Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Causality assessment of reported hepatological toxicities events according to the WHO system</measure>
    <time_frame>Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the type of hepatoilogical toxicity depending on the category of drug</measure>
    <time_frame>Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the other immune related adverse events concomitant to the hepatological toxicity induced by drugs</measure>
    <time_frame>Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the duration of treatment when the toxicity happens (role of cumulative dose)</measure>
    <time_frame>Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the drug-drug interactions associated with adverse events</measure>
    <time_frame>Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the pathologies (cancer) for which the incriminated drugs have been prescribed</measure>
    <time_frame>Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of the population of patients having hepatological toxicity adverse event</measure>
    <time_frame>Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1000</enrollment>
  <condition>Liver Diseases</condition>
  <condition>Liver Dysfunction</condition>
  <condition>Liver Failure</condition>
  <condition>Hepatotoxicity</condition>
  <arm_group>
    <arm_group_label>Hepatological toxicity induced by drugs and chemotherapies</arm_group_label>
    <description>Case reported in the World Health Organization (WHO) of hepatological toxicities of patient treated by a drug, with a chronology compatible with the drug toxicity</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Drugs inducing hepatological toxicity</intervention_name>
    <description>Drugs susceptible to induce hepatological toxicities</description>
    <arm_group_label>Hepatological toxicity induced by drugs and chemotherapies</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients treated with a drug that could be reported in the WHO's pharmacovigilance database&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Case reported in the WHO's pharmacovigilance database till 04/02/2019&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronology not compatible between the drug and the toxicity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>AP-HP, Pitié-Salpêtrière Hospital, Department of Pharmacology, CIC-1421, Pharmacovigilance Unit, INSERM</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>April 4, 2023</last_update_submitted>
  <last_update_submitted_qc>April 4, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Groupe Hospitalier Pitie-Salpetriere</investigator_affiliation>
    <investigator_full_name>Joe Elie Salem</investigator_full_name>
    <investigator_title>Assistant director, clinical investigation center Paris Est</investigator_title>
  </responsible_party>
  <keyword>hepatological disease</keyword>
  <keyword>hepatotoxicity</keyword>
  <keyword>chemotherapies</keyword>
  <keyword>drugs</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Liver Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03833297
org study id: CIC1421-19-02
nct id: NCT03833297
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Several drugs and chemotherapies seem to have an impact on the hepatological system. This
      study investigates reports of hepatological toxicities, including the International
      classification of disease ICD-10 for treatments in the World Health Organization (WHO) global
      Individual Case Safety Report (ICSR) database (VigiBase).
Several drugs and chemotherapies seem to have an impact on the hepatological system and are
      responsible of a wide range of hepatological diseases and side effects. Those are poorly
      described, due to the modification of the pharmacopeia, and the recent recognition of several
      of these adverse events. This study investigates the main characteristics of patients
      affected by rare hepatological side effects imputed to drugs. A causality assessment
      according to the WHO-UMC (World Health Organization - Uppsala Monitoring Center) is
      systematically applied.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Hepatological toxicities of drugs Identification and report of cases of hepatological toxicities associated with drugs.
time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
measure: Causality assessment of reported hepatological toxicities events according to the WHO system
time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
measure: Description of the type of hepatoilogical toxicity depending on the category of drug
time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
measure: Description of the other immune related adverse events concomitant to the hepatological toxicity induced by drugs
time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
measure: Description of the duration of treatment when the toxicity happens (role of cumulative dose)
time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
measure: Description of the drug-drug interactions associated with adverse events
time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
measure: Description of the pathologies (cancer) for which the incriminated drugs have been prescribed
time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
measure: Description of the population of patients having hepatological toxicity adverse event
time frame: Case reported in the World Health Organization (WHO) database of individual safety case reports to 04/02/2019
arm group label: Hepatological toxicity induced by drugs and chemotherapies
description: Case reported in the World Health Organization (WHO) of hepatological toxicities of patient treated by a drug, with a chronology compatible with the drug toxicity
intervention type: Drug
intervention name: Drugs inducing hepatological toxicity
description: Drugs susceptible to induce hepatological toxicities
arm group label: Hepatological toxicity induced by drugs and chemotherapies
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Groupe Hospitalier Pitie-Salpetriere
investigator full name: Joe Elie Salem
investigator title: Assistant director, clinical investigation center Paris Est
mesh term: Liver Diseases
mesh term: Liver Failure
sharing ipd: Undecided