<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/NCT04447183</url>
  </required_header>
  <id_info>
    <org_study_id>ZGTSH002</org_study_id>
    <nct_id>NCT04447183</nct_id>
  </id_info>
  <brief_title>The Safety and Effectiveness of rhTSH in Radioiodine Treatment for Patients With Differentiated Thyroid Cancer.</brief_title>
  <acronym>DTC</acronym>
  <official_title>A Phase II Study of the Safety and Effectiveness of rhTSH in Radioiodine Treatment for Patients With Differentiated Thyroid Cancer.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Suzhou Zelgen Biopharmaceuticals Co.,Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Suzhou Zelgen Biopharmaceuticals 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 randomized, open, parallel controlled, multi-center clinical trial; 120 subjects&#xD;
      were randomly assigned to the test group and the control group according to 3:1.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was conducted in patients with differentiated thyroid cancer who had undergone&#xD;
      near-total thyroidectomy. After surgery patients were randomized to one of two methods of&#xD;
      performing thyroid remnant ablation (use of radioiodine to remove any remaining thyroid&#xD;
      tissue). One group of patients who took thyroid hormone medicine and were euthyroid [i.e.&#xD;
      their thyroid stimulating hormone (TSH) levels are normal], and received injections of&#xD;
      Thyrogen (0.9 mg daily on two consecutive days) followed by oral radioiodine. The second&#xD;
      group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e.&#xD;
      their TSH levels were high), and were given oral radioiodine. All patients received the same&#xD;
      amount of radioactive iodine (30mCi±1.5mCi or 1.11GBq of 131I). Approximately 9 months later,&#xD;
      whole body scans were performed on all patients to learn whether the thyroid remnants had&#xD;
      been successfully ablated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 23, 2020</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">August 2023</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>Parallel Assignment</intervention_model>
    <intervention_model_description>A randomized, open, parallel controlled, multi-center clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ablation success rate by Diagnostic Whole Body Scan (DxWBS)</measure>
    <time_frame>at week 36</time_frame>
    <description>In the THW state (TSH≥30mU/L), DxWBS showed the proportion of subjects who did not see radioactive iodine uptake in the thyroid gland.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum thyroglobulin (Tg) levels</measure>
    <time_frame>at week 36</time_frame>
    <description>In the THW state (TSH≥30mU/L), the proportion of patients with Tg levels &lt;1ng/mL and neck B-ultrasound negative during rhTSH stimulation accounted for all subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Event</measure>
    <time_frame>up to week 40 ± 7 day</time_frame>
    <description>Classification and degree of adverse events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Differentiated Thyroid Cancer</condition>
  <arm_group>
    <arm_group_label>Test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The test group of patients who took thyroid hormone medicine and were euthyroid [i.e. their thyroid stimulating hormone (TSH) levels are normal], and received injections of Thyrogen (0.9 mg daily on two consecutive days) followed by oral radioiodine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The control group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high,TSH≥30mU/L), and were given oral radioiodine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH)</intervention_name>
    <description>rhTSH: 0.9 mg IM daily on two consecutive days;radioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral</description>
    <arm_group_label>Test group</arm_group_label>
    <other_name>radioactive iodine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>radioactive iodine</intervention_name>
    <description>radioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Test group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathological diagnosis of differentiated thyroid cancer, including papillary thyroid&#xD;
             cancer (including papillary carcinoma follicular subtype), follicular thyroid cancer,&#xD;
             and Hurthle cell thyroid cancer;&#xD;
&#xD;
          -  Patients who were at 18~75 years old (male or female).&#xD;
&#xD;
          -  Patients with a total or near-total thyroidectomy within 12 weeks prior to enrollment&#xD;
             and plan to performing radioactive iodine((131)Ⅰ) thyroid remnant ablation.&#xD;
&#xD;
          -  Serum TSH ≤ 0.5 mU/L；&#xD;
&#xD;
          -  Women of childbearing age are HCG-negative;&#xD;
&#xD;
          -  Low iodine diet before enrollment for more than 4 weeks;&#xD;
&#xD;
          -  Patients are voluntarily enrolled, and written informed consent forms can be used for&#xD;
             treatment and visits as required by the program.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any significant clinical and laboratory abnormalities (eg, severe cardiopulmonary&#xD;
             disease, hepatic insufficiency, renal function Incomplete, congestive heart failure,&#xD;
             advanced lung disease or advanced cardiovascular and cerebrovascular disease, active&#xD;
             infection);&#xD;
&#xD;
          -  Patients who have used any water-soluble radiographic contrast agent intravenously,&#xD;
             underwent intrathecal iodine angiography or gallbladder iodine imaging within 3 months&#xD;
             before administration;&#xD;
&#xD;
          -  Taken/eaten within 4 weeks prior to administration Drugs/foods that affect iodine&#xD;
             uptake or metabolism, such as multivitamins, glucocorticoids, diuretics, lithium,&#xD;
             thiouracil, tazobactam, algae, iodine (except thyroid hormone replacement therapy);&#xD;
&#xD;
          -  Before administration Stroke, unstable angina (CCS class II or higher), atrial&#xD;
             fibrillation or medication (within beta blocker or digoxin) within 6 months Patients&#xD;
             with a history of arrhythmia;&#xD;
&#xD;
          -  Pregnant or lactating women;&#xD;
&#xD;
          -  Patients who are allergic to rhTSH and its excipients;&#xD;
&#xD;
          -  Patients with positive infection-related tests : Includes hepatitis C、syphilis and&#xD;
             AIDS;&#xD;
&#xD;
          -  Participated in any drug or medical device clinical trial within 1 month prior to the&#xD;
             trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yansong Lin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Thyroid Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iodine</mesh_term>
    <mesh_term>Hormones</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04447183
org study id: ZGTSH002
nct id: NCT04447183
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a randomized, open, parallel controlled, multi-center clinical trial; 120 subjects
      were randomly assigned to the test group and the control group according to 3:1.
This study was conducted in patients with differentiated thyroid cancer who had undergone
      near-total thyroidectomy. After surgery patients were randomized to one of two methods of
      performing thyroid remnant ablation (use of radioiodine to remove any remaining thyroid
      tissue). One group of patients who took thyroid hormone medicine and were euthyroid [i.e.
      their thyroid stimulating hormone (TSH) levels are normal], and received injections of
      Thyrogen (0.9 mg daily on two consecutive days) followed by oral radioiodine. The second
      group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e.
      their TSH levels were high), and were given oral radioiodine. All patients received the same
      amount of radioactive iodine (30mCi±1.5mCi or 1.11GBq of 131I). Approximately 9 months later,
      whole body scans were performed on all patients to learn whether the thyroid remnants had
      been successfully ablated.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomized, open, parallel controlled, multi-center clinical trial
primary purpose: Treatment
masking: None (Open Label)
measure: Ablation success rate by Diagnostic Whole Body Scan (DxWBS)
time frame: at week 36
description: In the THW state (TSH≥30mU/L), DxWBS showed the proportion of subjects who did not see radioactive iodine uptake in the thyroid gland.
measure: Serum thyroglobulin (Tg) levels
time frame: at week 36
description: In the THW state (TSH≥30mU/L), the proportion of patients with Tg levels <1ng/mL and neck B-ultrasound negative during rhTSH stimulation accounted for all subjects.
measure: Adverse Event
time frame: up to week 40 ± 7 day
description: Classification and degree of adverse events
arm group label: Test group
arm group type: Experimental
description: The test group of patients who took thyroid hormone medicine and were euthyroid [i.e. their thyroid stimulating hormone (TSH) levels are normal], and received injections of Thyrogen (0.9 mg daily on two consecutive days) followed by oral radioiodine.
arm group label: Control group
arm group type: Experimental
description: The control group of patients did not take thyroid hormone medicine so that they were hypothyroid (i.e. their TSH levels were high,TSH≥30mU/L), and were given oral radioiodine.
intervention type: Drug
intervention name: Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH)
description: rhTSH: 0.9 mg IM daily on two consecutive days;radioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral
arm group label: Test group
other name: radioactive iodine
intervention type: Other
intervention name: radioactive iodine
description: radioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral
arm group label: Control group
arm group label: Test group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yansong Lin, PhD
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Thyroid Neoplasms
mesh term: Thyroid Diseases
mesh term: Iodine
mesh term: Hormones
sharing ipd: No