<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/NCT02995252</url>
  </required_header>
  <id_info>
    <org_study_id>HP-00063191</org_study_id>
    <nct_id>NCT02995252</nct_id>
  </id_info>
  <brief_title>The HOPE Study: Characterizing Patients With Hepatitis B and C</brief_title>
  <official_title>An Omnibus Protocol to Characterize Patients With Hepatitis B and C (the HOPE Study) With Hepatitis B Treatment Sub-study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Maryland, Baltimore</source>
  <brief_summary>
    <textblock>
      This is an observational, longitudinal, prospective study for sample collection and&#xD;
      evaluation for future therapy or disease progression of chronic hepatitis B and C.&#xD;
      Participants will be seen on an annual basis with optional additional visits for up to 10&#xD;
      years and provide samples for research and evaluation of disease progression. In addition,&#xD;
      there is a longitudinal sub-study for treatment of hepatitis B that will involve 2 years of&#xD;
      treatment with tenofovir alafenamide and blood collections with optional liver biopsies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hepatitis B virus chronically infects 350 million people worldwide and over one million&#xD;
      Americans and approximately 4.1 million individuals (1.6%) in the US population have been&#xD;
      infected with hepatitis C. These infections are the leading cause of end-stage liver disease,&#xD;
      cancer and indication for liver transplantation in the world. Both can be transmitted&#xD;
      sexually, perinatally and percutaneously. Coinfected with human immunodeficiency virus (HIV)&#xD;
      accelerates the progression of liver disease, and due to shared modes of transmission,&#xD;
      chronic hepatitis B and C disproportionately affect people living with HIV.&#xD;
&#xD;
      The primary objective of this study is to Identify people with viral hepatitis and providing&#xD;
      linkage to care and future therapy with evaluation of disease progression; as well as&#xD;
      characterizing those with hepatitis B and those treated for hepatitis C with directly acting&#xD;
      antivirals over the course of 10 years.&#xD;
&#xD;
      The study, including a participant questionnaire and phlebotomy, will be administered on-site&#xD;
      at clinical facilities in the District of Columbia and Maryland, and at the Institute of&#xD;
      Human Virology at the University of Maryland, Baltimore. The cohort will be designed to study&#xD;
      research questions with respect to liver disease, disease pathogenesis using genomics,&#xD;
      proteomics, and immunologic disease models. Secondary objectives include study of the&#xD;
      immunopathogenesis of hepatitis B and C disease progression. In addition, this is an&#xD;
      invaluable opportunity to evaluate the long term effects of hepatitis C clearance with direct&#xD;
      acting antivirals, along with biomarker profile(s) for diagnosis and outcome. Moreover, this&#xD;
      will serve as a catchment protocol to select appropriate participants for novel hepatitis B&#xD;
      and C therapeutic trials.&#xD;
&#xD;
      This study includes a standard-of-care treatment sub-study for patients with hepatitis B. In&#xD;
      this sub-study, participants will receive an approved nucleos(t)ide analogue prospectively&#xD;
      observed on therapy for change in liver fibrosis.&#xD;
&#xD;
      The integrated clinics will provide an optimal environment for the adherence and engagement&#xD;
      of medical care and education in decreasing transmission risks of infection. The study will&#xD;
      establish a blood and specimen repository for participants and include a research database&#xD;
      that will be used prospectively to test future hypotheses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2025</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>Change in liver stiffness among participants with chronic hepatitis B infection</measure>
    <time_frame>2 years</time_frame>
    <description>Participants will be provided with the nucleotide analogue, tenofovir alafenamide. Change in liver stiffness as measured by transient elastography (FibroScan) before starting tenofovir alafenamide, at time of liver enzyme normalization, and at 2 years of treatment.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">550</enrollment>
  <condition>Hepatitis B， Chronic</condition>
  <condition>Hepatitis C</condition>
  <arm_group>
    <arm_group_label>Group 1: Hepatitis C infection</arm_group_label>
    <description>Participants with chronic hepatitis C infection; includes both hepatitis C mono infected and hepatitis C-HIV coinfected. Participants will attend study visits for research blood draws (once a year with optional additional visits), and a one-time optional knowledge questionnaire. No drugs will be given to this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: Hepatitis B infection</arm_group_label>
    <description>Participants with chronic hepatitis B: includes patients with hepatitis B with and without hepatitis C and/or HIV. Participants will attend study visits for research blood draws (once a year with optional additional visits), and a one-time optional knowledge questionnaire. Participants who are already taking hepatitis B treatment are eligible.&#xD;
Hepatitis B treatment sub-study: In this treatment sub-study, participants with hepatitis B monoinfection will receive tenofovir alafenamide (TAF) pill once a day for 2 years with study visits every 3 months. Liver transient elastography will be reviewed or obtained. In addition, approximately 40 participants will be invited to undergo optional liver biopsies at the start, end of year 1 and end of year 2 of the sub-study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood draws</intervention_name>
    <arm_group_label>Group 1: Hepatitis C infection</arm_group_label>
    <arm_group_label>Group 2: Hepatitis B infection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tenofovir Alafenamide</intervention_name>
    <description>25 mg tablet, once a day by mouth.</description>
    <arm_group_label>Group 2: Hepatitis B infection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Knowledge Index Questionnaire</intervention_name>
    <arm_group_label>Group 1: Hepatitis C infection</arm_group_label>
    <arm_group_label>Group 2: Hepatitis B infection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Liver transient elastography (FibroScan)</intervention_name>
    <description>Participants of the hepatitis B treatment sub-study may have FibroScans completed at baseline, during the study with liver enzyme normalization, and at the end of the study.</description>
    <arm_group_label>Group 2: Hepatitis B infection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Liver Biopsy</intervention_name>
    <description>40 participants of the hepatitis B treatment sub-study will have liver biopsies prior to starting tenofovir alafenamide, and at years 1 and 2 of receiving treatment.</description>
    <arm_group_label>Group 2: Hepatitis B infection</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      one sample of blood is collected and stored for future analysis of genetic markers relevant&#xD;
      to disease outcomes.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        People with chronic hepatitis B and/or C, with or without HIV infection. Or people who have&#xD;
        cleared hepatitis B infection, or been treated for hepatitis C infection with direct acting&#xD;
        antiviral agents.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. At least 18 years old&#xD;
&#xD;
          2. Hepatitis B and/or C-infected; or history of hepatitis B infection, but cleared; or&#xD;
             hepatitis C infection and successfully treated with direct acting antiviral agents,&#xD;
             with or without HIV infection; or healthy volunteer without history of HBV and/or C,&#xD;
             nor HIV&#xD;
&#xD;
          3. Willing to have samples stored for future research&#xD;
&#xD;
          4. Must have an identifiable primary care provider or be in the process of establishing a&#xD;
             primary care provider&#xD;
&#xD;
          5. Willing to undergo HIV testing if not recently documented&#xD;
&#xD;
          6. Inclusion in the HBV treatment sub-study will be dependent on eligibility to receive&#xD;
             nucleos(t)ide analogue therapy according to standard-of-care.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Unable to comply with research study visits&#xD;
&#xD;
          2. Poor venous access not allowing screening laboratory collection&#xD;
&#xD;
          3. Have any condition that the investigator considers a contraindication to study&#xD;
             participation.&#xD;
&#xD;
          4. HBV monoinfected participants with any contraindications to HBV treatment with&#xD;
             nucleos(t)ide analogues will be ineligible to participate in the HBV treatment&#xD;
             sub-study.&#xD;
&#xD;
          5. Pregnant or breastfeeding women will not be eligible to participate in the HBV&#xD;
             treatment sub-study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lydia Tang, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Human Virology, University of Maryland School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christine Lin, BA</last_name>
    <phone>(410) 706-3367</phone>
    <email>Christine.Lin@IHV.umaryland.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institute of Human Virology, University of Maryland School of Medicine</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christine Lin, BA</last_name>
      <phone>410-706-3367</phone>
      <email>Christine.Lin@ihv.umaryland.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Dr Huong Dang, Medical Practice</name>
      <address>
        <city>Falls Church</city>
        <state>Virginia</state>
        <zip>22044</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christine Lin, BA</last_name>
      <phone>410-706-3367</phone>
      <email>Christine.Lin@ihv.umaryland.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>March 10, 2023</last_update_submitted>
  <last_update_submitted_qc>March 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Lydia Tang</investigator_full_name>
    <investigator_title>MD</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 C</mesh_term>
    <mesh_term>Hepatitis B</mesh_term>
    <mesh_term>Hepatitis B, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tenofovir</mesh_term>
    <mesh_term>Liver Extracts</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/NCT02995252
org study id: HP-00063191
nct id: NCT02995252
lead sponsor: 
This is an observational, longitudinal, prospective study for sample collection and
      evaluation for future therapy or disease progression of chronic hepatitis B and C.
      Participants will be seen on an annual basis with optional additional visits for up to 10
      years and provide samples for research and evaluation of disease progression. In addition,
      there is a longitudinal sub-study for treatment of hepatitis B that will involve 2 years of
      treatment with tenofovir alafenamide and blood collections with optional liver biopsies.
Hepatitis B virus chronically infects 350 million people worldwide and over one million
      Americans and approximately 4.1 million individuals (1.6%) in the US population have been
      infected with hepatitis C. These infections are the leading cause of end-stage liver disease,
      cancer and indication for liver transplantation in the world. Both can be transmitted
      sexually, perinatally and percutaneously. Coinfected with human immunodeficiency virus (HIV)
      accelerates the progression of liver disease, and due to shared modes of transmission,
      chronic hepatitis B and C disproportionately affect people living with HIV.

      The primary objective of this study is to Identify people with viral hepatitis and providing
      linkage to care and future therapy with evaluation of disease progression; as well as
      characterizing those with hepatitis B and those treated for hepatitis C with directly acting
      antivirals over the course of 10 years.

      The study, including a participant questionnaire and phlebotomy, will be administered on-site
      at clinical facilities in the District of Columbia and Maryland, and at the Institute of
      Human Virology at the University of Maryland, Baltimore. The cohort will be designed to study
      research questions with respect to liver disease, disease pathogenesis using genomics,
      proteomics, and immunologic disease models. Secondary objectives include study of the
      immunopathogenesis of hepatitis B and C disease progression. In addition, this is an
      invaluable opportunity to evaluate the long term effects of hepatitis C clearance with direct
      acting antivirals, along with biomarker profile(s) for diagnosis and outcome. Moreover, this
      will serve as a catchment protocol to select appropriate participants for novel hepatitis B
      and C therapeutic trials.

      This study includes a standard-of-care treatment sub-study for patients with hepatitis B. In
      this sub-study, participants will receive an approved nucleos(t)ide analogue prospectively
      observed on therapy for change in liver fibrosis.

      The integrated clinics will provide an optimal environment for the adherence and engagement
      of medical care and education in decreasing transmission risks of infection. The study will
      establish a blood and specimen repository for participants and include a research database
      that will be used prospectively to test future hypotheses.
observational model: Cohort
time perspective: Prospective
measure: Change in liver stiffness among participants with chronic hepatitis B infection
time frame: 2 years
description: Participants will be provided with the nucleotide analogue, tenofovir alafenamide. Change in liver stiffness as measured by transient elastography (FibroScan) before starting tenofovir alafenamide, at time of liver enzyme normalization, and at 2 years of treatment.
arm group label: Group 1: Hepatitis C infection
description: Participants with chronic hepatitis C infection; includes both hepatitis C mono infected and hepatitis C-HIV coinfected. Participants will attend study visits for research blood draws (once a year with optional additional visits), and a one-time optional knowledge questionnaire. No drugs will be given to this group.
arm group label: Group 2: Hepatitis B infection
description: Participants with chronic hepatitis B: includes patients with hepatitis B with and without hepatitis C and/or HIV. Participants will attend study visits for research blood draws (once a year with optional additional visits), and a one-time optional knowledge questionnaire. Participants who are already taking hepatitis B treatment are eligible.
Hepatitis B treatment sub-study: In this treatment sub-study, participants with hepatitis B monoinfection will receive tenofovir alafenamide (TAF) pill once a day for 2 years with study visits every 3 months. Liver transient elastography will be reviewed or obtained. In addition, approximately 40 participants will be invited to undergo optional liver biopsies at the start, end of year 1 and end of year 2 of the sub-study.
intervention type: Other
intervention name: Blood draws
arm group label: Group 1: Hepatitis C infection
arm group label: Group 2: Hepatitis B infection
intervention type: Drug
intervention name: Tenofovir Alafenamide
description: 25 mg tablet, once a day by mouth.
arm group label: Group 2: Hepatitis B infection
intervention type: Other
intervention name: Knowledge Index Questionnaire
arm group label: Group 1: Hepatitis C infection
arm group label: Group 2: Hepatitis B infection
intervention type: Other
intervention name: Liver transient elastography (FibroScan)
description: Participants of the hepatitis B treatment sub-study may have FibroScans completed at baseline, during the study with liver enzyme normalization, and at the end of the study.
arm group label: Group 2: Hepatitis B infection
intervention type: Procedure
intervention name: Liver Biopsy
description: 40 participants of the hepatitis B treatment sub-study will have liver biopsies prior to starting tenofovir alafenamide, and at years 1 and 2 of receiving treatment.
arm group label: Group 2: Hepatitis B infection
one sample of blood is collected and stored for future analysis of genetic markers relevant
      to disease outcomes.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lydia Tang, MBChB
role: Principal Investigator
affiliation: Institute of Human Virology, University of Maryland School of Medicine
last name: Christine Lin, BA
phone: (410) 706-3367
email: Christine.Lin@IHV.umaryland.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Lydia Tang
investigator title: MD
mesh term: Hepatitis A
mesh term: Hepatitis C
mesh term: Hepatitis B
mesh term: Hepatitis B, Chronic
mesh term: Hepatitis
mesh term: Tenofovir
mesh term: Liver Extracts