<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/NCT03013556</url>
  </required_header>
  <id_info>
    <org_study_id>SHDC12016101</org_study_id>
    <nct_id>NCT03013556</nct_id>
  </id_info>
  <brief_title>Study on an Optimal Antiviral Treatment in HBeAg Positive Chronic Hepatitis B Patients</brief_title>
  <official_title>A Prospective, Randomized, Multicenter, Open-label Study of Optimal Antiviral Treatment in HBeAg Positive Chronic Hepatitis B Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ruijin Hospital</source>
  <brief_summary>
    <textblock>
      The current study is a prospective, randomized, open, multi-center investigation. The aim of&#xD;
      the study is to investigate whether the HBeAg seroconversion rate can be improved if applying&#xD;
      combination therapy in HBeAg positive CHB patients who has achieved&#xD;
      HBVDNA&lt;105copies/ml，HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The HBeAg positive chronic hepatitis B(CHB) subjects who has achieved HBV&#xD;
      DNA&lt;10*5copies/ml，HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2 will be randomized to&#xD;
      three groups. The subjects who go into group A will be treated by tenofovir disoproxil&#xD;
      fumarate (TDF) for 96 weeks; The subjects who go into group B will be treated by TDF in the&#xD;
      first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for&#xD;
      another 48 weeks; The subjects who go into group C will be treated by the combination of TDF&#xD;
      and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48&#xD;
      weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2021</primary_completion_date>
  <phase>Phase 4</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>Number of subjects who achieve HBeAg seroconversion</measure>
    <time_frame>at 96 week</time_frame>
    <description>The number of subjects with HBeAg seroconversion at week 96 will be measured</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants who achieve HBeAg seroconversion</measure>
    <time_frame>at 48 week;at 72 week</time_frame>
    <description>The number of subjects with HBeAg seroconversion at week 48 and 72 will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The percentage decrease of HBsAg level at group A,B,C</measure>
    <time_frame>at 48 week;at 72 week;at 96 week</time_frame>
    <description>The level of HBsAg in group A,B,C at week 48 ,72 and 96 will be measured,changing from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants who achieve HBeAg loss</measure>
    <time_frame>at 48 week;at 72 week;at 96 week</time_frame>
    <description>The number of subjects with HBeAg loss at week48.72 and 96 will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of subjects who achieve HBVDNA undetectable</measure>
    <time_frame>at 24 week;48 week;at 72 week;at 96 week</time_frame>
    <description>The number of subjects with HBVDNA undetectable at week 24,48,72 and 96 will be measured</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The factor such as HBsAg level related to responsible rate</measure>
    <time_frame>at week 48,72,96</time_frame>
    <description>The HBsAg level at week 48,72,96 will be measured, to assess whether the quantitative HBsAg level related to the responsible rate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of subjects who achieve ALT back to normal</measure>
    <time_frame>at 48 week;at 72 week;at 96 week</time_frame>
    <description>The number of subjects with normal ALT at week 48,72 and 96 will be measured</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Chronic Hepatitis</condition>
  <arm_group>
    <arm_group_label>Group A,TDF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The subjects in group A will be treated by TDF for 96 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B,TDF+PEG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects in group B will be treated by TDF in the first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for another 48 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C,TDF+PEG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects in group C will be treated by the combination of TDF and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Group A, TDF</intervention_name>
    <description>TDF for 96 weeks</description>
    <arm_group_label>Group A,TDF</arm_group_label>
    <other_name>tenofovir</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Group B:TDF then TDF and Peginterferon alfa-2a</intervention_name>
    <description>Subjects will be treated by TDF in the first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for another 48 weeks</description>
    <arm_group_label>Group B,TDF+PEG</arm_group_label>
    <other_name>tenofovir,pegasys</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Group C:TDF and Peginterferon alfa-2a then TDF</intervention_name>
    <description>Subjects will be treated by the combination of TDF and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48 weeks.</description>
    <arm_group_label>Group C,TDF+PEG</arm_group_label>
    <other_name>tenofovir,pegasys</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female patients with age ≥18 and ≤65 years;&#xD;
&#xD;
          2. There should be evidences that HBsAg and HBeAg have been positive for more than 6&#xD;
             months with HBsAb and HBeAb negative;HBsAg≤50000IU/ml, ALT≥ 2ULN,Liver histology above&#xD;
             G2S2 and HBV DNA≥10*5 copies/mL;&#xD;
&#xD;
          3. Women without ongoing pregnancy or breast feeding and both women and men willing to&#xD;
             take an effective contraceptive measure during the treatment;&#xD;
&#xD;
          4. Agree to participate in the study and sign the patient informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Treated by immunosuppressant,immunomodulator,Systemic cytotoxic drug,herbs or HBIg&#xD;
             within 6 months prior to the first dose of treatment;&#xD;
&#xD;
          2. ALT≥10 X ULN or total bilirubin ≥2 X ULN;&#xD;
&#xD;
          3. Allergic history to interferon;&#xD;
&#xD;
          4. Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human&#xD;
             immunodeficiency virus (HIV);&#xD;
&#xD;
          5. Child-Pugh scores &gt;7;&#xD;
&#xD;
          6. History or other evidence of a medical condition associated with chronic liver disease&#xD;
             other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic&#xD;
             liver disease, alcoholic liver disease, toxin exposures, thalassemia);&#xD;
&#xD;
          7. Pregnant or breast-feeding Women;&#xD;
&#xD;
          8. Consuming alcohol in excess of 20g/day for women and 30g/day for men within 6 months&#xD;
             prior to enrollment or drug taking history;&#xD;
&#xD;
          9. ANC(absolute neutrophil count)&lt;1.5x 10^9/L or PLT(platelet count)&lt;90x 10^9/L&#xD;
&#xD;
         10. Creatinine over upper limit of normal;&#xD;
&#xD;
         11. History of severe psychiatric disease, especially depression. Severe psychiatric&#xD;
             disease is defined as major depression or psychosis that treated with antidepressant&#xD;
             medication or a major tranquilizer at therapeutic doses respectively at any time prior&#xD;
             to 3 months or any history of the following: a suicidal attempt hospitalization for&#xD;
             psychiatric disease, or a period of disability due to a psychiatric disease;&#xD;
&#xD;
         12. History of immunologically mediated disease, (e.g., inflammatory bowel disease,&#xD;
             idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia,&#xD;
             scleroderma, rheumatoid arthritis etc.);&#xD;
&#xD;
         13. History of esophageal varices bleeding or other evidence of esophageal varices&#xD;
             bleeding or other symptoms consistent with decompensated liver disease;&#xD;
&#xD;
         14. History of severe cardiac disease (e.g., New York Heart Association Functional Class&#xD;
             III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmias&#xD;
             requiring ongoing treatment, unstable angina or other significant cardiovascular&#xD;
             diseases);&#xD;
&#xD;
         15. Hemodialysis patients or patients with renal insufficiency;&#xD;
&#xD;
         16. History of a severe seizure disorder or current anticonvulsant use;&#xD;
&#xD;
         17. Major organ transplantation or other evidence of severe illness, malignancy, or any&#xD;
             other conditions, which would make the patient, in the opinion of the investigator,&#xD;
             unsuitable for the study;&#xD;
&#xD;
         18. History of thyroid disease poorly controlled on prescribed medications;&#xD;
&#xD;
         19. Evidence of severe retinopathy or clinically relevant ophthalmologic disorder;&#xD;
&#xD;
         20. History of other severe disease or evidence of other severe disease or any other&#xD;
             illness or conditions that the investigator believe that patients are not suitable to&#xD;
             join in the study;&#xD;
&#xD;
         21. Patients included in another trial or having been given investigational drugs within&#xD;
             12 weeks prior to screening;&#xD;
&#xD;
         22. AFP(alpha feto protein)&gt;50ng/ml and/or evidence of hepatocellular carcinoma;&#xD;
&#xD;
         23. Other disease should exclusive considered by the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xinxin Zhang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ruijin Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xinxin Zhang</last_name>
    <email>zhangx@shsmu.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Xixi Hospital of Hangzhou</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaoqing Fu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Changhai Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mobin Wan</last_name>
      <email>mobinwan@aliyun.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hua shan Hospital,Fudan University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiming Zhang</last_name>
      <email>jmzhang@vip.126.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Infectious diesease hospital of Huangpu district in Shanghai</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hailin Liang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>No.9 hospital of shanghai</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jie Xu</last_name>
      <email>dr.xu@aliyun.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai public health clinical center</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liang Chen</last_name>
      <email>chenliang@shaphc.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shuguang Hospital of Shanghai T.C.M</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>yueqiu Gao</last_name>
      <email>gaoyueqiu@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tongren hospital Shanghai Jiaotong University School of medicine</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qin Zhang</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Marcellin P, Ahn SH, Ma X, Caruntu FA, Tak WY, Elkashab M, Chuang WL, Lim SG, Tabak F, Mehta R, Petersen J, Foster GR, Lou L, Martins EB, Dinh P, Lin L, Corsa A, Charuworn P, Subramanian GM, Reiser H, Reesink HW, Fung S, Strasser SI, Trinh H, Buti M, Gaeta GB, Hui AJ, Papatheodoridis G, Flisiak R, Chan HL; Study 149 Investigators. Combination of Tenofovir Disoproxil Fumarate and Peginterferon alpha-2a Increases Loss of Hepatitis B Surface Antigen in Patients With Chronic Hepatitis B. Gastroenterology. 2016 Jan;150(1):134-144.e10. doi: 10.1053/j.gastro.2015.09.043. Epub 2015 Oct 8.</citation>
    <PMID>26453773</PMID>
  </results_reference>
  <results_reference>
    <citation>Xie Q, Zhou H, Bai X, Wu S, Chen JJ, Sheng J, Xie Y, Chen C, Chan HL, Zhao M. A randomized, open-label clinical study of combined pegylated interferon Alfa-2a (40KD) and entecavir treatment for hepatitis B &quot;e&quot; antigen-positive chronic hepatitis B. Clin Infect Dis. 2014 Dec 15;59(12):1714-23. doi: 10.1093/cid/ciu702. Epub 2014 Sep 4.</citation>
    <PMID>25190434</PMID>
  </results_reference>
  <results_reference>
    <citation>Brouwer WP, Xie Q, Sonneveld MJ, Zhang N, Zhang Q, Tabak F, Streinu-Cercel A, Wang JY, Idilman R, Reesink HW, Diculescu M, Simon K, Voiculescu M, Akdogan M, Mazur W, Reijnders JG, Verhey E, Hansen BE, Janssen HL; ARES Study Group. Adding pegylated interferon to entecavir for hepatitis B e antigen-positive chronic hepatitis B: A multicenter randomized trial (ARES study). Hepatology. 2015 May;61(5):1512-22. doi: 10.1002/hep.27586. Epub 2015 Feb 27.</citation>
    <PMID>25348661</PMID>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>September 21, 2021</last_update_submitted>
  <last_update_submitted_qc>September 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruijin Hospital</investigator_affiliation>
    <investigator_full_name>Xinxin Zhang</investigator_full_name>
    <investigator_title>vice president of Ruijin hospital(North collegue)</investigator_title>
  </responsible_party>
  <keyword>HBeAg positive</keyword>
  <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>Tenofovir</mesh_term>
    <mesh_term>Peginterferon alfa-2a</mesh_term>
    <mesh_term>Interferon-alpha</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/NCT03013556
org study id: SHDC12016101
nct id: NCT03013556
lead sponsor: 
The current study is a prospective, randomized, open, multi-center investigation. The aim of
      the study is to investigate whether the HBeAg seroconversion rate can be improved if applying
      combination therapy in HBeAg positive CHB patients who has achieved
      HBVDNA<105copies/ml，HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2.
The HBeAg positive chronic hepatitis B(CHB) subjects who has achieved HBV
      DNA<10*5copies/ml，HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2 will be randomized to
      three groups. The subjects who go into group A will be treated by tenofovir disoproxil
      fumarate (TDF) for 96 weeks; The subjects who go into group B will be treated by TDF in the
      first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for
      another 48 weeks; The subjects who go into group C will be treated by the combination of TDF
      and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48
      weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of subjects who achieve HBeAg seroconversion
time frame: at 96 week
description: The number of subjects with HBeAg seroconversion at week 96 will be measured
measure: Number of participants who achieve HBeAg seroconversion
time frame: at 48 week;at 72 week
description: The number of subjects with HBeAg seroconversion at week 48 and 72 will be measured
measure: The percentage decrease of HBsAg level at group A,B,C
time frame: at 48 week;at 72 week;at 96 week
description: The level of HBsAg in group A,B,C at week 48 ,72 and 96 will be measured,changing from baseline
measure: Number of participants who achieve HBeAg loss
time frame: at 48 week;at 72 week;at 96 week
description: The number of subjects with HBeAg loss at week48.72 and 96 will be measured
measure: The number of subjects who achieve HBVDNA undetectable
time frame: at 24 week;48 week;at 72 week;at 96 week
description: The number of subjects with HBVDNA undetectable at week 24,48,72 and 96 will be measured
measure: The factor such as HBsAg level related to responsible rate
time frame: at week 48,72,96
description: The HBsAg level at week 48,72,96 will be measured, to assess whether the quantitative HBsAg level related to the responsible rate
measure: The number of subjects who achieve ALT back to normal
time frame: at 48 week;at 72 week;at 96 week
description: The number of subjects with normal ALT at week 48,72 and 96 will be measured
arm group label: Group A,TDF
arm group type: Active Comparator
description: The subjects in group A will be treated by TDF for 96 weeks
arm group label: Group B,TDF+PEG
arm group type: Experimental
description: The subjects in group B will be treated by TDF in the first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for another 48 weeks
arm group label: Group C,TDF+PEG
arm group type: Experimental
description: The subjects in group C will be treated by the combination of TDF and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48 weeks
intervention type: Drug
intervention name: Group A, TDF
description: TDF for 96 weeks
arm group label: Group A,TDF
other name: tenofovir
intervention type: Drug
intervention name: Group B:TDF then TDF and Peginterferon alfa-2a
description: Subjects will be treated by TDF in the first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for another 48 weeks
arm group label: Group B,TDF+PEG
other name: tenofovir,pegasys
intervention type: Drug
intervention name: Group C:TDF and Peginterferon alfa-2a then TDF
description: Subjects will be treated by the combination of TDF and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48 weeks.
arm group label: Group C,TDF+PEG
other name: tenofovir,pegasys
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Xinxin Zhang
role: Principal Investigator
affiliation: Ruijin Hospital
last name: Xinxin Zhang
email: zhangx@shsmu.edu.cn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
citation: Marcellin P, Ahn SH, Ma X, Caruntu FA, Tak WY, Elkashab M, Chuang WL, Lim SG, Tabak F, Mehta R, Petersen J, Foster GR, Lou L, Martins EB, Dinh P, Lin L, Corsa A, Charuworn P, Subramanian GM, Reiser H, Reesink HW, Fung S, Strasser SI, Trinh H, Buti M, Gaeta GB, Hui AJ, Papatheodoridis G, Flisiak R, Chan HL; Study 149 Investigators. Combination of Tenofovir Disoproxil Fumarate and Peginterferon alpha-2a Increases Loss of Hepatitis B Surface Antigen in Patients With Chronic Hepatitis B. Gastroenterology. 2016 Jan;150(1):134-144.e10. doi: 10.1053/j.gastro.2015.09.043. Epub 2015 Oct 8.
PMID: 26453773
citation: Xie Q, Zhou H, Bai X, Wu S, Chen JJ, Sheng J, Xie Y, Chen C, Chan HL, Zhao M. A randomized, open-label clinical study of combined pegylated interferon Alfa-2a (40KD) and entecavir treatment for hepatitis B "e" antigen-positive chronic hepatitis B. Clin Infect Dis. 2014 Dec 15;59(12):1714-23. doi: 10.1093/cid/ciu702. Epub 2014 Sep 4.
PMID: 25190434
citation: Brouwer WP, Xie Q, Sonneveld MJ, Zhang N, Zhang Q, Tabak F, Streinu-Cercel A, Wang JY, Idilman R, Reesink HW, Diculescu M, Simon K, Voiculescu M, Akdogan M, Mazur W, Reijnders JG, Verhey E, Hansen BE, Janssen HL; ARES Study Group. Adding pegylated interferon to entecavir for hepatitis B e antigen-positive chronic hepatitis B: A multicenter randomized trial (ARES study). Hepatology. 2015 May;61(5):1512-22. doi: 10.1002/hep.27586. Epub 2015 Feb 27.
PMID: 25348661
responsible party type: Principal Investigator
investigator affiliation: Ruijin Hospital
investigator full name: Xinxin Zhang
investigator title: vice president of Ruijin hospital(North collegue)
mesh term: Hepatitis A
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Hepatitis, Chronic
mesh term: Tenofovir
mesh term: Peginterferon alfa-2a
mesh term: Interferon-alpha