<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/NCT03294798</url>
  </required_header>
  <id_info>
    <org_study_id>9216-Ib</org_study_id>
    <nct_id>NCT03294798</nct_id>
  </id_info>
  <brief_title>Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitis B Patient</brief_title>
  <official_title>Evaluate the Pharmacokinetic and Pharmacodynamic Profile, Safety, and Tolerability of Escalating Single Dose &amp; Multiple Dose by Using Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Hepatitits B Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tianjin SinoBiotech Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tianjin SinoBiotech 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the dosages of recombinant human serum&#xD;
      albumin/interferon alpha2b fusion protein injection on HBV subjects. The secondary purposes&#xD;
      is to get the PK/PD data in recombinant human serum albumin/interferon alpha2b fusion protein&#xD;
      injection on HBV subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open-label study that will be conducted at three sites in China to characterize&#xD;
      the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon&#xD;
      alpha2b Fusion Protein in HBV subjects. Subjects will receive a single dose of Recombinant&#xD;
      Human Serum Albumin/interferon alpha2b Fusion Protein or active comparator Pegasys at Day 0.&#xD;
      A multipule-dose administration in HBV subjects will last 12 weeks after four weeks washout&#xD;
      period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 13, 2017</start_date>
  <completion_date type="Actual">March 15, 2021</completion_date>
  <primary_completion_date type="Actual">March 15, 2019</primary_completion_date>
  <phase>Phase 1/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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the rates of subjects with the level of HBVDNA≤0 IU/mL after treatment</measure>
    <time_frame>17 weeks</time_frame>
    <description>HBV DNA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the rates of HBV DNA level decrease by more than 2log10 at the end of 4 weeks and after treatment</measure>
    <time_frame>4 weeks and 17 weeks</time_frame>
    <description>HBV DNA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the recovery rates of ALT after treatment</measure>
    <time_frame>17 weeks</time_frame>
    <description>ALT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the negative conversion rates of HBsAg/HBeAg and HBeAg seroconversion rates after treatment</measure>
    <time_frame>17 weeks</time_frame>
    <description>HBsAg/HBeAg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the rates of HBsAg decrease from baseline after treatment</measure>
    <time_frame>17 weeks</time_frame>
    <description>HBsAg</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Hepatitis B Virus</condition>
  <arm_group>
    <arm_group_label>Human Serum Albumin/interferon alpha2b</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Human Serum Albumin/interferon alpha2b fusion protein 600-900μg,once per two weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pegasys</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pegasys 180 mcg, once per week</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Human Serum Albumin/interferon alpha2b fusion protein</intervention_name>
    <description>In experiemental groups, each subject will recieve 600,750,900mg once per two weeks during multiple dose period.</description>
    <arm_group_label>Human Serum Albumin/interferon alpha2b</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Pegasys</intervention_name>
    <description>In comparator group, each subject will recieve 180mcg once per week.</description>
    <arm_group_label>Pegasys</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HBV patients who have positive HBeAg or HBeAb&#xD;
&#xD;
          -  Must be healthy males or females between 18 to 60 years old&#xD;
&#xD;
          -  Must have a body mass index (BMI) of 18 to 30 kg/m2&#xD;
&#xD;
          -  HBV DNA≥2000 IU/mL&#xD;
&#xD;
          -  ALT≥1.3 ULN and ≤10 ULN&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Administrated a nucleoside analogues (acid) or interferons against hepatitis B virus&#xD;
             drugs, immunosuppressants, immune regulator before 6 months;Or any other against&#xD;
             hepatitis b virus therapy at the same time.&#xD;
&#xD;
          -  Participated in other clinical trials within a month.&#xD;
&#xD;
          -  Allergic to interferon.&#xD;
&#xD;
          -  T-Bil ≥2 ULN. ALB&lt;35g/L. PT≥4s.&#xD;
&#xD;
          -  Positive HCV-Ab,HEV-Ab,EBV-Ab,CMV-Ab,TPPA,HIV-Ab.&#xD;
&#xD;
          -  Organ transplant patients, except cornea or hair transplantation.&#xD;
&#xD;
          -  Other hepatopathy exclude NAFLD .&#xD;
&#xD;
          -  Drug addiction or alcohol dependence.&#xD;
&#xD;
          -  Malignancy(except cured cervical carcinoma in situ, BCC, squamous cell carcinoma)&#xD;
             except liver history.&#xD;
&#xD;
          -  Serious retinal disease.&#xD;
&#xD;
          -  Active hemorrhagic disease or severe hematopoietic dysfunction or blood coagulation&#xD;
             disorder.&#xD;
&#xD;
          -  Autoimmune disease.&#xD;
&#xD;
          -  Uncontrolled diabetes or thyroid disease or beyond grade 2 blood pressure.&#xD;
&#xD;
          -  WBC&lt;3×109/L or ANC&lt;1.5 ×109/L or PLT&lt;90 ×109/L or HGB&lt;ULN.&#xD;
&#xD;
          -  HCC or AFP&gt;100ng/mL.&#xD;
&#xD;
          -  Chronic kidney disease or sCr&gt;ULN.&#xD;
&#xD;
          -  Lactating women or pregnancy.&#xD;
&#xD;
          -  Cardiovascular and cerebrovascular events within 6 months.&#xD;
&#xD;
          -  Neurological or psychiatric disease or family history.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>meixia wang, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing YouAn Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>jun li, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital with Nanjing Medical University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>liang chen, professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Public Health Clinical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beijing YouAn Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100069</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>March 29, 2021</last_update_submitted>
  <last_update_submitted_qc>March 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2021</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</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Interferons</mesh_term>
    <mesh_term>Interferon-alpha</mesh_term>
    <mesh_term>Interferon alpha-2</mesh_term>
    <mesh_term>Peginterferon alfa-2a</mesh_term>
  </intervention_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/NCT03294798
org study id: 9216-Ib
nct id: NCT03294798
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to evaluate the dosages of recombinant human serum
      albumin/interferon alpha2b fusion protein injection on HBV subjects. The secondary purposes
      is to get the PK/PD data in recombinant human serum albumin/interferon alpha2b fusion protein
      injection on HBV subjects.
This is an open-label study that will be conducted at three sites in China to characterize
      the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon
      alpha2b Fusion Protein in HBV subjects. Subjects will receive a single dose of Recombinant
      Human Serum Albumin/interferon alpha2b Fusion Protein or active comparator Pegasys at Day 0.
      A multipule-dose administration in HBV subjects will last 12 weeks after four weeks washout
      period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: the rates of subjects with the level of HBVDNA≤0 IU/mL after treatment
time frame: 17 weeks
description: HBV DNA
measure: the rates of HBV DNA level decrease by more than 2log10 at the end of 4 weeks and after treatment
time frame: 4 weeks and 17 weeks
description: HBV DNA
measure: the recovery rates of ALT after treatment
time frame: 17 weeks
description: ALT
measure: the negative conversion rates of HBsAg/HBeAg and HBeAg seroconversion rates after treatment
time frame: 17 weeks
description: HBsAg/HBeAg
measure: the rates of HBsAg decrease from baseline after treatment
time frame: 17 weeks
description: HBsAg
arm group label: Human Serum Albumin/interferon alpha2b
arm group type: Experimental
description: Human Serum Albumin/interferon alpha2b fusion protein 600-900μg,once per two weeks.
arm group label: Pegasys
arm group type: Active Comparator
description: Pegasys 180 mcg, once per week
intervention type: Biological
intervention name: Human Serum Albumin/interferon alpha2b fusion protein
description: In experiemental groups, each subject will recieve 600,750,900mg once per two weeks during multiple dose period.
arm group label: Human Serum Albumin/interferon alpha2b
intervention type: Biological
intervention name: Pegasys
description: In comparator group, each subject will recieve 180mcg once per week.
arm group label: Pegasys
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: meixia wang, professor
role: Principal Investigator
affiliation: Beijing YouAn Hospital
last name: jun li, professor
role: Principal Investigator
affiliation: The First Affiliated Hospital with Nanjing Medical University
last name: liang chen, professor
role: Principal Investigator
affiliation: Shanghai Public Health Clinical Center
facility: 
country: China
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis
mesh term: Interferons
mesh term: Interferon-alpha
mesh term: Interferon alpha-2
mesh term: Peginterferon alfa-2a