<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/NCT03755258</url>
  </required_header>
  <id_info>
    <org_study_id>HISUN-GCK-Ib-01</org_study_id>
    <nct_id>NCT03755258</nct_id>
  </id_info>
  <brief_title>Trial of Ginsenoside Compound K (GCK) Tablet in Patients With Rheumatoid Arthritis</brief_title>
  <official_title>A Phase Ib Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GCK in Rheumatoid Arthritis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang Hisun Pharmaceutical Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zhejiang Hisun Pharmaceutical Co. Ltd.</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a phase Ib study to investigate the safety, pharmacokinetics and preliminary efficacy&#xD;
      of ginsenoside compound K (GCK) tablets in patients with rheumatoid arthritis. This study is&#xD;
      to be run in China involving 10-12 sites. It will enroll approximately 240 patients to ensure&#xD;
      128 randomized with active rheumatoid arthritis. The treatment period is 12 weeks and total&#xD;
      study duration per patient is approximately 14 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this double-blind, placebo-controlled, phase Ib study, 128 patients with active RA are&#xD;
      planned to be enrolled and randomly assigned 1:1:1:1 to receive placebo, or different doses&#xD;
      of GCK tablet (100/200/300 mg). This study will evaluate the safety, pharmacokinetics and&#xD;
      preliminary efficacy of GCK tablets in patients with rheumatoid arthritis&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 16, 2017</start_date>
  <completion_date type="Anticipated">December 11, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 11, 2019</primary_completion_date>
  <phase>Phase 1</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>
    <intervention_model_description>Multiple Ascending Dose, Multiple Groups, Multiple Centers</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double blind</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects reaching (the American College of Rheumatology response criteria 20 (ACR 20)</measure>
    <time_frame>Week 12</time_frame>
    <description>ACR 20 would be examined</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in DAS 28-CRP</measure>
    <time_frame>Week 4/8/12</time_frame>
    <description>DAS 28-CRP would be assessed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects reaching ACR 20</measure>
    <time_frame>Week 4/8</time_frame>
    <description>ACR 20 would be assessed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects reaching ACR 50 and 70</measure>
    <time_frame>Time Frame: Week 4/8/12</time_frame>
    <description>ACR 50 and 70 would be assessed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in ESR and CRP</measure>
    <time_frame>Time Frame: Week 4/8/12</time_frame>
    <description>ESR and CRP would assessed</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">128</enrollment>
  <condition>Early Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>GCK 100 mg group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GCK 100 mg+ Placebo 200 mg GCK tablet 100 mg + Placebo tablet 100 mgX2 tablets, once daily for 12 weeks (oral)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GCK 200 mg group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GCK 200 mg + Placebo 100 mg GCK tablet 100 mg X 2 tablets+ Placebo tablet 100 mg once daily for 12 weeks (oral)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GCK 300 mg group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GCK tablet 300 mg GCK tablet 100 mgX3 tablets once daily for 12 weeks (oral)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo of GCK group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo 300 mg Placebo tablet 100 mgX3 tablets, once daily for 12 weeks (oral)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GCK 100 mg + Placebo 200 mg</intervention_name>
    <description>GCK 100 mg + Placebo 200 mg, oral, 12 weeks</description>
    <arm_group_label>GCK 100 mg group</arm_group_label>
    <other_name>GCK</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GCK 200 mg + Placebo 100 mg</intervention_name>
    <description>GCK 200 mg + Placebo 100 mg, oral, 12 weeks</description>
    <arm_group_label>GCK 200 mg group</arm_group_label>
    <other_name>GCK</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>GCK 300 mg</intervention_name>
    <description>GCK 300 mg, oral, 12 weeks</description>
    <arm_group_label>GCK 300 mg group</arm_group_label>
    <other_name>GCK</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo 300mg</intervention_name>
    <description>Placebo 300mg, oral, 12 weeks</description>
    <arm_group_label>Placebo of GCK group</arm_group_label>
    <other_name>Placebo of GCK</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients have active RA as confirmed by the following criteria:&#xD;
&#xD;
               1. ≥ 4 swollen joints and ≥ 4 tender joints at screening and baseline using the&#xD;
                  DAS28 joint count.&#xD;
&#xD;
               2. ESR ≥ 28 mm/hour, or CRP ≥ 1.5 times ULN.&#xD;
&#xD;
          -  Patients on non-prohibited medications must receive stable dose for at least 2 weeks&#xD;
             prior to study drug administration and maintain an unchanged regimen during the study.&#xD;
&#xD;
          -  Patients who are able and wish to sign the informed consent and comply with the&#xD;
             requirements of the study protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients have prior exposure to any csDMARDs or bDMARDs.&#xD;
&#xD;
          -  Patients have received corticosteroids, or Chinese medicine preparations such as&#xD;
             tripterygium wilfordii, total glucosides of paeony for RA treatment.&#xD;
&#xD;
          -  Patients with fibromyalgia&#xD;
&#xD;
          -  Patients diagnosed with any systemic inflammatory disease other than RA, including but&#xD;
             not limited to juvenile chronic arthritis, spondyloarthropathy, Crohn's disease,&#xD;
             ulcerative colitis, psoriatic arthritis, active vasculitis or gout, and siccasyndrome.&#xD;
&#xD;
          -  Diagnosis of Felty Syndrome.&#xD;
&#xD;
          -  Any major surgery has been performed within 8 weeks prior to the study, or will be&#xD;
             performed during the study, from which investigators believe posing an unacceptable&#xD;
             risk to the patient.&#xD;
&#xD;
          -  Patient with cardiovascular, respiratory, liver, gastrointestinal, endocrine,&#xD;
             hematological, neurological or psychiatric disorders or any other serious and/or&#xD;
             unstable disease or medical history, or serious infection, and the investigators&#xD;
             believe that these diseases or history may pose risks in the case of taking research&#xD;
             drugs, or may interfere with the analysis of data.&#xD;
&#xD;
          -  Patients who are unable to carry on normal activity or to do active work or unable to&#xD;
             take care of themselves.&#xD;
&#xD;
          -  Patients with history of malignant tumors and lymphoproliferative diseases.&#xD;
&#xD;
          -  Patients with active HBV or HCV or history of HIV infection.&#xD;
&#xD;
          -  Active TB diagnosed during screening or with a history of active TB that has not been&#xD;
             appropriately treated.&#xD;
&#xD;
          -  Patients who are currently pregnant or breastfeeding.&#xD;
&#xD;
          -  Female patients of childbearing potential or male subjects with partners of&#xD;
             childbearing potential not willing to use a highly effective method of contraception&#xD;
             during the study and 28 days after last administration.&#xD;
&#xD;
          -  Patient who participated in any investigational drug study within three months.&#xD;
&#xD;
        Specific laboratory abnormality including:&#xD;
&#xD;
          1. AST or ALT &gt; 1.5 times ULN&#xD;
&#xD;
          2. Total bilirubin &gt; 1.5 times ULN&#xD;
&#xD;
          3. Hemoglobin ≤ 85 g/L&#xD;
&#xD;
          4. White blood cells count ≤ 3.5×109/L&#xD;
&#xD;
          5. Absolute neutrophil count &lt; 1.5×109/L&#xD;
&#xD;
          6. Lymphocyte Count &lt; 0.75×109/L&#xD;
&#xD;
          7. Platelet count &lt; 90×109/L&#xD;
&#xD;
          8. Creatinine &gt; ULN&#xD;
&#xD;
               -  Any other situation, in the opinion of the investigator, characterizes the&#xD;
                  subject as not being a good candidate for the study.&#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 Su, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jianwei Liao, Master</last_name>
    <phone>+8657688827869</phone>
    <email>jwliao@hisunpharm.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dong Xiao, PhD</last_name>
    <phone>+8657688827869</phone>
    <email>xiaodong@hisunpharm.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Rheumatology</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100010</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yin Su, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 25, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 25, 2018</last_update_submitted>
  <last_update_submitted_qc>November 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ginsenoside compound K tablet</keyword>
  <keyword>Rheumatoid Arthritis</keyword>
  <keyword>Phase Ib study</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</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/NCT03755258
org study id: HISUN-GCK-Ib-01
nct id: NCT03755258
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a phase Ib study to investigate the safety, pharmacokinetics and preliminary efficacy
      of ginsenoside compound K (GCK) tablets in patients with rheumatoid arthritis. This study is
      to be run in China involving 10-12 sites. It will enroll approximately 240 patients to ensure
      128 randomized with active rheumatoid arthritis. The treatment period is 12 weeks and total
      study duration per patient is approximately 14 weeks.
In this double-blind, placebo-controlled, phase Ib study, 128 patients with active RA are
      planned to be enrolled and randomly assigned 1:1:1:1 to receive placebo, or different doses
      of GCK tablet (100/200/300 mg). This study will evaluate the safety, pharmacokinetics and
      preliminary efficacy of GCK tablets in patients with rheumatoid arthritis
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Multiple Ascending Dose, Multiple Groups, Multiple Centers
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double blind
measure: Proportion of subjects reaching (the American College of Rheumatology response criteria 20 (ACR 20)
time frame: Week 12
description: ACR 20 would be examined
measure: Change from baseline in DAS 28-CRP
time frame: Week 4/8/12
description: DAS 28-CRP would be assessed
measure: Proportion of subjects reaching ACR 20
time frame: Week 4/8
description: ACR 20 would be assessed
measure: Proportion of subjects reaching ACR 50 and 70
time frame: Time Frame: Week 4/8/12
description: ACR 50 and 70 would be assessed
measure: Change from baseline in ESR and CRP
time frame: Time Frame: Week 4/8/12
description: ESR and CRP would assessed
arm group label: GCK 100 mg group
arm group type: Experimental
description: GCK 100 mg+ Placebo 200 mg GCK tablet 100 mg + Placebo tablet 100 mgX2 tablets, once daily for 12 weeks (oral)
arm group label: GCK 200 mg group
arm group type: Experimental
description: GCK 200 mg + Placebo 100 mg GCK tablet 100 mg X 2 tablets+ Placebo tablet 100 mg once daily for 12 weeks (oral)
arm group label: GCK 300 mg group
arm group type: Experimental
description: GCK tablet 300 mg GCK tablet 100 mgX3 tablets once daily for 12 weeks (oral)
arm group label: Placebo of GCK group
arm group type: Placebo Comparator
description: Placebo 300 mg Placebo tablet 100 mgX3 tablets, once daily for 12 weeks (oral)
intervention type: Drug
intervention name: GCK 100 mg + Placebo 200 mg
description: GCK 100 mg + Placebo 200 mg, oral, 12 weeks
arm group label: GCK 100 mg group
other name: GCK
intervention type: Drug
intervention name: GCK 200 mg + Placebo 100 mg
description: GCK 200 mg + Placebo 100 mg, oral, 12 weeks
arm group label: GCK 200 mg group
other name: GCK
intervention type: Drug
intervention name: GCK 300 mg
description: GCK 300 mg, oral, 12 weeks
arm group label: GCK 300 mg group
other name: GCK
intervention type: Drug
intervention name: Placebo 300mg
description: Placebo 300mg, oral, 12 weeks
arm group label: Placebo of GCK group
other name: Placebo of GCK
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Yin Su, PhD
role: Principal Investigator
affiliation: Peking University People's Hospital
last name: Jianwei Liao, Master
phone: +8657688827869
email: jwliao@hisunpharm.com
last name: Dong Xiao, PhD
phone: +8657688827869
email: xiaodong@hisunpharm.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid