<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/NCT02992704</url>
  </required_header>
  <id_info>
    <org_study_id>2014/00205</org_study_id>
    <nct_id>NCT02992704</nct_id>
  </id_info>
  <brief_title>Peg-interferon for Inactive Chronic Hepatitis B Carriers</brief_title>
  <acronym>INACTIVE</acronym>
  <official_title>Randomised Control Study for Inactive Chronic Hepatitis B Patients With Low Viral Load, With Peg-Interferon (INACTIVE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seng Gee Lim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roche Pharma AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>National University Health System, Singapore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic Hepatitis B carriers (normal LFTs and viral load &lt; 2 x 10^4 IU/ml are not recommended&#xD;
      to be treated by guidelines as they are at low risk for complications. However, it is unclear&#xD;
      if treatment can enhance HBsAg loss which has been shown to be associated with significantly&#xD;
      lower risk of complications compared to those without HBsAg loss. Consequently, this is a&#xD;
      proof of concept study to determine the possibility of HBsAg loss in Chronic Hepatitis B&#xD;
      carriers in a randomised open label clinical trial comparing no treatment to 24 weeks&#xD;
      peg-interferon alpha 2a or 48 weeks peginterferon alpha 2a (randomised 1:1:1). The primary&#xD;
      endpoint of HBsAg loss will be evaluated 24 weeks after the end of therapy for those on&#xD;
      therapy and matched to an equivalent timepoint in the control arm. The sample size&#xD;
      calculation is 30 patients in each arm for a 20% difference between any experimental arm and&#xD;
      the control arm.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Hypothesis: Chronic hepatitis B carriers (defined as HBeAg negative hepatitis B patients&#xD;
      with HBV DNA &lt;2x104 IU/mL, absence of cirrhosis and normal ALT) may experience higher rates&#xD;
      of HBsAg seroclearance with pegylated interferon therapy.&#xD;
&#xD;
      2A. Primary Objective&#xD;
&#xD;
        -  The proportion of subjects with HBsAg loss at Week 24 of followup after treatment with&#xD;
           24 or 48 weeks of pegylated interferon alpha 2a compared to no therapy.&#xD;
&#xD;
           2B. Secondary Objective&#xD;
&#xD;
        -  The proportion of subjects who experience HBsAg loss with 24 versus 48 weeks of&#xD;
           pegylated interferon at the end of treatment, and at end of followup.&#xD;
&#xD;
        -  The rate of quantitative HBsAg decline in relation to HBsAg loss&#xD;
&#xD;
        -  The proportion of subjects with virological response (HBV DNA level &lt;13.5IU/mL) at Weeks&#xD;
           12 and 24 of treatment, and week 24 of followup.&#xD;
&#xD;
           2C Study population: 90 patient will be enrolled.&#xD;
&#xD;
      3.1 Inclusion Criteria&#xD;
&#xD;
      For entry into this study, the following inclusion criteria must be met:&#xD;
&#xD;
        -  Males or females age 21-75 years old (inclusive)&#xD;
&#xD;
        -  Treatment naïve&#xD;
&#xD;
        -  Documented HBsAg or HBV DNA positive for ≥ 6 months.&#xD;
&#xD;
        -  Documented HBeAg negative and anti-HBe positive&#xD;
&#xD;
        -  ALT ≤1xULN&#xD;
&#xD;
        -  quantitative HBsAg &lt;1,000 IU/ml OR HBV DNA &lt;2x104 IU/mL at screening&#xD;
&#xD;
        -  Absence of cirrhosis documented by liver biopsy or transient elastography within 6&#xD;
           months (Fibroscan®; Fibrosis stage &gt;2 (score ≥ 10Kpa) will not be eligible for this&#xD;
           study.)&#xD;
&#xD;
        -  Patient has agreed not to take any other investigational drug or systemic anti-viral,&#xD;
           cytotoxic, corticosteroid, immunomodulatory agents or Chinese traditional remedies&#xD;
           unless clinically indicated.&#xD;
&#xD;
        -  Patient is able to give written consent prior to study start and to comply with the&#xD;
           study requirements.&#xD;
&#xD;
        -  Women of childbearing age must have a negative urine (ß-HCG) pregnancy test taken within&#xD;
           14 days of starting therapy&#xD;
&#xD;
      3.2 Exclusion Criteria&#xD;
&#xD;
      For entry into this study, the following exclusion criteria must not be met:&#xD;
&#xD;
        -  Patients who are currently on treatment with nucleoside/nucleotide analogues or have&#xD;
           been treated for Hepatitis B in the past&#xD;
&#xD;
        -  Presence of cirrhosis documented by liver biopsy or transient elastography (score ≥&#xD;
           10kpa)&#xD;
&#xD;
        -  Active Co-infection with HIV antibody, HCV antibody or HDV antibody positivity.&#xD;
&#xD;
        -  Evidence of decompensated liver disease defined as a direct (conjugated) bilirubin &gt;1.2x&#xD;
           upper limit of normal (ULN), prothrombin time (PT) &gt;1.5xULN , serum bilirubin &lt;35g/L, or&#xD;
           prior history of clinical hepatic decompensation as illustrated by presence of (eg.&#xD;
           ascites, encephalopathy, variceal haemorrhage)&#xD;
&#xD;
        -  Evidence of hepatocellular carcinoma&#xD;
&#xD;
        -  Absolute neutrophil count &lt;1.5x10^9/L or Hemoglobin &lt;12 g/L for men or &lt;11 g/L for&#xD;
           women, or platelet count &lt; 90x10^9/L&#xD;
&#xD;
        -  History of depression or psychiatric disease&#xD;
&#xD;
        -  Uncontrolled thyroid disease defined as thyroid-stimulating hormone (TSH) &gt;1.2 ULN or&#xD;
           0.8xLLN or thyroid dysfunction&#xD;
&#xD;
        -  Any immunomodulators, systemic cytotoxic agents, or systemic cortiosteriods within 6&#xD;
           months before trial entry&#xD;
&#xD;
        -  Significant renal, cardiovascular, pulmonary, neurological, autoimmune disease or bone&#xD;
           disease (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta,&#xD;
           osteochrondroses, multiple bone fractures)&#xD;
&#xD;
        -  Malignant disease within 5 years of trial entry&#xD;
&#xD;
        -  Women who are pregnant and who are not practicing adequate birth control measures,&#xD;
           (defined as two methods of birth control with at least one barrier method) or who are&#xD;
           lactating.&#xD;
&#xD;
      4.1 Study Treatment&#xD;
&#xD;
      Product, Dose, and Mode of Administration:&#xD;
&#xD;
      Peginterferon α-2a (PEG), 180mcg, will be administered weekly by subcutaneous injection for&#xD;
      the specified period of time (see Study Design, Arms B and C). Pegasys® (Roche&#xD;
      Pharmaceuticals).&#xD;
&#xD;
      Reference Therapy, Dose, and Mode of Administration:&#xD;
&#xD;
      Peginterferon α-2a (PEG), 180mcg subcutaneous injection once weekly&#xD;
&#xD;
      4.2 Overview The study will be conducted as a computer randomised clinical trial with&#xD;
      concealment of allocation. Patients fulfilling inclusion and exclusion criteria will be&#xD;
      randomised after completing screening. Patients will be randomly allocated to three parallel&#xD;
      arms: no therapy, 24 weeks peg-interferon alpha 2a, and 48 weeks interferon alpha 2a.&#xD;
      Patients will be monitored 4 weekly initial then 12 weekly till end of therapy, then for an&#xD;
      additional 24 weeks after completing therapy. Patients on no therapy will be monitored for 72&#xD;
      weeks.&#xD;
&#xD;
      4.3 Endpoints/efficacy assessements Primary: HBsAg loss at end of followup for interferon&#xD;
      arms compared to no therapy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Anticipated">August 2019</completion_date>
  <primary_completion_date type="Anticipated">August 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Three arm, parallel open label study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>HBsAg loss</measure>
    <time_frame>24 weeks after end of therapy</time_frame>
    <description>Qualitative HBsAg assay reads &quot;non-detectable&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>HBsAg loss</measure>
    <time_frame>At the end of 24 and 48 weeks of peginterferon therapy</time_frame>
    <description>Qualitative HBsAg assay reads &quot;non-detectable&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decline in quantitative HBsAg level</measure>
    <time_frame>At week 24, 48 and 24 weeks after completion of therapy</time_frame>
    <description>Based on quantitative HBsAg assay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proportion of patients with undetectable HBV DNA</measure>
    <time_frame>At week 24, 48 of therapy, and 24 weeks after end of therapy</time_frame>
    <description>HBV DNA assay&lt;13.5 IU/ml</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Chronic Hepatitis, B Virus</condition>
  <condition>Carrier of Viral Hepatitis Type B</condition>
  <arm_group>
    <arm_group_label>PEG 24 weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>peginterferon alpha 2a 180mcg for 24 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PEG 48 weeks</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>peginterferon alpha 2a 180mcg 48 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No treatment for 72 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Peginterferon Alfa-2A</intervention_name>
    <description>peginterferon alpha 2a 180mcg weekly for either 24 or 48 weeks</description>
    <arm_group_label>PEG 24 weeks</arm_group_label>
    <arm_group_label>PEG 48 weeks</arm_group_label>
    <other_name>pegasys</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Treatment naïve&#xD;
&#xD;
          -  Documented HBsAg or HBV DNA positive for ≥ 6 months.&#xD;
&#xD;
          -  Documented HBeAg negative and anti-HBe positive&#xD;
&#xD;
          -  ALT ≤1xULN&#xD;
&#xD;
          -  quantitative HBsAg &lt;1,000 IU/ml&#xD;
&#xD;
          -  HBV DNA &lt;2x104 IU/mL at screening&#xD;
&#xD;
          -  Absence of cirrhosis documented by liver biopsy or transient elastography within 6&#xD;
             months (Fibroscan®; Fibrosis stage &gt;2 (score ≥ 10Kpa) will not be eligible for this&#xD;
             study.)&#xD;
&#xD;
          -  Patient has agreed not to take any other investigational drug or systemic anti-viral,&#xD;
             cytotoxic, corticosteroid, immunomodulatory agents or Chinese traditional remedies&#xD;
             unless clinically indicated.&#xD;
&#xD;
          -  Patient is able to give written consent prior to study start and to comply with the&#xD;
             study requirements.&#xD;
&#xD;
          -  Women of childbearing age must have a negative urine (ß-HCG) pregnancy test taken&#xD;
             within 14 days of starting therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are currently on treatment with nucleoside/nucleotide analogues or have&#xD;
             been treated for Hepatitis B in the past&#xD;
&#xD;
          -  Presence of cirrhosis documented by liver biopsy or transient elastography (score ≥&#xD;
             10kpa)&#xD;
&#xD;
          -  Active Co-infection with HIV antibody, HCV antibody or HDV antibody positivity.&#xD;
&#xD;
          -  Evidence of decompensated liver disease defined as a direct (conjugated) bilirubin&#xD;
             &gt;1.2x upper limit of normal (ULN), prothrombin time (PT) &gt;1.5xULN , serum bilirubin&#xD;
             &lt;35g/L, or prior history of clinical hepatic decompensation as illustrated by presence&#xD;
             of (eg. ascites, encephalopathy, variceal haemorrhage)&#xD;
&#xD;
          -  Evidence of hepatocellular carcinoma&#xD;
&#xD;
          -  Absolute neutrophil count &lt;1.5x10^9/L or Hemoglobin &lt;12 g/L for men or &lt;11 g/L for&#xD;
             women, or platelet count &lt; 90x10^9/L&#xD;
&#xD;
          -  History of depression or psychiatric disease&#xD;
&#xD;
          -  Uncontrolled thyroid disease defined as thyroid-stimulating hormone (TSH) &gt;1.2 ULN or&#xD;
             0.8xLLN or thyroid dysfunction&#xD;
&#xD;
          -  Any immunomodulators, systemic cytotoxic agents, or systemic cortiosteriods within 6&#xD;
             months before trial entry&#xD;
&#xD;
          -  Significant renal, cardiovascular, pulmonary, neurological, autoimmune disease or bone&#xD;
             disease (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta,&#xD;
             osteochrondroses, multiple bone fractures)&#xD;
&#xD;
          -  Malignant disease within 5 years of trial entry&#xD;
&#xD;
          -  Women who are pregnant and who are not practicing adequate birth control measures,&#xD;
             (defined as two methods of birth control with at least one barrier method) or who are&#xD;
             lactating.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seng Gee Lim, MBBS, FRACP, FRCP, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University Health System</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National University Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>119228</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>March 17, 2019</last_update_submitted>
  <last_update_submitted_qc>March 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>National University Health System, Singapore</investigator_affiliation>
    <investigator_full_name>Seng Gee Lim</investigator_full_name>
    <investigator_title>Director of Hepatology</investigator_title>
  </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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peginterferon alfa-2a</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/NCT02992704
org study id: 2014/00205
nct id: NCT02992704
lead sponsor: 
collaborator: 
has dmc: No
Chronic Hepatitis B carriers (normal LFTs and viral load < 2 x 10^4 IU/ml are not recommended
      to be treated by guidelines as they are at low risk for complications. However, it is unclear
      if treatment can enhance HBsAg loss which has been shown to be associated with significantly
      lower risk of complications compared to those without HBsAg loss. Consequently, this is a
      proof of concept study to determine the possibility of HBsAg loss in Chronic Hepatitis B
      carriers in a randomised open label clinical trial comparing no treatment to 24 weeks
      peg-interferon alpha 2a or 48 weeks peginterferon alpha 2a (randomised 1:1:1). The primary
      endpoint of HBsAg loss will be evaluated 24 weeks after the end of therapy for those on
      therapy and matched to an equivalent timepoint in the control arm. The sample size
      calculation is 30 patients in each arm for a 20% difference between any experimental arm and
      the control arm.
1. Hypothesis: Chronic hepatitis B carriers (defined as HBeAg negative hepatitis B patients
      with HBV DNA <2x104 IU/mL, absence of cirrhosis and normal ALT) may experience higher rates
      of HBsAg seroclearance with pegylated interferon therapy.

      2A. Primary Objective

        -  The proportion of subjects with HBsAg loss at Week 24 of followup after treatment with
           24 or 48 weeks of pegylated interferon alpha 2a compared to no therapy.

           2B. Secondary Objective

        -  The proportion of subjects who experience HBsAg loss with 24 versus 48 weeks of
           pegylated interferon at the end of treatment, and at end of followup.

        -  The rate of quantitative HBsAg decline in relation to HBsAg loss

        -  The proportion of subjects with virological response (HBV DNA level <13.5IU/mL) at Weeks
           12 and 24 of treatment, and week 24 of followup.

           2C Study population: 90 patient will be enrolled.

      3.1 Inclusion Criteria

      For entry into this study, the following inclusion criteria must be met:

        -  Males or females age 21-75 years old (inclusive)

        -  Treatment naïve

        -  Documented HBsAg or HBV DNA positive for ≥ 6 months.

        -  Documented HBeAg negative and anti-HBe positive

        -  ALT ≤1xULN

        -  quantitative HBsAg <1,000 IU/ml OR HBV DNA <2x104 IU/mL at screening

        -  Absence of cirrhosis documented by liver biopsy or transient elastography within 6
           months (Fibroscan®; Fibrosis stage >2 (score ≥ 10Kpa) will not be eligible for this
           study.)

        -  Patient has agreed not to take any other investigational drug or systemic anti-viral,
           cytotoxic, corticosteroid, immunomodulatory agents or Chinese traditional remedies
           unless clinically indicated.

        -  Patient is able to give written consent prior to study start and to comply with the
           study requirements.

        -  Women of childbearing age must have a negative urine (ß-HCG) pregnancy test taken within
           14 days of starting therapy

      3.2 Exclusion Criteria

      For entry into this study, the following exclusion criteria must not be met:

        -  Patients who are currently on treatment with nucleoside/nucleotide analogues or have
           been treated for Hepatitis B in the past

        -  Presence of cirrhosis documented by liver biopsy or transient elastography (score ≥
           10kpa)

        -  Active Co-infection with HIV antibody, HCV antibody or HDV antibody positivity.

        -  Evidence of decompensated liver disease defined as a direct (conjugated) bilirubin >1.2x
           upper limit of normal (ULN), prothrombin time (PT) >1.5xULN , serum bilirubin <35g/L, or
           prior history of clinical hepatic decompensation as illustrated by presence of (eg.
           ascites, encephalopathy, variceal haemorrhage)

        -  Evidence of hepatocellular carcinoma

        -  Absolute neutrophil count <1.5x10^9/L or Hemoglobin <12 g/L for men or <11 g/L for
           women, or platelet count < 90x10^9/L

        -  History of depression or psychiatric disease

        -  Uncontrolled thyroid disease defined as thyroid-stimulating hormone (TSH) >1.2 ULN or
           0.8xLLN or thyroid dysfunction

        -  Any immunomodulators, systemic cytotoxic agents, or systemic cortiosteriods within 6
           months before trial entry

        -  Significant renal, cardiovascular, pulmonary, neurological, autoimmune disease or bone
           disease (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta,
           osteochrondroses, multiple bone fractures)

        -  Malignant disease within 5 years of trial entry

        -  Women who are pregnant and who are not practicing adequate birth control measures,
           (defined as two methods of birth control with at least one barrier method) or who are
           lactating.

      4.1 Study Treatment

      Product, Dose, and Mode of Administration:

      Peginterferon α-2a (PEG), 180mcg, will be administered weekly by subcutaneous injection for
      the specified period of time (see Study Design, Arms B and C). Pegasys® (Roche
      Pharmaceuticals).

      Reference Therapy, Dose, and Mode of Administration:

      Peginterferon α-2a (PEG), 180mcg subcutaneous injection once weekly

      4.2 Overview The study will be conducted as a computer randomised clinical trial with
      concealment of allocation. Patients fulfilling inclusion and exclusion criteria will be
      randomised after completing screening. Patients will be randomly allocated to three parallel
      arms: no therapy, 24 weeks peg-interferon alpha 2a, and 48 weeks interferon alpha 2a.
      Patients will be monitored 4 weekly initial then 12 weekly till end of therapy, then for an
      additional 24 weeks after completing therapy. Patients on no therapy will be monitored for 72
      weeks.

      4.3 Endpoints/efficacy assessements Primary: HBsAg loss at end of followup for interferon
      arms compared to no therapy
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Three arm, parallel open label study
primary purpose: Treatment
masking: None (Open Label)
measure: HBsAg loss
time frame: 24 weeks after end of therapy
description: Qualitative HBsAg assay reads "non-detectable"
measure: HBsAg loss
time frame: At the end of 24 and 48 weeks of peginterferon therapy
description: Qualitative HBsAg assay reads "non-detectable"
measure: Decline in quantitative HBsAg level
time frame: At week 24, 48 and 24 weeks after completion of therapy
description: Based on quantitative HBsAg assay
measure: proportion of patients with undetectable HBV DNA
time frame: At week 24, 48 of therapy, and 24 weeks after end of therapy
description: HBV DNA assay<13.5 IU/ml
arm group label: PEG 24 weeks
arm group type: Experimental
description: peginterferon alpha 2a 180mcg for 24 weeks
arm group label: PEG 48 weeks
arm group type: Experimental
description: peginterferon alpha 2a 180mcg 48 weeks
arm group label: Control
arm group type: No Intervention
description: No treatment for 72 weeks
intervention type: Drug
intervention name: Peginterferon Alfa-2A
description: peginterferon alpha 2a 180mcg weekly for either 24 or 48 weeks
arm group label: PEG 24 weeks
arm group label: PEG 48 weeks
other name: pegasys
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
last name: Seng Gee Lim, MBBS, FRACP, FRCP, MD
role: Principal Investigator
affiliation: National University Health System
facility: 
country: Singapore
responsible party type: Sponsor-Investigator
investigator affiliation: National University Health System, Singapore
investigator full name: Seng Gee Lim
investigator title: Director of Hepatology
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Peginterferon alfa-2a
sharing ipd: No