xml: <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/NCT05995054</url>
    </required_header>
    <id_info>
      <org_study_id>2023CD20ITP</org_study_id>
      <nct_id>NCT05995054</nct_id>
    </id_info>
    <brief_title>A Prospective, One-arm and Open Clinical Study of Obinutuzumab in the Treatment of Immune Thrombocytopenia</brief_title>
    <acronym>2023CD20ITP</acronym>
    <official_title>A Prospective, One-arm and Open Clinical Study to Assess Safety and Efficacy of Anti-Human CD20 Monoclonal Antibody Obinutuzumab in the Treatment of Primary Immune Thrombocytopenia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institute of Hematology &amp; Blood Diseases Hospital, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Institute of Hematology &amp; Blood Diseases Hospital, China</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        To evaluate the safety and efficacy of Obinutuzumab in the treatment of immune&#xD;
        thrombocytopenia in patients who have not responded adequately or relapsed after first-line&#xD;
        treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Immune thrombocytopenia (ITP) is an organ-specific autoimmune disease, which is characterized&#xD;
        by decreased platelet count and skin and mucosal bleeding. ITP is a kind of disease with&#xD;
        increased platelet destruction and impaired platelet production caused by autoimmunity.&#xD;
        Conventional treatment of adult ITP includes first-line glucocorticoid and immunoglobulin&#xD;
        therapy, second line TPO and TPO receptor agonist, splenectomy and other immunosuppressive&#xD;
        treatments (such as rituximab, vincristine, azathioprine, etc.). ITP is one of the most&#xD;
        common hemorrhagic diseases. At present, the treatment response of ITP is not good, and a&#xD;
        considerable number of patients need drug maintenance treatment, which seriously affects the&#xD;
        quality of life of patients and increases the economic burden of patients. Therefore, there&#xD;
        is still a lack of effective treatment for adult ITP, especially for recurrent and refractory&#xD;
        ITP patients, which is one of the problems that have attracted more attention and need to be&#xD;
        solved urgently.&#xD;
  &#xD;
        Obinutuzumab is the first personalized type Ⅱ glycosylation engineered CD20 monoclonal&#xD;
        antibody. Studies have shown that compared with rituximab, obinutuzumab may improve its&#xD;
        efficacy in lymphoma by increasing DCD and ADCC effects and reducing drug resistance by&#xD;
        reducing CDC effects. In view of this, Obinutuzumab may have the same effect in the treatment&#xD;
        of ITP, and may be more effective in the treatment of ITP, but there is also a risk of poor&#xD;
        efficacy. At present, there is a lack of data on the efficacy and safety of Obinutuzumab in&#xD;
        the treatment of ITP in China.&#xD;
  &#xD;
        Therefore, the investigators designed this clinical trial to evaluate the safety and efficacy&#xD;
        of Obinutuzumab in the treatment of immune thrombocytopenia in patients who have not&#xD;
        responded adequately or relapsed after first-line treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 28, 2023</start_date>
    <completion_date type="Anticipated">August 2026</completion_date>
    <primary_completion_date type="Anticipated">August 2025</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 overall efficacy response after Obinutuzumab treatment within 12 weeks</measure>
      <time_frame>12 weeks</time_frame>
      <description>Overall response rate defined as proportion of subjects with a platelet count ≥ 30 × 10^9/L and at least 2-fold from baseline at the meanwhile within 12 weeks after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Evaluation of overall efficacy response after Obinutuzumab treatment within 8 weeks</measure>
      <time_frame>8 weeks</time_frame>
      <description>Overall response rate defined as proportion of subjects with a platelet count ≥ 30 × 10^9/L and at least 2-fold from baseline at the meanwhile within 8 weeks after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of overall efficacy response after Obinutuzumab treatment within 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>Overall response rate defined as proportion of subjects with a platelet count ≥ 30 × 10^9/L and at least 2-fold from baseline at the meanwhile within 6 months after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of overall efficacy response after Obinutuzumab treatment within 12 months</measure>
      <time_frame>12 months</time_frame>
      <description>Overall response rate defined as proportion of subjects with a platelet count ≥ 30 × 10^9/L and at least 2-fold from baseline at the meanwhile within 12 months after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of sustained response rate after Obinutuzumab treatment within 6 months</measure>
      <time_frame>6 months</time_frame>
      <description>Sustained response rate defined as proportion of subjects who keep a platelet count ≥ 30 × 10^9/L and at least 2-fold from baseline at the meanwhile at 6 months after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of sustained response rate after Obinutuzumab treatment within 12 months</measure>
      <time_frame>12 months</time_frame>
      <description>Sustained response rate defined as proportion of subjects who keep a platelet count ≥ 30 × 10^9/L and at least 2-fold from baseline at the meanwhile at 12 months after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to onset response</measure>
      <time_frame>12 months</time_frame>
      <description>Time to onset response defined as the time needed for subjects to have a platelet count ≥ 30 × 10^9/L and at least 2-fold from baseline at the meanwhile after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response</measure>
      <time_frame>12 months</time_frame>
      <description>The longest duration for which the subject sustained a platelet count ≥ 30 × 10^9/L and at least 2-fold from baseline at the meanwhile after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Emergency treatment after Obinutuzumab treatment within 12 weeks</measure>
      <time_frame>12 weeks</time_frame>
      <description>Percentage of subjects who received emergency treatment after Obinutuzumab treatment within 12 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Reduction of concomitant drug after Obinutuzumab treatment within 12 weeks</measure>
      <time_frame>12 weeks</time_frame>
      <description>Percentage of patients with reduced doses of corticosteroids and/or other concomitant immunosuppressive drugs at baseline by 12 weeks of Obinutuzumab treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of subjects with clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale after Obinutuzumab treatment within 12 weeks</measure>
      <time_frame>12 weeks</time_frame>
      <description>Changes of the subjects' numbers in WHO bleeding score after Anti-CD20 antibody treatment according to the reported World Health Organization's Bleeding Scale. The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>One-year recurrence-free survival rate</measure>
      <time_frame>12 months</time_frame>
      <description>Time from the start of treatment to the occurrence of a relapse or death event</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety of Anti-CD20 antibody treatment</measure>
      <time_frame>12 months</time_frame>
      <description>Incidence, severity, and relationship of treatment emergent adverse events after Anti-CD20 antibody treatment</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">110</enrollment>
    <condition>Immune Thrombocytopenia</condition>
    <condition>Treatment</condition>
    <arm_group>
      <arm_group_label>Intervention (Obinutuzumab)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>110 enrolled subjects: one infusion</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Obinutuzumab Injection [Gazyva]</intervention_name>
      <description>intravenous Obinutuzumab administration&#xD;
  This study adopts a prospective, single arm, open design method. 110 subjects were enrolled in the study and were treated with CD20 monoclonal antibody (Obinutuzumab: 1000mg) for once.&#xD;
  The first stage is the main research stage (d1-w12), which is the core treatment period. The subjects will receive intravenous infusion of 1000mg Obinutuzumab for once to observe the safety and efficacy during treatment.&#xD;
  The second stage (w12-w48) is the stage of withdrawal from the visit, mainly to observe the safety and continuous efficacy of Obinutuzumab after treatment.</description>
      <arm_group_label>Intervention (Obinutuzumab)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 and above, male or female&#xD;
  &#xD;
            -  Conform to the diagnostic criteria of immune Thrombocytopenia (ITP)&#xD;
  &#xD;
            -  Diagnosis of ITP ≥3 months, and with a platelet count of &lt;30 X 109/L measured within 2&#xD;
               days prior to administration（Platelet counts were measured at least 2 times during&#xD;
               screening (at least 1 week apart) with platelets&lt;30 X 109/L）&#xD;
  &#xD;
            -  Failure to achieve response or relapse after corticosteroid therapy&#xD;
  &#xD;
            -  The previous emergency treatment of ITP (e.g. methylprednisolone, platelet&#xD;
               transfusion, IVIG transfusion) must be completed at least 2 weeks before the first&#xD;
               administration&#xD;
  &#xD;
            -  Signed and dated written informed consent&#xD;
  &#xD;
            -  With Liver and kidney function&lt;1.5×upper limit of normal， such as ALT、AST，BUN，Cre，etc.&#xD;
  &#xD;
            -  ECOG physical state score ≤ 2 points&#xD;
  &#xD;
            -  Cardiac function of the New York Society of Cardiac Function ≤ 2&#xD;
  &#xD;
            -  Patients receiving maintenance treatment (including corticosteroids (less than or&#xD;
               equal to 0.5mg/kg prednisone), TPO receptor agonists, etc.) must have a stable dose at&#xD;
               least 4 weeks before the first administration, and azathioprine, danazol, cyclosporin&#xD;
               A, tacrolimus, sirolimus, etc. must be stopped at least 4 weeks before the first&#xD;
               administration; The end of rituximab treatment was&gt;3 months；More than 6 months after&#xD;
               splenectomy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects with primary disease of important organs (liver, kidney, heart, etc.), or&#xD;
               with immune system diseases;&#xD;
  &#xD;
            -  Secondary thrombocytopenia caused by various reasons, such as connective tissue&#xD;
               disorders, bone marrow hematopoietic failure disease, myelodysplastic syndrome,&#xD;
               malignancy, drugs, inherited thrombocytopenia, common variable immune deficiency,&#xD;
               lymphoma, etc.;&#xD;
  &#xD;
            -  Subjects infected with human immunodeficiency virus (HIV);&#xD;
  &#xD;
            -  Uncontrollable or active infections during the screening period, including hepatitis&#xD;
               B, hepatitis C, cytomegalovirus, EB virus, or positive syphilis antigen;&#xD;
  &#xD;
            -  Subjects with extensive and severe bleeding, such as hemoptysis, upper&#xD;
               gastrointestinal hemorrhage, intracranial hemorrhage;&#xD;
  &#xD;
            -  Subjects with heart disease that requires treatment or hypertension that has been&#xD;
               judged by researchers to be poorly controlled currently;&#xD;
  &#xD;
            -  Subjects with any venous or arterial thrombosis, atherosclerosis, and other diseases;&#xD;
  &#xD;
            -  Subjects with a history of malignant solid tumor or have received allogeneic stem cell&#xD;
               transplantation or organ transplantation;&#xD;
  &#xD;
            -  Subjects with mental disorders who are unable to sign normal informed consent and&#xD;
               conduct trials and follow-up;&#xD;
  &#xD;
            -  Subjects whose toxic symptoms caused by pre-trial treatment have not disappeared;&#xD;
  &#xD;
            -  Subjects with other serious diseases that may limit their participation in this trial&#xD;
               (diabetes; severe cardiac insufficiency; myocardial obstruction or unstable arrhythmia&#xD;
               or unstable angina pectoris in the last 6 months; gastric ulcer; active autoimmune&#xD;
               disease, etc.);&#xD;
  &#xD;
            -  Subjects with septicemia or other irregular bleeding;&#xD;
  &#xD;
            -  Female subjects who are nursing or pregnant/suspected pregnant (positive pregnancy&#xD;
               tests for human chorionic gonadotropin in urine during screening).&#xD;
  &#xD;
            -  Patients taking antiplatelet drugs at the same time;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lei Zhang, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chinese Academy of Medical Science and Blood Disease Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yunfei Chen, MD</last_name>
      <phone>+8618502220788</phone>
      <email>chenyunfei@ihcams.ac.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Chinese Academy of Medical Science and Blood Disease Hospital</name>
        <address>
          <city>Tianjin</city>
          <zip>300020</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yunfei Chen, MD</last_name>
        <phone>+86-22-23909009</phone>
        <email>chenyunfei@ihcams.ac.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Institute of Hematology &amp; Blood Diseases Hospital, China</investigator_affiliation>
      <investigator_full_name>Zhang Lei, MD</investigator_full_name>
      <investigator_title>vice Director of Thrombosis and Hemostasis Center</investigator_title>
    </responsible_party>
    <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>Obinutuzumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months 36 months after study completion.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>12 months to 36 months after study completion</ipd_time_frame>
      <ipd_access_criteria>Upon request to PI</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05995054
  org study id: 2023CD20ITP
  nct id: NCT05995054
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  To evaluate the safety and efficacy of Obinutuzumab in the treatment of immune
        thrombocytopenia in patients who have not responded adequately or relapsed after first-line
        treatment.
  Immune thrombocytopenia (ITP) is an organ-specific autoimmune disease, which is characterized
        by decreased platelet count and skin and mucosal bleeding. ITP is a kind of disease with
        increased platelet destruction and impaired platelet production caused by autoimmunity.
        Conventional treatment of adult ITP includes first-line glucocorticoid and immunoglobulin
        therapy, second line TPO and TPO receptor agonist, splenectomy and other immunosuppressive
        treatments (such as rituximab, vincristine, azathioprine, etc.). ITP is one of the most
        common hemorrhagic diseases. At present, the treatment response of ITP is not good, and a
        considerable number of patients need drug maintenance treatment, which seriously affects the
        quality of life of patients and increases the economic burden of patients. Therefore, there
        is still a lack of effective treatment for adult ITP, especially for recurrent and refractory
        ITP patients, which is one of the problems that have attracted more attention and need to be
        solved urgently.
  
        Obinutuzumab is the first personalized type Ⅱ glycosylation engineered CD20 monoclonal
        antibody. Studies have shown that compared with rituximab, obinutuzumab may improve its
        efficacy in lymphoma by increasing DCD and ADCC effects and reducing drug resistance by
        reducing CDC effects. In view of this, Obinutuzumab may have the same effect in the treatment
        of ITP, and may be more effective in the treatment of ITP, but there is also a risk of poor
        efficacy. At present, there is a lack of data on the efficacy and safety of Obinutuzumab in
        the treatment of ITP in China.
  
        Therefore, the investigators designed this clinical trial to evaluate the safety and efficacy
        of Obinutuzumab in the treatment of immune thrombocytopenia in patients who have not
        responded adequately or relapsed after first-line treatment.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Evaluation of overall efficacy response after Obinutuzumab treatment within 12 weeks
  time frame: 12 weeks
  description: Overall response rate defined as proportion of subjects with a platelet count ≥ 30 × 10^9/L and at least 2-fold from baseline at the meanwhile within 12 weeks after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period
  measure: Evaluation of overall efficacy response after Obinutuzumab treatment within 8 weeks
  time frame: 8 weeks
  description: Overall response rate defined as proportion of subjects with a platelet count ≥ 30 × 10^9/L and at least 2-fold from baseline at the meanwhile within 8 weeks after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period
  measure: Evaluation of overall efficacy response after Obinutuzumab treatment within 6 months
  time frame: 6 months
  description: Overall response rate defined as proportion of subjects with a platelet count ≥ 30 × 10^9/L and at least 2-fold from baseline at the meanwhile within 6 months after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period
  measure: Evaluation of overall efficacy response after Obinutuzumab treatment within 12 months
  time frame: 12 months
  description: Overall response rate defined as proportion of subjects with a platelet count ≥ 30 × 10^9/L and at least 2-fold from baseline at the meanwhile within 12 months after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period
  measure: Evaluation of sustained response rate after Obinutuzumab treatment within 6 months
  time frame: 6 months
  description: Sustained response rate defined as proportion of subjects who keep a platelet count ≥ 30 × 10^9/L and at least 2-fold from baseline at the meanwhile at 6 months after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period
  measure: Evaluation of sustained response rate after Obinutuzumab treatment within 12 months
  time frame: 12 months
  description: Sustained response rate defined as proportion of subjects who keep a platelet count ≥ 30 × 10^9/L and at least 2-fold from baseline at the meanwhile at 12 months after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period
  measure: Time to onset response
  time frame: 12 months
  description: Time to onset response defined as the time needed for subjects to have a platelet count ≥ 30 × 10^9/L and at least 2-fold from baseline at the meanwhile after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period
  measure: Duration of response
  time frame: 12 months
  description: The longest duration for which the subject sustained a platelet count ≥ 30 × 10^9/L and at least 2-fold from baseline at the meanwhile after initial administration in absence of rescue therapy, and without having had dose increment of TPO-RA or corticosteroids during the study period
  measure: Emergency treatment after Obinutuzumab treatment within 12 weeks
  time frame: 12 weeks
  description: Percentage of subjects who received emergency treatment after Obinutuzumab treatment within 12 weeks
  measure: Reduction of concomitant drug after Obinutuzumab treatment within 12 weeks
  time frame: 12 weeks
  description: Percentage of patients with reduced doses of corticosteroids and/or other concomitant immunosuppressive drugs at baseline by 12 weeks of Obinutuzumab treatment
  measure: Number of subjects with clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale after Obinutuzumab treatment within 12 weeks
  time frame: 12 weeks
  description: Changes of the subjects' numbers in WHO bleeding score after Anti-CD20 antibody treatment according to the reported World Health Organization's Bleeding Scale. The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss.
  measure: One-year recurrence-free survival rate
  time frame: 12 months
  description: Time from the start of treatment to the occurrence of a relapse or death event
  measure: Safety of Anti-CD20 antibody treatment
  time frame: 12 months
  description: Incidence, severity, and relationship of treatment emergent adverse events after Anti-CD20 antibody treatment
  arm group label: Intervention (Obinutuzumab)
  arm group type: Experimental
  description: 110 enrolled subjects: one infusion
  intervention type: Drug
  intervention name: Obinutuzumab Injection [Gazyva]
  description: intravenous Obinutuzumab administration
  This study adopts a prospective, single arm, open design method. 110 subjects were enrolled in the study and were treated with CD20 monoclonal antibody (Obinutuzumab: 1000mg) for once.
  The first stage is the main research stage (d1-w12), which is the core treatment period. The subjects will receive intravenous infusion of 1000mg Obinutuzumab for once to observe the safety and efficacy during treatment.
  The second stage (w12-w48) is the stage of withdrawal from the visit, mainly to observe the safety and continuous efficacy of Obinutuzumab after treatment.
  arm group label: Intervention (Obinutuzumab)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lei Zhang, MD
  role: Principal Investigator
  affiliation: Chinese Academy of Medical Science and Blood Disease Hospital
  last name: Yunfei Chen, MD
  phone: +8618502220788
  email: chenyunfei@ihcams.ac.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Institute of Hematology & Blood Diseases Hospital, China
  investigator full name: Zhang Lei, MD
  investigator title: vice Director of Thrombosis and Hemostasis Center
  mesh term: Thrombocytopenia
  mesh term: Purpura, Thrombocytopenic, Idiopathic
  mesh term: Obinutuzumab
  sharing ipd: Yes
  ipd description: Researchers qualified can request the dataset, including de-identified individual subject data. Data may be requested from PI from 12 months 36 months after study completion.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: 12 months to 36 months after study completion
  ipd access criteria: Upon request to PI