<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/NCT03032016</url>
  </required_header>
  <id_info>
    <org_study_id>DF VOD-2013-03-REG</org_study_id>
    <nct_id>NCT03032016</nct_id>
  </id_info>
  <brief_title>European VOD Registry</brief_title>
  <official_title>A Multi-centre, Multinational, Prospective Observational Registry to Collect Safety and Outcome Data in Patients Diagnosed With Severe Hepatic Veno-occlusive Disease (VOD) Following Hematopoietic Stem Cell Transplantation (HSCT) and Treated With Defitelio®</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jazz Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>European Society for Blood and Marrow Transplantation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Jazz Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Following the licencing of a new drug, Defitelio®, indicated for the treatment of severe&#xD;
      Veno-Occlusive Disease of the liver (sVOD), a rare but serious complication of haematopoietic&#xD;
      stem cell transplantation (HSCT), as a specific obligation (SOB), the manufacture and&#xD;
      marketing Authorisation Holder (MHA) (Gentium, a Jazz Pharmaceuticals Company) was required&#xD;
      by PRAC (Pharmacovigilance Risk Assessment Committee) to set up a disease registry to collect&#xD;
      safety and outcome data, and to assess patterns of utilization of Defitelio® in the&#xD;
      post-approval setting. This registry is a Post Authorization Safety Study (PASS), is being&#xD;
      coordinated in collaboration with the European Society for Blood and Marrow Transplantation&#xD;
      (EBMT). For this study, anonymised clinical data are being collected from patients who&#xD;
      develop VOD and and treated with and patients who have been treated with Defitelio® for&#xD;
      conditions other than sVOD.&#xD;
&#xD;
      The study DOES NOT involve decisions about treatment, which are clinical decisions, but&#xD;
      merely collection of data for patients who develop this complication, whether or not they&#xD;
      receive treatment and for patients who are treated with Defitelio® for any other reasons.The&#xD;
      study DOES NOT involve decisions about treatment, which are clinical decisions, but merely&#xD;
      collection of data for patients who develop this complication, whether or not they receive&#xD;
      treatment and for patients who are treated with Defitelio® for any other reasons.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Defitelio® was granted a Marketing Authorisation in Europe under exceptional circumstances on&#xD;
      18 October 2013. Defitelio® is indicated for the treatment of severe hepatic Veno-Occlusive&#xD;
      Disease (sVOD) also known as sinusoidal obstruction syndrome (SOS) in haematopoietic&#xD;
      stem-cell transplantation (HSCT) therapy.&#xD;
&#xD;
      It is indicated in adults and in adolescents, children and infants over 1 month of age.&#xD;
&#xD;
      As required by the risk management plan, Gentium set up a disease registry to collect safety&#xD;
      and outcome data, and to assess patterns of utilization of Defitelio® in the post-approval&#xD;
      setting.&#xD;
&#xD;
      This is a multi-centre, multinational and prospective observational (non-interventional)&#xD;
      disease registry of patients with severe hepatic VOD following HSCT and treated with&#xD;
      Defitelio®.&#xD;
&#xD;
      The registry will be conducted in European transplant centres that are members of the&#xD;
      European Society for Blood and Marrow Transplantation (EBMT).&#xD;
&#xD;
      The main objective of the registry is to assess the incidence rate of specific SAEs (Serious&#xD;
      Adverse Events) of interest (including fatalities) in patients with severe hepatic VOD&#xD;
      post-HSCT treated with Defitelio®.&#xD;
&#xD;
      Secondary objectives are:&#xD;
&#xD;
        -  To describe the population treated with Defibrotide (age, gender, patients with&#xD;
           pre-existing liver or severe renal insufficiency; patient with intrinsic lung disease)&#xD;
&#xD;
        -  To determine the incidence rate of multiorgan failure (MOF) and Graft versus host&#xD;
           disease (GvHD) in adult and paediatric patients receiving Defibrotide.&#xD;
&#xD;
        -  To determine survival by Day+100 post-HSCT, overall mortality and mortality due to VOD&#xD;
           in patients treated with Defibrotide.&#xD;
&#xD;
        -  To determine the rate of VOD and VOD with MOF resolution any time after treatment&#xD;
           initiation in patients treated with Defibrotide.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 24, 2015</start_date>
  <completion_date type="Actual">July 2019</completion_date>
  <primary_completion_date type="Actual">July 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence rate of specific SAE of interest</measure>
    <time_frame>over 12 months</time_frame>
    <description>Assess the incidence rate of specific SAEs of interest (including fatalities) in patients with severe hepatic VOD post-HSCT treated with Defitelio®</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Describe the population treated</measure>
    <time_frame>Enrolment</time_frame>
    <description>To describe the population treated with Defitelio® (age, gender, patients with pre-existing liver or severe renal insufficiency; patient with intrinsic lung disease)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GvHD incidence</measure>
    <time_frame>over 12 months</time_frame>
    <description>Determine the incidence rate of Graft versus host disease (GvHD) in adult and paediatric patients receiving Defitelio®</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>over 12 months</time_frame>
    <description>To determine survival by Day+100 post-HSCT, overall mortality and mortality due to VOD in patients treated with Defitelio®</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VOD/MOF Resolution</measure>
    <time_frame>over 12 months</time_frame>
    <description>To determine the rate of VOD and VOD with MOF resolution any time after treatment initiation in patients treated with Defitelio®</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">176</enrollment>
  <condition>Hepatic Veno-Occlusive Disease</condition>
  <arm_group>
    <arm_group_label>sVOD patient treated with defibrotide</arm_group_label>
    <description>Patient diagnosed with severe hepatic VOD and treated with defibrotide</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The patients will be selected by the treating physicians working in hospitals being part of&#xD;
        the European society for Bone Marrow Transplantation network.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing hematopoietic stem cell transplantation and diagnosed with severe&#xD;
             hepatic VOD, who agree to participate in the study (Main population).&#xD;
&#xD;
          -  Patients treated with defibrotide for another condition than severe hepatic VOD&#xD;
             (Secondary population) in the scope of hematopoietic stem cell transplantation .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  There will not be any specific exclusion criteria; however contraindications, special&#xD;
             warnings and precautions for use as detailed in the SPC will have to be considered by&#xD;
             the treating physician.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHRU Angers, Maladies du Sang</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Bordeaux Groupe hospitalier Pellegrin Enfants</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU d'Estaing</name>
      <address>
        <city>Clermont Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Lille</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Jeanne de Flandre</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU Limoges</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IHOP</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital d'enfants de la Timone</name>
      <address>
        <city>Mare aux Daims</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Paoli Calmette</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Lapeyronie</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nantes</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de l'ARCHET</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Saint Antoine</name>
      <address>
        <city>Paris</city>
        <zip>75012</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Robert Debré</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Tenon</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Haut Leveque</name>
      <address>
        <city>Pessac</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Miletrie</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Hautepierre</name>
      <address>
        <city>Strasbourg</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IUTC Oncopole</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy (Pediatrics)</name>
      <address>
        <city>Villejuif</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Papa Giovanni XXIII</name>
      <address>
        <city>Bergamo</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UO Oncoematologia Ospedale Pediatrico Mayer</name>
      <address>
        <city>Firenze</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale di Careggi</name>
      <address>
        <city>Florence</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute G. Gaslini</name>
      <address>
        <city>Genova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Ca' Granda Ospedale Maggiore di Milano</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale di Niguarda Ca' Granda</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Raffaele</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica di oncoematologia pediatrica</name>
      <address>
        <city>Padova</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Policlinico San Matteo</name>
      <address>
        <city>Pavia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Santa Maria de la Misericorda</name>
      <address>
        <city>Perugia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Carlo</name>
      <address>
        <city>Potenza</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRRCS Ospedale Pediatrico Bambino Gesù</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universita Cattolica S. Cuore</name>
      <address>
        <city>Roma</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>La Sapienza University Hospital</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU Citta della salute e delle Scienza</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Infantile Regina Margherita</name>
      <address>
        <city>Torino</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto per l'Infanzia IRCCS Burlo Garofolo</name>
      <address>
        <city>Trieste</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Ematologica-Azienda Ospedaliero Universitaria</name>
      <address>
        <city>Udine</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico G.B. Rossi, Clinica di Oncoematologia Pediatrica</name>
      <address>
        <city>Verona</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inst. Portugues Oncologia o Lisboa</name>
      <address>
        <city>Lisboa</city>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham Children's Hospital</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham Heartlands Hospital</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bristol Royal Hospital for Children</name>
      <address>
        <city>Bristol</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Ormond Street Hospital Children's Charity</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imperial College</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George's Hospital</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Manchester Children's Hospital</name>
      <address>
        <city>Manchester</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great North Children's Hospital</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham City Hospital</name>
      <address>
        <city>Nottingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Radccliffe Children's Hospital</name>
      <address>
        <city>Oxford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Plymouth Hospitals NHS Trust</name>
      <address>
        <city>Plymouth</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Italy</country>
    <country>Portugal</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Ireland</country>
  </removed_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 24, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>October 14, 2019</last_update_submitted>
  <last_update_submitted_qc>October 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>VOD</keyword>
  <keyword>Defibrotide</keyword>
  <keyword>Defitelio</keyword>
  <keyword>Registry</keyword>
  <keyword>SOS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatic Veno-Occlusive Disease</mesh_term>
  </condition_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/NCT03032016
org study id: DF VOD-2013-03-REG
nct id: NCT03032016
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated device: No
Following the licencing of a new drug, Defitelio®, indicated for the treatment of severe
      Veno-Occlusive Disease of the liver (sVOD), a rare but serious complication of haematopoietic
      stem cell transplantation (HSCT), as a specific obligation (SOB), the manufacture and
      marketing Authorisation Holder (MHA) (Gentium, a Jazz Pharmaceuticals Company) was required
      by PRAC (Pharmacovigilance Risk Assessment Committee) to set up a disease registry to collect
      safety and outcome data, and to assess patterns of utilization of Defitelio® in the
      post-approval setting. This registry is a Post Authorization Safety Study (PASS), is being
      coordinated in collaboration with the European Society for Blood and Marrow Transplantation
      (EBMT). For this study, anonymised clinical data are being collected from patients who
      develop VOD and and treated with and patients who have been treated with Defitelio® for
      conditions other than sVOD.

      The study DOES NOT involve decisions about treatment, which are clinical decisions, but
      merely collection of data for patients who develop this complication, whether or not they
      receive treatment and for patients who are treated with Defitelio® for any other reasons.The
      study DOES NOT involve decisions about treatment, which are clinical decisions, but merely
      collection of data for patients who develop this complication, whether or not they receive
      treatment and for patients who are treated with Defitelio® for any other reasons.
Defitelio® was granted a Marketing Authorisation in Europe under exceptional circumstances on
      18 October 2013. Defitelio® is indicated for the treatment of severe hepatic Veno-Occlusive
      Disease (sVOD) also known as sinusoidal obstruction syndrome (SOS) in haematopoietic
      stem-cell transplantation (HSCT) therapy.

      It is indicated in adults and in adolescents, children and infants over 1 month of age.

      As required by the risk management plan, Gentium set up a disease registry to collect safety
      and outcome data, and to assess patterns of utilization of Defitelio® in the post-approval
      setting.

      This is a multi-centre, multinational and prospective observational (non-interventional)
      disease registry of patients with severe hepatic VOD following HSCT and treated with
      Defitelio®.

      The registry will be conducted in European transplant centres that are members of the
      European Society for Blood and Marrow Transplantation (EBMT).

      The main objective of the registry is to assess the incidence rate of specific SAEs (Serious
      Adverse Events) of interest (including fatalities) in patients with severe hepatic VOD
      post-HSCT treated with Defitelio®.

      Secondary objectives are:

        -  To describe the population treated with Defibrotide (age, gender, patients with
           pre-existing liver or severe renal insufficiency; patient with intrinsic lung disease)

        -  To determine the incidence rate of multiorgan failure (MOF) and Graft versus host
           disease (GvHD) in adult and paediatric patients receiving Defibrotide.

        -  To determine survival by Day+100 post-HSCT, overall mortality and mortality due to VOD
           in patients treated with Defibrotide.

        -  To determine the rate of VOD and VOD with MOF resolution any time after treatment
           initiation in patients treated with Defibrotide.
observational model: Cohort
time perspective: Prospective
measure: Incidence rate of specific SAE of interest
time frame: over 12 months
description: Assess the incidence rate of specific SAEs of interest (including fatalities) in patients with severe hepatic VOD post-HSCT treated with Defitelio®
measure: Describe the population treated
time frame: Enrolment
description: To describe the population treated with Defitelio® (age, gender, patients with pre-existing liver or severe renal insufficiency; patient with intrinsic lung disease)
measure: GvHD incidence
time frame: over 12 months
description: Determine the incidence rate of Graft versus host disease (GvHD) in adult and paediatric patients receiving Defitelio®
measure: Survival
time frame: over 12 months
description: To determine survival by Day+100 post-HSCT, overall mortality and mortality due to VOD in patients treated with Defitelio®
measure: VOD/MOF Resolution
time frame: over 12 months
description: To determine the rate of VOD and VOD with MOF resolution any time after treatment initiation in patients treated with Defitelio®
arm group label: sVOD patient treated with defibrotide
description: Patient diagnosed with severe hepatic VOD and treated with defibrotide
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: N/A
healthy volunteers: No
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country: France
country: Italy
country: Portugal
country: United Kingdom
country: Ireland
responsible party type: Sponsor
mesh term: Hepatic Veno-Occlusive Disease
sharing ipd: No