<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/NCT01734044</url>
  </required_header>
  <id_info>
    <org_study_id>ITP-007</org_study_id>
    <nct_id>NCT01734044</nct_id>
  </id_info>
  <brief_title>rhTPO Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of ITP</brief_title>
  <official_title>A Multicentre Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (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>Shandong Provincial Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shenzhen Second People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>China Medical University, China</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known&#xD;
      hospitals in China. In order to report the efficacy and safety of Recombinant Human&#xD;
      thrombopoietin combining with Dexamethasone for the treatment of adults with primary immune&#xD;
      thrombocytopenia (ITP), compared to High-dose Dexamethasone therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators are undertaking a parallel group, multicentre, randomised controlled trial&#xD;
      of 200 primary ITP adult patients from 14 medical centers in China. One part of the&#xD;
      participants are randomly selected to receive recombinant human thrombopoietin (given&#xD;
      subcutaneously at a dose of 300Units/kg for7-14 consecutive days, following with a flexible&#xD;
      dosage depending on platelet count until the 28th day), combining with dexamethasone (given&#xD;
      intravenously at a dose of 40 mg per day for 4days, the others are selected to receive&#xD;
      high-dose of dexamethasone treatment (given intravenously at a dose of 40 mg daily for 4&#xD;
      days). Platelet count was evaluated before and after treatment, in order to report the&#xD;
      conversion ratio of primary ITP to chronic ITP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluation of platelet response</measure>
    <time_frame>up to 1 year per subject</time_frame>
    <description>Chronic ITP is defined as having platelet count less than 100×10^9/L,lasting for more than 12 months.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of platelet response (R)</measure>
    <time_frame>up to 1 year per subject</time_frame>
    <description>R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">158</enrollment>
  <condition>Purpura</condition>
  <condition>Idiopathic Thrombocytopenic Purpura</condition>
  <arm_group>
    <arm_group_label>combination treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 enrolled patients are randomly picked up to take rhTPO in combination with dexamethasone at the indicated dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>single treatment group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 enrolled patients are randomly picked up to take dexamethasone at the indicated dose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>recombinant human thrombopoietin (rhTPO); dexamethasone</intervention_name>
    <description>Patients in recombination treatment group take rhTPO( subcutaneously , 300U/kg for 14 consecutive days, followed by flexible treating dosage so as to keep the platelet count above 50×10^9/L until the 28th day), in combination with dexamethasone(intravenously , 40mg/d for 4 consecutive days)</description>
    <arm_group_label>combination treatment group</arm_group_label>
    <other_name>Recombinant Human Thrombopoietin</other_name>
    <other_name>Recombinant Human TPO</other_name>
    <other_name>rhTPO combine with Dexamethasone</other_name>
    <other_name>Recombinant Human Thrombopoietin combine with Dexamethasone</other_name>
    <other_name>Recombinant Human TPO combine with Dexamethasone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Patients in single treatment group take dexamethasone intravenously at 40 mg daily for 4 consecutive days.</description>
    <arm_group_label>single treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Meet the diagnostic criteria for immune thrombocytopenia.&#xD;
&#xD;
          2. Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80&#xD;
             years.&#xD;
&#xD;
          3. To show a platelet count &lt; 30×10^9/L, and with bleeding manifestations.&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.&#xD;
&#xD;
          5. Willing and able to sign written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts&#xD;
             within 3 months before the screening visit.&#xD;
&#xD;
          2. Received high-dose steroids or [2] intravenous immunoglobulin transfusion(IVIG)in the&#xD;
             3 weeks prior to the start of the study.&#xD;
&#xD;
          3. Current HIV infection or hepatitis B virus or hepatitis C virus infections.&#xD;
&#xD;
          4. Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or&#xD;
             uncontrolled disease or condition related to or impacting cardiac function (e.g.,&#xD;
             unstable angina, congestive heart failure, uncontrolled hypertension or cardiac&#xD;
             arrhythmia)&#xD;
&#xD;
          5. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate&#xD;
             pregnancy during the study period.&#xD;
&#xD;
          6. Have a known diagnosis of other autoimmune diseases, established in the medical&#xD;
             history and laboratory findings with positive results for the determination of&#xD;
             antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct&#xD;
             Coombs test.&#xD;
&#xD;
          7. Patients who are deemed unsuitable for the study by the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ming Hou, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shandong University</affiliation>
  </overall_official>
  <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>
  <results_reference>
    <citation>Cheng Y, Wong RS, Soo YO, Chui CH, Lau FY, Chan NP, Wong WS, Cheng G. Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone. N Engl J Med. 2003 Aug 28;349(9):831-6. doi: 10.1056/NEJMoa030254.</citation>
    <PMID>12944568</PMID>
  </results_reference>
  <results_reference>
    <citation>Mazzucconi MG, Fazi P, Bernasconi S, De Rossi G, Leone G, Gugliotta L, Vianelli N, Avvisati G, Rodeghiero F, Amendola A, Baronci C, Carbone C, Quattrin S, Fioritoni G, D'Alfonso G, Mandelli F; Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) Thrombocytopenia Working Party. Therapy with high-dose dexamethasone (HD-DXM) in previously untreated patients affected by idiopathic thrombocytopenic purpura: a GIMEMA experience. Blood. 2007 Feb 15;109(4):1401-7. doi: 10.1182/blood-2005-12-015222. Epub 2006 Oct 31.</citation>
    <PMID>17077333</PMID>
  </results_reference>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 21, 2012</study_first_submitted>
  <study_first_submitted_qc>November 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>April 18, 2016</last_update_submitted>
  <last_update_submitted_qc>April 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 20, 2016</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>Recombinant Human Thrombopoietin</keyword>
  <keyword>rhTPO</keyword>
  <keyword>Dexamethasone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Purpura</mesh_term>
    <mesh_term>Purpura, Thrombocytopenic</mesh_term>
    <mesh_term>Purpura, Thrombocytopenic, Idiopathic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>BB 1101</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/NCT01734044
org study id: ITP-007
nct id: NCT01734044
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known
      hospitals in China. In order to report the efficacy and safety of Recombinant Human
      thrombopoietin combining with Dexamethasone for the treatment of adults with primary immune
      thrombocytopenia (ITP), compared to High-dose Dexamethasone therapy.
The investigators are undertaking a parallel group, multicentre, randomised controlled trial
      of 200 primary ITP adult patients from 14 medical centers in China. One part of the
      participants are randomly selected to receive recombinant human thrombopoietin (given
      subcutaneously at a dose of 300Units/kg for7-14 consecutive days, following with a flexible
      dosage depending on platelet count until the 28th day), combining with dexamethasone (given
      intravenously at a dose of 40 mg per day for 4days, the others are selected to receive
      high-dose of dexamethasone treatment (given intravenously at a dose of 40 mg daily for 4
      days). Platelet count was evaluated before and after treatment, in order to report the
      conversion ratio of primary ITP to chronic ITP.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Evaluation of platelet response
time frame: up to 1 year per subject
description: Chronic ITP is defined as having platelet count less than 100×10^9/L,lasting for more than 12 months.
measure: Evaluation of platelet response (R)
time frame: up to 1 year per subject
description: R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia
arm group label: combination treatment group
arm group type: Experimental
description: 100 enrolled patients are randomly picked up to take rhTPO in combination with dexamethasone at the indicated dose.
arm group label: single treatment group
arm group type: Active Comparator
description: 100 enrolled patients are randomly picked up to take dexamethasone at the indicated dose.
intervention type: Drug
intervention name: recombinant human thrombopoietin (rhTPO); dexamethasone
description: Patients in recombination treatment group take rhTPO( subcutaneously , 300U/kg for 14 consecutive days, followed by flexible treating dosage so as to keep the platelet count above 50×10^9/L until the 28th day), in combination with dexamethasone(intravenously , 40mg/d for 4 consecutive days)
arm group label: combination treatment group
other name: Recombinant Human Thrombopoietin
other name: Recombinant Human TPO
other name: rhTPO combine with Dexamethasone
other name: Recombinant Human Thrombopoietin combine with Dexamethasone
other name: Recombinant Human TPO combine with Dexamethasone
intervention type: Drug
intervention name: Dexamethasone
description: Patients in single treatment group take dexamethasone intravenously at 40 mg daily for 4 consecutive days.
arm group label: single treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Ming Hou, Dr.
role: Principal Investigator
affiliation: Shandong University
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
citation: Cheng Y, Wong RS, Soo YO, Chui CH, Lau FY, Chan NP, Wong WS, Cheng G. Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone. N Engl J Med. 2003 Aug 28;349(9):831-6. doi: 10.1056/NEJMoa030254.
PMID: 12944568
citation: Mazzucconi MG, Fazi P, Bernasconi S, De Rossi G, Leone G, Gugliotta L, Vianelli N, Avvisati G, Rodeghiero F, Amendola A, Baronci C, Carbone C, Quattrin S, Fioritoni G, D'Alfonso G, Mandelli F; Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) Thrombocytopenia Working Party. Therapy with high-dose dexamethasone (HD-DXM) in previously untreated patients affected by idiopathic thrombocytopenic purpura: a GIMEMA experience. Blood. 2007 Feb 15;109(4):1401-7. doi: 10.1182/blood-2005-12-015222. Epub 2006 Oct 31.
PMID: 17077333
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Ming Hou
investigator title: Professor and Director
mesh term: Purpura
mesh term: Purpura, Thrombocytopenic
mesh term: Purpura, Thrombocytopenic, Idiopathic
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: BB 1101