<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/NCT03754634</url>
  </required_header>
  <id_info>
    <org_study_id>ITP-Diacerein</org_study_id>
    <nct_id>NCT03754634</nct_id>
  </id_info>
  <brief_title>A Prospective, Open, Multicenter Clinical Trial of Eltrombopag Combined With Diacerein in Eltrombopag-inefficient or Relapsed ITP</brief_title>
  <official_title>A Prospective, Open, Multicenter Clinical Trial of Eltrombopag Combined With Diacerein in the Management of Eltrombopag-inefficient or Relapsed ITP</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Affiliated Hospital of the Chinese Academy of Military Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Anhui Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital of Dalian Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shenzhen Second People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Zhejiang Provincial Hospital of TCM</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shandong University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Eltrombopag is an oral thrombopoietin receptor agonist that has been licensed for use as&#xD;
      second line therapy in ITP patients. Diacerein is a slow-acting medicine of the class&#xD;
      anthraquinone used to treat joint diseases such as osteoarthritis. The project was&#xD;
      undertaking by Qilu Hospital of Shandong University and other 5 well-known hospitals in&#xD;
      China. In order to report the efficacy and safety of eltrombopag combined with diacerein in&#xD;
      the management of ITP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators are undertaking a prospective, open, multicentre trial of 30 ITP adult&#xD;
      patients with eltrombopag-inefficient or relapsed from 6 medical centers in China. The&#xD;
      initial dose of eltrombopag administration is 25 mg orally once daily, which could be&#xD;
      transited to 50 mg/d in a 2-week cycle according to the need, and the maximum dose was not&#xD;
      more than 75 mg/d. The dose of diacerein administration is 50 mg orally twice daily. The&#xD;
      treatment was discontinued after 6 weeks without blood index reaction.&#xD;
&#xD;
      Platelet count, bleeding and other symptoms were evaluated before and after treatment.&#xD;
      Adverse events are also recorded throughout the study. In order to report the efficacy and&#xD;
      safety of eltrombopag combined with diacerein for the treatment of adults patients with&#xD;
      eltrombopag-inefficient or relapsed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2019</start_date>
  <completion_date type="Actual">November 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of platelet response</measure>
    <time_frame>the sixth weeks</time_frame>
    <description>R. A response (R) was defined as platelet count ≥ 30×10^9/L without bleeding</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Thrombocytopenia</condition>
  <arm_group>
    <arm_group_label>drugs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eltrombopag and Diacerein</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Eltrombopag and Diacerein</intervention_name>
    <description>The initial dose of eltrombopag administration is 25 mg orally once daily, which could be transited to 50 mg/d in a 2-week cycle according to the need, and the maximum dose was not more than 75 mg/d. The dose of diacerein administration is 50 mg orally twice daily. The treatment was discontinued after 6 weeks without blood index reaction.</description>
    <arm_group_label>drugs</arm_group_label>
    <other_name>diacetylrhein</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ITP patients with eltrombopag-inefficient or relapsed need of treatment(s) to minimize&#xD;
             the risk of clinically significant bleeding primary ITP confirmed by excluding other&#xD;
             supervened causes of thrombocytopenia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy hypertension cardiovascular disease diabetes liver and kidney function&#xD;
             impairment HCV, HIV, HBsAg seropositive status patients with systemic lupus&#xD;
             erythematosus and/or antiphospholipid syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Qilu hospital, Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Provan D, Stasi R, Newland AC, Blanchette VS, Bolton-Maggs P, Bussel JB, Chong BH, Cines DB, Gernsheimer TB, Godeau B, Grainger J, Greer I, Hunt BJ, Imbach PA, Lyons G, McMillan R, Rodeghiero F, Sanz MA, Tarantino M, Watson S, Young J, Kuter DJ. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010 Jan 14;115(2):168-86. doi: 10.1182/blood-2009-06-225565. Epub 2009 Oct 21.</citation>
    <PMID>19846889</PMID>
  </results_reference>
  <results_reference>
    <citation>Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kuhne T, Ruggeri M, George JN. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009 Mar 12;113(11):2386-93. doi: 10.1182/blood-2008-07-162503. Epub 2008 Nov 12.</citation>
    <PMID>19005182</PMID>
  </results_reference>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>November 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>September 10, 2023</last_update_submitted>
  <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shandong University</investigator_affiliation>
    <investigator_full_name>Ming Hou</investigator_full_name>
    <investigator_title>Professor and Director</investigator_title>
  </responsible_party>
  <keyword>ITP</keyword>
  <keyword>Eltrombopag</keyword>
  <keyword>Diacerein</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombocytopenia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diacerein</mesh_term>
  </intervention_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/NCT03754634
org study id: ITP-Diacerein
nct id: NCT03754634
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Eltrombopag is an oral thrombopoietin receptor agonist that has been licensed for use as
      second line therapy in ITP patients. Diacerein is a slow-acting medicine of the class
      anthraquinone used to treat joint diseases such as osteoarthritis. The project was
      undertaking by Qilu Hospital of Shandong University and other 5 well-known hospitals in
      China. In order to report the efficacy and safety of eltrombopag combined with diacerein in
      the management of ITP.
The investigators are undertaking a prospective, open, multicentre trial of 30 ITP adult
      patients with eltrombopag-inefficient or relapsed from 6 medical centers in China. The
      initial dose of eltrombopag administration is 25 mg orally once daily, which could be
      transited to 50 mg/d in a 2-week cycle according to the need, and the maximum dose was not
      more than 75 mg/d. The dose of diacerein administration is 50 mg orally twice daily. The
      treatment was discontinued after 6 weeks without blood index reaction.

      Platelet count, bleeding and other symptoms were evaluated before and after treatment.
      Adverse events are also recorded throughout the study. In order to report the efficacy and
      safety of eltrombopag combined with diacerein for the treatment of adults patients with
      eltrombopag-inefficient or relapsed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluation of platelet response
time frame: the sixth weeks
description: R. A response (R) was defined as platelet count ≥ 30×10^9/L without bleeding
arm group label: drugs
arm group type: Experimental
description: Eltrombopag and Diacerein
intervention type: Drug
intervention name: Eltrombopag and Diacerein
description: The initial dose of eltrombopag administration is 25 mg orally once daily, which could be transited to 50 mg/d in a 2-week cycle according to the need, and the maximum dose was not more than 75 mg/d. The dose of diacerein administration is 50 mg orally twice daily. The treatment was discontinued after 6 weeks without blood index reaction.
arm group label: drugs
other name: diacetylrhein
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: China
citation: Provan D, Stasi R, Newland AC, Blanchette VS, Bolton-Maggs P, Bussel JB, Chong BH, Cines DB, Gernsheimer TB, Godeau B, Grainger J, Greer I, Hunt BJ, Imbach PA, Lyons G, McMillan R, Rodeghiero F, Sanz MA, Tarantino M, Watson S, Young J, Kuter DJ. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010 Jan 14;115(2):168-86. doi: 10.1182/blood-2009-06-225565. Epub 2009 Oct 21.
PMID: 19846889
citation: Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kuhne T, Ruggeri M, George JN. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009 Mar 12;113(11):2386-93. doi: 10.1182/blood-2008-07-162503. Epub 2008 Nov 12.
PMID: 19005182
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Ming Hou
investigator title: Professor and Director
mesh term: Thrombocytopenia
mesh term: Diacerein