<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/NCT03820960</url>
  </required_header>
  <id_info>
    <org_study_id>RC31/17/0148</org_study_id>
    <nct_id>NCT03820960</nct_id>
  </id_info>
  <brief_title>Risk Factors for Thrombosis in Immune Thrombocytopenia</brief_title>
  <acronym>RiFT-ITP</acronym>
  <official_title>Risk Factors for Thrombosis in Immune Thrombocytopenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Toulouse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Toulouse</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>
      Immune thrombocytopenia (ITP) is a rare autoimmune disease (annual incidence: 3-4/105&#xD;
      inhabitants) leading to an increased risk of spontaneous bleeding. ITP is said &quot;primary&quot; when&#xD;
      not associated to other systemic disease (lymphoma, systemic autoimmune disease, chronic&#xD;
      infectious disease…). First-line treatment is based on corticosteroids. Intravenous&#xD;
      immunoglobulin (IVIg) is added in case of serious bleeding. In about 70% of adult cases, ITP&#xD;
      becomes persistent or chronic (lasting &gt;3 months and &gt;12 months, respectively). Second-line&#xD;
      treatments are then indicated. Among them, thrombopoietin-receptor agonists (TPO-RAs),&#xD;
      romiplostim and eltrombopag are increasingly used. Splenectomy is used as ultimate treatment.&#xD;
&#xD;
      Paradoxically, the risk of thrombosis is higher in ITP patients in comparison with the&#xD;
      general population, due to the release of young hyperactive platelets from bone marrow. The&#xD;
      incidence of thrombosis in ITP patients has been estimated between 0.5 and 3/100&#xD;
      patients-years. However, risk factors for thrombosis in ITP are not known, except splenectomy&#xD;
      that is used in very few patients now. The role of other ITP treatments in thrombosis&#xD;
      occurrence has been evoked, particularly for corticosteroids and IVIg. TPO-RAs have been&#xD;
      associated with a risk of thrombosis in clinical trials and pharmacovigilance studies, even&#xD;
      in case of low or normal platelet count. However, this risk has not been measured in the&#xD;
      real-life practice, adjusted for other risk factors for thrombosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Risk for thrombosis in adult primary ITP patients treated with ITP treatment</measure>
    <time_frame>from July 2009 until June 2015</time_frame>
    <description>Number of first hospitalization for arterial and veinous thrombosis in patients treated with ITP treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk thrombosis in adult primary ITP patients treated with TPO-RAs.</measure>
    <time_frame>from July 2009 until June 2015</time_frame>
    <description>Number of first hospitalization for arterial and veinous thrombosis in patients treated with ITP patients treated with TPO-RAs.</description>
  </secondary_outcome>
  <enrollment type="Actual">10039</enrollment>
  <condition>Immune Thrombocytopenia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Observational population-based study in France in the French Adult Immune THrombocytopenia&#xD;
        (FAITH) cohort from July 2009 until June 2015. The FAITH study identifies since July 2009&#xD;
        all incident primary ITP adults in France within the national health insurance database&#xD;
        (Système National d'Informations Inter-Régimes de l'Assurance Maladie, SNIIRAM, &gt;66 million&#xD;
        inhabitants).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Incident primary ITP adults&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary as well as prevalent ITP patients on July, 30th 2009 are excluded by the&#xD;
             algorithm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guillaume Moulis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Toulouse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Toulouse</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <results_reference>
    <citation>Lafaurie M, Maquet J, Baricault B, Ekstrand C, Christiansen CF, Linder M, Bahmanyar S, Norgaard M, Sailler L, Lapeyre-Mestre M, Sommet A, Moulis G. Risk factors of hospitalisation for thrombosis in adults with primary immune thrombocytopenia, including disease-specific treatments: a French nationwide cohort study. Br J Haematol. 2021 Nov;195(3):456-465. doi: 10.1111/bjh.17709. Epub 2021 Aug 12.</citation>
    <PMID>34386974</PMID>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>September 3, 2021</last_update_submitted>
  <last_update_submitted_qc>September 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Thrombosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Thrombocytopenia</mesh_term>
    <mesh_term>Purpura, Thrombocytopenic, Idiopathic</mesh_term>
  </condition_browse>
  <!-- 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/NCT03820960
org study id: RC31/17/0148
nct id: NCT03820960
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Immune thrombocytopenia (ITP) is a rare autoimmune disease (annual incidence: 3-4/105
      inhabitants) leading to an increased risk of spontaneous bleeding. ITP is said "primary" when
      not associated to other systemic disease (lymphoma, systemic autoimmune disease, chronic
      infectious disease…). First-line treatment is based on corticosteroids. Intravenous
      immunoglobulin (IVIg) is added in case of serious bleeding. In about 70% of adult cases, ITP
      becomes persistent or chronic (lasting >3 months and >12 months, respectively). Second-line
      treatments are then indicated. Among them, thrombopoietin-receptor agonists (TPO-RAs),
      romiplostim and eltrombopag are increasingly used. Splenectomy is used as ultimate treatment.

      Paradoxically, the risk of thrombosis is higher in ITP patients in comparison with the
      general population, due to the release of young hyperactive platelets from bone marrow. The
      incidence of thrombosis in ITP patients has been estimated between 0.5 and 3/100
      patients-years. However, risk factors for thrombosis in ITP are not known, except splenectomy
      that is used in very few patients now. The role of other ITP treatments in thrombosis
      occurrence has been evoked, particularly for corticosteroids and IVIg. TPO-RAs have been
      associated with a risk of thrombosis in clinical trials and pharmacovigilance studies, even
      in case of low or normal platelet count. However, this risk has not been measured in the
      real-life practice, adjusted for other risk factors for thrombosis.
observational model: Case-Control
time perspective: Retrospective
measure: Risk for thrombosis in adult primary ITP patients treated with ITP treatment
time frame: from July 2009 until June 2015
description: Number of first hospitalization for arterial and veinous thrombosis in patients treated with ITP treatment
measure: Risk thrombosis in adult primary ITP patients treated with TPO-RAs.
time frame: from July 2009 until June 2015
description: Number of first hospitalization for arterial and veinous thrombosis in patients treated with ITP patients treated with TPO-RAs.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guillaume Moulis, MD
role: Principal Investigator
affiliation: University Hospital, Toulouse
facility: 
country: France
citation: Lafaurie M, Maquet J, Baricault B, Ekstrand C, Christiansen CF, Linder M, Bahmanyar S, Norgaard M, Sailler L, Lapeyre-Mestre M, Sommet A, Moulis G. Risk factors of hospitalisation for thrombosis in adults with primary immune thrombocytopenia, including disease-specific treatments: a French nationwide cohort study. Br J Haematol. 2021 Nov;195(3):456-465. doi: 10.1111/bjh.17709. Epub 2021 Aug 12.
PMID: 34386974
responsible party type: Sponsor
mesh term: Thrombosis
mesh term: Thrombocytopenia
mesh term: Purpura, Thrombocytopenic, Idiopathic