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/NCT05962307</url>
    </required_header>
    <id_info>
      <org_study_id>IN-IT-589-6246</org_study_id>
      <nct_id>NCT05962307</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Bulevirtide (BLV) Therapy in HDV Chronic Hepatitis (CHD) in Italy</brief_title>
    <acronym>HEP4Di</acronym>
    <official_title>Efficacy and Safety of Bulevirtide (BLV) Therapy in HDV Chronic Hepatitis (CHD) Patients in Italy: a National Real Life Data Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</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>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Spontaneous, pharmacological observational, no-profit, retrospective, multi-center.&#xD;
  &#xD;
        This study was designed to get a &quot;real-life&quot; snapshot across several Italian Hepatology&#xD;
        centers. All HDV patients are followed up according to EASL 2017 guidelines. This allows&#xD;
        uniformity on the indication for antiviral treatment and management of that antiviral&#xD;
        therapy. No off-label medications are used. All data are retrievable from the patient's&#xD;
        medical record. In addition, clinical and biochemical data from patients at month 0, 1, 2, 4,&#xD;
        6 and 12 of treatment, and otherwise within the study period, will be collected&#xD;
        retrospectively/longitudinally.&#xD;
  &#xD;
        The primary objective of the study is to describe the virological response to BLV in all&#xD;
        patients starting BLV therapy, defined as a &gt;2 Log decline in HDV-RNA or undetectable HDV-RNA&#xD;
        (using the Robogene 2.0 quantitative kit, LLQ &lt;6 IU/ml) at month 12 of therapy.&#xD;
  &#xD;
        All patients with active HDV chronic hepatopathy (quantifiable HDV-RNA) who initiated&#xD;
        treatment with BLV 2 mg/day during the study period at the S.C. Gastroenterology and&#xD;
        Hepatology (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico) and at participating&#xD;
        centers, and who met the inclusion criteria and none of the exclusion criteria.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Actual">May 31, 2023</completion_date>
    <primary_completion_date type="Actual">April 30, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Describe the virological response to BLV in all patients starting BLV therapy</measure>
      <time_frame>Month 12</time_frame>
      <description>percentage of patients with undetectable HDV RNA.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Describe the virological response to BLV in all patients starting BLV therapy</measure>
      <time_frame>Month 12</time_frame>
      <description>percentage of patients with ≥ 2 log IU/ml decline of HDV RNA at month 12 of BLV therapy, compared to baseline.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Evaluation of the percentage of patients with &gt;2 Log decrease in HDV-RNA along with normalization of ALT, at the twelfth month of treatment</measure>
      <time_frame>Month 12</time_frame>
      <description>Percentage of patients with &gt;2 Log decrease in HDV-RNA along with normalization of ALT</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of the percentage of patients with normal ALT, at the twelfth month of treatment</measure>
      <time_frame>Month 12</time_frame>
      <description>Percentage of patients with normal ALT at 12 months of BLV treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of the percentage of patients with clinical response, i.e., the percentage of patients who remain free of liver complications, such as HCC or decompensation, at the end of the first year of treatment</measure>
      <time_frame>Month 12</time_frame>
      <description>Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of treatment safety</measure>
      <time_frame>Month 12</time_frame>
      <description>Occurrence change in serum bile acid levels (µmol/L)</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">50</enrollment>
    <condition>Hepatitis D</condition>
    <arm_group>
      <arm_group_label>Hepatis Delta</arm_group_label>
      <description>Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Bulevirtide</intervention_name>
      <description>dose of 2 mg/day subcutaneously</description>
      <arm_group_label>Hepatis Delta</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All patients with active HDV chronic hepatopathy (quantifiable HDV-RNA) who initiated&#xD;
          treatment with BLV 2 mg/day during the study period at the S.C. Gastroenterology and&#xD;
          Hepatology (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico) and at participating&#xD;
          centers, and who met the inclusion criteria and none of the exclusion criteria.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years of age or older&#xD;
  &#xD;
            -  Chronic hepatitis delta&#xD;
  &#xD;
            -  Compensated cirrhosis HDV related&#xD;
  &#xD;
            -  Bulevertide 2 mg/day within December 15, 2020, to December 31, 2022&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - HDV-related decompensated cirrhosis (CPT ≥7)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.</name>
        <address>
          <city>Milan</city>
          <state>MI</state>
          <zip>20122</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>March 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 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 D</mesh_term>
      <mesh_term>Hepatitis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT05962307
  org study id: IN-IT-589-6246
  nct id: NCT05962307
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: Yes
  Spontaneous, pharmacological observational, no-profit, retrospective, multi-center.
  
        This study was designed to get a "real-life" snapshot across several Italian Hepatology
        centers. All HDV patients are followed up according to EASL 2017 guidelines. This allows
        uniformity on the indication for antiviral treatment and management of that antiviral
        therapy. No off-label medications are used. All data are retrievable from the patient's
        medical record. In addition, clinical and biochemical data from patients at month 0, 1, 2, 4,
        6 and 12 of treatment, and otherwise within the study period, will be collected
        retrospectively/longitudinally.
  
        The primary objective of the study is to describe the virological response to BLV in all
        patients starting BLV therapy, defined as a >2 Log decline in HDV-RNA or undetectable HDV-RNA
        (using the Robogene 2.0 quantitative kit, LLQ <6 IU/ml) at month 12 of therapy.
  
        All patients with active HDV chronic hepatopathy (quantifiable HDV-RNA) who initiated
        treatment with BLV 2 mg/day during the study period at the S.C. Gastroenterology and
        Hepatology (Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico) and at participating
        centers, and who met the inclusion criteria and none of the exclusion criteria.
  observational model: Cohort
  time perspective: Retrospective
  measure: Describe the virological response to BLV in all patients starting BLV therapy
  time frame: Month 12
  description: percentage of patients with undetectable HDV RNA.
  measure: Describe the virological response to BLV in all patients starting BLV therapy
  time frame: Month 12
  description: percentage of patients with ≥ 2 log IU/ml decline of HDV RNA at month 12 of BLV therapy, compared to baseline.
  measure: Evaluation of the percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT, at the twelfth month of treatment
  time frame: Month 12
  description: Percentage of patients with >2 Log decrease in HDV-RNA along with normalization of ALT
  measure: Evaluation of the percentage of patients with normal ALT, at the twelfth month of treatment
  time frame: Month 12
  description: Percentage of patients with normal ALT at 12 months of BLV treatment
  measure: Evaluation of the percentage of patients with clinical response, i.e., the percentage of patients who remain free of liver complications, such as HCC or decompensation, at the end of the first year of treatment
  time frame: Month 12
  description: Percentage of patients who remain free of liver complications (de novo HCC or onset of decompensation)
  measure: Evaluation of treatment safety
  time frame: Month 12
  description: Occurrence change in serum bile acid levels (µmol/L)
  arm group label: Hepatis Delta
  description: Bulevirtide (BLV) at a dose of 2 mg/day subcutaneously
  intervention type: Drug
  intervention name: Bulevirtide
  description: dose of 2 mg/day subcutaneously
  arm group label: Hepatis Delta
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Italy
  responsible party type: Sponsor
  mesh term: Hepatitis A
  mesh term: Hepatitis D
  mesh term: Hepatitis
  sharing ipd: Undecided