<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/NCT02203422</url>
  </required_header>
  <id_info>
    <org_study_id>ITP-Cyclosporin A</org_study_id>
    <nct_id>NCT02203422</nct_id>
  </id_info>
  <brief_title>A Multicenter Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Cyclosporin A Versus Cyclosporin A in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia （ITP）</brief_title>
  <official_title>Recombinant Human Thrombopoietin (rhTPO) Combining Cyclosporin A Versus Cyclosporin A in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia （ITP）</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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 5 well-known&#xD;
      hospitals in China. In order to report the efficacy and safety of recombinant human&#xD;
      thrombopoietin combining with cyclosporin A for the treatment of adults with refractory&#xD;
      immune thrombocytopenia (ITP), compared to cyclosporin A monotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators are undertaking a parallel group, multicenter, randomized controlled trial&#xD;
      of 120 steroid-resistant/relapsed ITP adult patients from 6 medical centers in China. One&#xD;
      part of the participants are randomly selected to receive recombinant human thrombopoietin&#xD;
      (given subcutaneously at a dose of 300 Units/kg for 14 consecutive days, following with a&#xD;
      flexible dosage depending on platelet count until the 29th day), combining with cyclosporin A&#xD;
      (given orally at a dose of 1.5-2.0mg/kg twice daily for 3 consecutive months, adjusted to&#xD;
      maintain serum levels between 200-400 ng/ml and tapered by 50 mg/d per week if patients&#xD;
      achieved a complete response). The others are selected to receive cyclosporin A monotherapy&#xD;
      (given orally at a dose of 1.5-2.0mg/kg twice daily for 3 consecutive months, adjusted to&#xD;
      maintain serum levels between 200-400 ng/ml and tapered by 50 mg/d per week if patients&#xD;
      achieved a complete response). Platelet count, bleeding and other symptoms were evaluated&#xD;
      before and after treatment. Adverse events are also recorded throughout the study. In order&#xD;
      to report the efficacy and safety of the combination therapy compared to cyclosporin A&#xD;
      monotherapy for the treatment of adults with steroid-resistant/relapsed ITP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No eligible patient was enrolled.&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Anticipated">July 2015</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 (Complete Response)</measure>
    <time_frame>The time frame is up to 3 months per subject</time_frame>
    <description>CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of platelet response (Response)</measure>
    <time_frame>The time frame is up to 3 months 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>
  <primary_outcome>
    <measure>Evaluation of platelet response (No Response)</measure>
    <time_frame>The time frame is up to 3 months per subject</time_frame>
    <description>NR.No response (NR) was defined as platelet count &lt; 30 × 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of platelet response (relapses)</measure>
    <time_frame>The time frame is up to 3 months per subject</time_frame>
    <description>A relapses was defined as platelet count falls below 30×10^9/L or bleeding accrues after achieving R or CR.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The number and frequency of therapy associated adverse events The number and frequency of therapy associated adverse events The number and frequency of therapy associated adverse events The number and frequency of therapy associated adverse events</measure>
    <time_frame>up to 3 months per subject</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Immune Thrombocytopenia</condition>
  <arm_group>
    <arm_group_label>combination treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>60 enrolled patients are randomly picked up to take cyclosporin A in combination with rhTPO 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>60 enrolled patients are randomly picked up to take cyclosporin A at the indicated dose.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclosporin A</intervention_name>
    <description>given orally at a dose of 1.5-2.0mg/kg twice daily for 3 consecutive months, adjusted to maintain serum levels between 200-400 ng/ml and tapered by 50 mg/d per week if patients achieved a complete response.</description>
    <arm_group_label>combination treatment group</arm_group_label>
    <arm_group_label>single treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>rhTPO</intervention_name>
    <description>given subcutaneously at a dose of 300 Units/kg for 14 consecutive days, following with a flexible dosage depending on platelet count until the 29th day</description>
    <arm_group_label>combination treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Meet the diagnostic criteria for immune thrombocytopenia.&#xD;
&#xD;
          2. Steroid-resistant/relapsed hospitalized patients, may be male or female, between the&#xD;
             ages of 18-80 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. Current HIV infection or hepatitis B virus or hepatitis C virus infections. 3.Severe&#xD;
             medical condition (lung, hepatic or renal disorder) other than ITP. 4.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 history&#xD;
        and laboratory findings with positive results for the determination of antinuclear&#xD;
        antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct 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>80 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>
        <zip>250012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</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>Immune Thrombocytopenia</keyword>
  <keyword>Recombinant Human Thrombopoietin</keyword>
  <keyword>Cyclosporin A</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombocytopenia</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>Cyclosporine</mesh_term>
    <mesh_term>Cyclosporins</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/NCT02203422
org study id: ITP-Cyclosporin A
nct id: NCT02203422
lead sponsor: 
has dmc: Yes
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 recombinant human
      thrombopoietin combining with cyclosporin A for the treatment of adults with refractory
      immune thrombocytopenia (ITP), compared to cyclosporin A monotherapy.
The investigators are undertaking a parallel group, multicenter, randomized controlled trial
      of 120 steroid-resistant/relapsed ITP adult patients from 6 medical centers in China. One
      part of the participants are randomly selected to receive recombinant human thrombopoietin
      (given subcutaneously at a dose of 300 Units/kg for 14 consecutive days, following with a
      flexible dosage depending on platelet count until the 29th day), combining with cyclosporin A
      (given orally at a dose of 1.5-2.0mg/kg twice daily for 3 consecutive months, adjusted to
      maintain serum levels between 200-400 ng/ml and tapered by 50 mg/d per week if patients
      achieved a complete response). The others are selected to receive cyclosporin A monotherapy
      (given orally at a dose of 1.5-2.0mg/kg twice daily for 3 consecutive months, adjusted to
      maintain serum levels between 200-400 ng/ml and tapered by 50 mg/d per week if patients
      achieved a complete response). 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 the combination therapy compared to cyclosporin A
      monotherapy for the treatment of adults with steroid-resistant/relapsed ITP.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Evaluation of platelet response (Complete Response)
time frame: The time frame is up to 3 months per subject
description: CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L
measure: Evaluation of platelet response (Response)
time frame: The time frame is up to 3 months per subject
description: R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia.
measure: Evaluation of platelet response (No Response)
time frame: The time frame is up to 3 months per subject
description: NR.No response (NR) was defined as platelet count < 30 × 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.
measure: Evaluation of platelet response (relapses)
time frame: The time frame is up to 3 months per subject
description: A relapses was defined as platelet count falls below 30×10^9/L or bleeding accrues after achieving R or CR.
measure: The number and frequency of therapy associated adverse events The number and frequency of therapy associated adverse events The number and frequency of therapy associated adverse events The number and frequency of therapy associated adverse events
time frame: up to 3 months per subject
arm group label: combination treatment group
arm group type: Experimental
description: 60 enrolled patients are randomly picked up to take cyclosporin A in combination with rhTPO at the indicated dose.
arm group label: single treatment group
arm group type: Active Comparator
description: 60 enrolled patients are randomly picked up to take cyclosporin A at the indicated dose.
intervention type: Drug
intervention name: Cyclosporin A
description: given orally at a dose of 1.5-2.0mg/kg twice daily for 3 consecutive months, adjusted to maintain serum levels between 200-400 ng/ml and tapered by 50 mg/d per week if patients achieved a complete response.
arm group label: combination treatment group
arm group label: single treatment group
intervention type: Drug
intervention name: rhTPO
description: given subcutaneously at a dose of 300 Units/kg for 14 consecutive days, following with a flexible dosage depending on platelet count until the 29th day
arm group label: combination treatment group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ming Hou, Dr.
role: Principal Investigator
affiliation: Shandong University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Ming Hou
investigator title: Professor and Director
mesh term: Thrombocytopenia
mesh term: Purpura, Thrombocytopenic, Idiopathic
mesh term: Cyclosporine
mesh term: Cyclosporins