<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/NCT03838354</url>
  </required_header>
  <id_info>
    <org_study_id>ITP-Chidamide</org_study_id>
    <nct_id>NCT03838354</nct_id>
  </id_info>
  <brief_title>A Clinical Trial of the Low Dose Chidamide in the Management of Refractory ITP</brief_title>
  <official_title>A Prospective, Single-arm Clinical Trial of the Low Dose Chidamide in the Management of Refractory Immune Thrombocytopenia</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nowdays HDACi's were more and more focused on the anti-inflammatory and immunomodulatory&#xD;
      activities,independent of their known proapoptotic or cell cycle arrest actions on malignant&#xD;
      cells. Low concentrations of HDACi's are effective in reducing inflammation and autoimmune&#xD;
      response in humans with juvenile idiopathic arthritis and animal models of inflammatory bowel&#xD;
      disease and arthritis. The project was undertaking by Qilu Hospital of Shandong University in&#xD;
      China. In order to report the efficacy and safety of the low dose chidamide in the management&#xD;
      of refractory ITP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators are undertaking a prospective, open, multicentre trial of 30 refractory ITP&#xD;
      adult patients from 5 medical centers in China. 1/2 of the participants are randomly selected&#xD;
      to receive Chidamide in 2.5 mg po tiw, every four weeks for one cycle and it will be given&#xD;
      three cycles. The other part will receive Chidamide in 5 mg po tiw, every four weeks for one&#xD;
      cycle and it will be given three cycles. The treatment was discontinued after 3 months&#xD;
      without blood index reaction. 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 low dose chidamide in the management of refractory&#xD;
      ITP.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">March 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>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Platelet count</measure>
    <time_frame>the third month after the first dose of Chidamide</time_frame>
    <description>Platelet count will be observed at the third month after the first dose of Chidamide</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Therapy associated adverse events</measure>
    <time_frame>up to 1 year per subject</time_frame>
    <description>The number and frequency of therapy associated adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Thrombocytopenia</condition>
  <arm_group>
    <arm_group_label>A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chidamide 2.5 mg po tiw</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chidamide 5 mg po tiw</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chidamide</intervention_name>
    <description>Chidamide 2.5 mg po biw, every four weeks for one cycle. It will be given three cycles.</description>
    <arm_group_label>A</arm_group_label>
    <other_name>HBI-8000</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Chidamide</intervention_name>
    <description>Chidamide 5 mg po biw, every four weeks for one cycle. It will be given three cycles.</description>
    <arm_group_label>B</arm_group_label>
    <other_name>HBI-8000</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Refractory ITP patients need of treatment(s) to minimize the risk of clinically&#xD;
             significant bleeding primary ITP confirmed by excluding other supervened causes of&#xD;
             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>
  <overall_contact>
    <last_name>Ming Hou, doctor</last_name>
    <phone>0531-82169879</phone>
    <email>houming@medmail.com.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Qilu hospital, Shandong University</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>ming hou, doctor</last_name>
      <email>houming@medmail.com.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</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>Chidamide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombocytopenia</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/NCT03838354
org study id: ITP-Chidamide
nct id: NCT03838354
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Nowdays HDACi's were more and more focused on the anti-inflammatory and immunomodulatory
      activities,independent of their known proapoptotic or cell cycle arrest actions on malignant
      cells. Low concentrations of HDACi's are effective in reducing inflammation and autoimmune
      response in humans with juvenile idiopathic arthritis and animal models of inflammatory bowel
      disease and arthritis. The project was undertaking by Qilu Hospital of Shandong University in
      China. In order to report the efficacy and safety of the low dose chidamide in the management
      of refractory ITP.
The investigators are undertaking a prospective, open, multicentre trial of 30 refractory ITP
      adult patients from 5 medical centers in China. 1/2 of the participants are randomly selected
      to receive Chidamide in 2.5 mg po tiw, every four weeks for one cycle and it will be given
      three cycles. The other part will receive Chidamide in 5 mg po tiw, every four weeks for one
      cycle and it will be given three cycles. The treatment was discontinued after 3 months
      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 the low dose chidamide in the management of refractory
      ITP.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Platelet count
time frame: the third month after the first dose of Chidamide
description: Platelet count will be observed at the third month after the first dose of Chidamide
measure: Therapy associated adverse events
time frame: up to 1 year per subject
description: The number and frequency of therapy associated adverse events
arm group label: A
arm group type: Experimental
description: Chidamide 2.5 mg po tiw
arm group label: B
arm group type: Experimental
description: Chidamide 5 mg po tiw
intervention type: Drug
intervention name: Chidamide
description: Chidamide 2.5 mg po biw, every four weeks for one cycle. It will be given three cycles.
arm group label: A
other name: HBI-8000
intervention type: Drug
intervention name: Chidamide
description: Chidamide 5 mg po biw, every four weeks for one cycle. It will be given three cycles.
arm group label: B
other name: HBI-8000
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ming Hou, doctor
phone: 0531-82169879
email: houming@medmail.com.cn
facility: 
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shandong University
investigator full name: Ming Hou
investigator title: Professor and Director
mesh term: Thrombocytopenia