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/NCT05991531</url>
    </required_header>
    <id_info>
      <org_study_id>Serum HBV RNA</org_study_id>
      <nct_id>NCT05991531</nct_id>
    </id_info>
    <brief_title>Dynamic Changes of Serum HBV RNA in Chronic Hepatitis B Patients</brief_title>
    <official_title>Dynamic Changes of Serum HBV RNA in Chronic Hepatitis B Patients With Low Level HBV DNA Treated With Nucleoside (Acid) Analogues</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beijing Friendship Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beijing Friendship Hospital</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>
        Some patients with low-level viremia (LLV) are also likely to develop hepatocellular&#xD;
        carcinoma (HCC) or other liver diseases. The relationship between HBV RNA levels and fibrosis&#xD;
        in patients with HBV DNA negative or LLV is still lacking evidence. The purpose of this study&#xD;
        is to observe the differences in HBV RNA levels and their association with efficacy in HBV&#xD;
        DNA negative or LLV patients. Investigators conduct the prospective, single-center,&#xD;
        non-randomized, observational clinical study. A total of 100 chronic hepatitis B (CHB)&#xD;
        patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years will be&#xD;
        enrolled. The enrolled patients will be followed up five times to collect clinical data and&#xD;
        record adverse events (at baseline, week 12, week 24, week 36 and week 48, respectively).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 15, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The decrease of HBV RNA from baseline to 48 weeks</measure>
      <time_frame>2023.8-2025.8</time_frame>
      <description>The investigators detect the dynamic change of HBV RNA and the decline from baseline to 48 weeks;</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>HBV RNA undetectable rate at 48 weeks;</measure>
      <time_frame>2023.8-2025.8</time_frame>
      <description>After 48 weeks of treatment after enrollment, the investigators detect the HBV RNA undetectable rate 48 weeks;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The association of the dynamic changes of serum HBV RNA levels with HBsAg and HBeAg levels;</measure>
      <time_frame>2023.8-2025.8</time_frame>
      <description>During 48 weeks of treatment, the investigators detect the association of the dynamic changes of serum HBV RNA levels with HBsAg and HBeAg levels;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The association of HBV RNA changes with the liver stiffness;</measure>
      <time_frame>2023.8-2025.8</time_frame>
      <description>During 48 weeks of treatment, the investigators detect the association of HBV RNA changes with the liver stiffness;</description>
    </secondary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Chronic Hepatitis B Patients</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years and&#xD;
          with HBV DNA negative or LLV.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1.18 years old or above and the gender is not limited;&#xD;
  &#xD;
            -  2. Patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3&#xD;
               years ;&#xD;
  &#xD;
            -  3. Patients with HBV DNA negative (HBV DNA&lt;20 IU/ml) or LLV（HBV DNA 20-2000 IU/mL）&#xD;
  &#xD;
            -  4. Good compliance and voluntary signing of informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. Patients with decompensated cirrhosis;&#xD;
  &#xD;
            -  2. Patients co-infection with other viruses, such as hepatitis A virus, hepatitis C&#xD;
               virus, hepatitis D virus, hepatitis E virus, HIV virus, etc.;&#xD;
  &#xD;
            -  3. Patients with significant renal, cardiovascular, pulmonary, or neurological&#xD;
               disease;&#xD;
  &#xD;
            -  4. Patients have active or suspected malignancy or history of malignancy;&#xD;
  &#xD;
            -  5. Patients who were identified not appropriate for the study by investigators.&#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_contact>
      <last_name>Hong Ma, Profession</last_name>
      <phone>010-63138747</phone>
      <email>mahongmd@aliyun.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jialing Zhou, Associate research fellow</last_name>
      <email>zhoujialing11@126.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Beijing Friendship Hospital, Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100050</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hong Ma, Professor</last_name>
        <email>mahongmd@aliyun.com</email>
      </contact>
      <contact_backup>
        <last_name>Jialing Zhou, Associate research fellow</last_name>
        <email>zhoujialing11@126.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 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>Hepatitis A</mesh_term>
      <mesh_term>Hepatitis B</mesh_term>
      <mesh_term>Hepatitis B, Chronic</mesh_term>
      <mesh_term>Hepatitis</mesh_term>
      <mesh_term>Hepatitis, Chronic</mesh_term>
    </condition_browse>
    <!-- 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/NCT05991531
  org study id: Serum HBV RNA
  nct id: NCT05991531
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Some patients with low-level viremia (LLV) are also likely to develop hepatocellular
        carcinoma (HCC) or other liver diseases. The relationship between HBV RNA levels and fibrosis
        in patients with HBV DNA negative or LLV is still lacking evidence. The purpose of this study
        is to observe the differences in HBV RNA levels and their association with efficacy in HBV
        DNA negative or LLV patients. Investigators conduct the prospective, single-center,
        non-randomized, observational clinical study. A total of 100 chronic hepatitis B (CHB)
        patients who receive antiviral therapy with nucleoside (acid) analogues for 1-3 years will be
        enrolled. The enrolled patients will be followed up five times to collect clinical data and
        record adverse events (at baseline, week 12, week 24, week 36 and week 48, respectively).
  observational model: Cohort
  time perspective: Prospective
  measure: The decrease of HBV RNA from baseline to 48 weeks
  time frame: 2023.8-2025.8
  description: The investigators detect the dynamic change of HBV RNA and the decline from baseline to 48 weeks;
  measure: HBV RNA undetectable rate at 48 weeks;
  time frame: 2023.8-2025.8
  description: After 48 weeks of treatment after enrollment, the investigators detect the HBV RNA undetectable rate 48 weeks;
  measure: The association of the dynamic changes of serum HBV RNA levels with HBsAg and HBeAg levels;
  time frame: 2023.8-2025.8
  description: During 48 weeks of treatment, the investigators detect the association of the dynamic changes of serum HBV RNA levels with HBsAg and HBeAg levels;
  measure: The association of HBV RNA changes with the liver stiffness;
  time frame: 2023.8-2025.8
  description: During 48 weeks of treatment, the investigators detect the association of HBV RNA changes with the liver stiffness;
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Hong Ma, Profession
  phone: 010-63138747
  email: mahongmd@aliyun.com
  last name: Jialing Zhou, Associate research fellow
  email: zhoujialing11@126.com
  facility: 
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor
  mesh term: Hepatitis A
  mesh term: Hepatitis B
  mesh term: Hepatitis B, Chronic
  mesh term: Hepatitis
  mesh term: Hepatitis, Chronic