<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/NCT02995707</url>
  </required_header>
  <id_info>
    <org_study_id>303PLA</org_study_id>
    <nct_id>NCT02995707</nct_id>
  </id_info>
  <brief_title>The Effective and Safety of Thalidomide in NTDT</brief_title>
  <official_title>The Phase II Clinical Trials of Thalidomide in NTDT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xiao-Lin Yin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>303rd Hospital of the People's Liberation Army</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an exploratory experiment, aims to explore the effective and safety of thalidomide in&#xD;
      the treatment of NTDT to improve the hemoglobin level, improve the quality of life, reduce&#xD;
      blood transfusion, so as to avoid the adverse reactions caused by transfusion.15~30 patients&#xD;
      will be enrolled, including type α 5~13 cases, type β 10~17 cases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The project is a single arm research of thalidomide in NTDT,patients volunteered to&#xD;
      participate in this trial and met the following inclusion criteria will be enrolled: age from&#xD;
      18~65, Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.&#xD;
      Subjects should take thalidomide 50mg per day for 12 weeks. During this time, hepatic and&#xD;
      renal function, hematologic function, electrocardiogram and the adverse reactions were&#xD;
      closely observed. According to the protocol, the blood routine, peripheral blood reticulocyte&#xD;
      count, nucleated red blood cell count, hemoglobin electrophoresis and other indicators were&#xD;
      evaluated in screening-period visit, 4-weeks visit, 8-weeks visit and 12-weeks visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</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>The level of Hemoglobin</measure>
    <time_frame>18 months</time_frame>
    <description>All participants will complete the treatment for 18 months, the hemoglobin levels will be observed during the treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The effects of relative and absolute values of HbF</measure>
    <time_frame>18 months</time_frame>
    <description>The highest hemoglobin value will be observed,the value increased more than 20g/L defined as the marked effect, increased to 10~20g/L defined as effective, otherwise invalid.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Thalassemia</condition>
  <arm_group>
    <arm_group_label>thalidomide thalassemia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>thalidomide:50mg/d p.o</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Thalidomide</intervention_name>
    <description>thalidomide:50mg/d p.o at bedtime</description>
    <arm_group_label>thalidomide thalassemia</arm_group_label>
    <other_name>fǎn yìng tíng</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients meeting all of the following criteria will be considered for admission to the&#xD;
        trial:&#xD;
&#xD;
          -  Diagnosis of NTDT;&#xD;
&#xD;
          -  Ages 18-65 years;&#xD;
&#xD;
          -  ECOG: 0~2 scores;&#xD;
&#xD;
          -  Sign an informed consent agreeing to the clinical trial participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients presenting with any of the following criteria will not be included in the trial:&#xD;
&#xD;
          -  Patients received hydroxycarbamide, Yisui Shengxue Granule in three months;&#xD;
&#xD;
          -  Women during Pregnancy, breastfeeding or those of childbearing age who do not want to&#xD;
             take contraceptive measures;&#xD;
&#xD;
          -  Patients had comorbidities like severe heart or lung diseases, liver dysfunction,&#xD;
             cerebrovascular, cardiovascular, liver, kidney, tumor or other serious primary&#xD;
             diseases;&#xD;
&#xD;
          -  Patients Allergic to the drug ingredients;&#xD;
&#xD;
          -  Patients with any Mental problem;&#xD;
&#xD;
          -  Patients had Participated in other drug clinical trials in the past 1 month;&#xD;
&#xD;
          -  Patients had a history of venous or arterial thrombosis;&#xD;
&#xD;
          -  In certain circumstances that the researchers determined it was not suitable for the&#xD;
             research.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yin X Lin, director</last_name>
    <role>Study Director</role>
    <affiliation>NO.3 Hospital of the Chinese People's Liberation Army</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Liu Ch xu, President</last_name>
    <phone>0771 2870303</phone>
    <email>530369641@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>NO.3 Hospital of the Chinese People's Liberation Army</name>
      <address>
        <city>Nanjing</city>
        <state>Guangxi</state>
        <zip>530021</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Li L zhu, Assistant</last_name>
      <phone>0771 2870303</phone>
      <email>530369641@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>March 21, 2017</last_update_submitted>
  <last_update_submitted_qc>March 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>303rd Hospital of the People's Liberation Army</investigator_affiliation>
    <investigator_full_name>Xiao-Lin Yin</investigator_full_name>
    <investigator_title>Director, NO.3 Hospital of the People's Liberation Army</investigator_title>
  </responsible_party>
  <keyword>Thalidomide NTDT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thalassemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thalidomide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Three months later after the last visit，summery report will be shared with other researchers through database.</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>June 11, 2017</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>June 12, 2017</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>August 1, 2017</submitted>
    <returned>August 29, 2017</returned>
    <submitted>September 15, 2017</submitted>
    <returned>October 12, 2017</returned>
    <submitted>October 25, 2017</submitted>
    <returned>July 27, 2018</returned>
    <submitted>August 13, 2018</submitted>
    <returned>January 18, 2019</returned>
  </pending_results>
  <!-- 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/NCT02995707
org study id: 303PLA
nct id: NCT02995707
lead sponsor: 
has dmc: No
This is an exploratory experiment, aims to explore the effective and safety of thalidomide in
      the treatment of NTDT to improve the hemoglobin level, improve the quality of life, reduce
      blood transfusion, so as to avoid the adverse reactions caused by transfusion.15~30 patients
      will be enrolled, including type α 5~13 cases, type β 10~17 cases.
The project is a single arm research of thalidomide in NTDT,patients volunteered to
      participate in this trial and met the following inclusion criteria will be enrolled: age from
      18~65, Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less.
      Subjects should take thalidomide 50mg per day for 12 weeks. During this time, hepatic and
      renal function, hematologic function, electrocardiogram and the adverse reactions were
      closely observed. According to the protocol, the blood routine, peripheral blood reticulocyte
      count, nucleated red blood cell count, hemoglobin electrophoresis and other indicators were
      evaluated in screening-period visit, 4-weeks visit, 8-weeks visit and 12-weeks visit.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The level of Hemoglobin
time frame: 18 months
description: All participants will complete the treatment for 18 months, the hemoglobin levels will be observed during the treatment.
measure: The effects of relative and absolute values of HbF
time frame: 18 months
description: The highest hemoglobin value will be observed,the value increased more than 20g/L defined as the marked effect, increased to 10~20g/L defined as effective, otherwise invalid.
arm group label: thalidomide thalassemia
arm group type: Experimental
description: thalidomide:50mg/d p.o
intervention type: Drug
intervention name: Thalidomide
description: thalidomide:50mg/d p.o at bedtime
arm group label: thalidomide thalassemia
other name: fǎn yìng tíng
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yin X Lin, director
role: Study Director
affiliation: NO.3 Hospital of the Chinese People's Liberation Army
last name: Liu Ch xu, President
phone: 0771 2870303
email: 530369641@qq.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: 303rd Hospital of the People's Liberation Army
investigator full name: Xiao-Lin Yin
investigator title: Director, NO.3 Hospital of the People's Liberation Army
mesh term: Thalassemia
mesh term: Thalidomide
sharing ipd: Yes
ipd description: Three months later after the last visit，summery report will be shared with other researchers through database.
submitted: June 11, 2017
submission canceled: Unknown
submitted: June 12, 2017
submission canceled: Unknown
submitted: August 1, 2017
returned: August 29, 2017
submitted: September 15, 2017
returned: October 12, 2017
submitted: October 25, 2017
returned: July 27, 2018
submitted: August 13, 2018
returned: January 18, 2019