The HOPE Study: Characterizing Patients With Hepatitis B and C
NCT ID: NCT02995252
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
550 participants
OBSERVATIONAL
2014-12-31
2034-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1: Hepatitis C infection
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.
Blood draws
Knowledge Index Questionnaire
Group 2: Hepatitis B infection
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.
Blood draws
Tenofovir Alafenamide
25 mg tablet, once a day by mouth.
Knowledge Index Questionnaire
Liver transient elastography (FibroScan)
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.
Liver Biopsy
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.
Interventions
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Blood draws
Tenofovir Alafenamide
25 mg tablet, once a day by mouth.
Knowledge Index Questionnaire
Liver transient elastography (FibroScan)
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.
Liver Biopsy
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.
Eligibility Criteria
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Inclusion Criteria
2. Hepatitis B and/or C-infected; or history of hepatitis B infection, but cleared; or hepatitis C infection and successfully treated with direct acting antiviral agents, with or without HIV infection; or healthy volunteer without history of HBV and/or C, nor HIV
3. Willing to have samples stored for future research
4. Must have an identifiable primary care provider or be in the process of establishing a primary care provider
5. Willing to undergo HIV testing if not recently documented
6. Inclusion in the HBV treatment sub-study will be dependent on eligibility to receive nucleos(t)ide analogue therapy according to standard-of-care.
Exclusion Criteria
2. Poor venous access not allowing screening laboratory collection
3. Have any condition that the investigator considers a contraindication to study participation.
4. HBV monoinfected participants with any contraindications to HBV treatment with nucleos(t)ide analogues will be ineligible to participate in the HBV treatment sub-study.
5. Pregnant or breastfeeding women will not be eligible to participate in the HBV treatment sub-study
18 Years
99 Years
ALL
Yes
Sponsors
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University of Maryland, Baltimore
OTHER
Responsible Party
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Lydia Tang
MD
Principal Investigators
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Lydia Tang, MBChB
Role: PRINCIPAL_INVESTIGATOR
Institute of Human Virology, University of Maryland School of Medicine
Locations
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Institute of Human Virology, University of Maryland School of Medicine
Baltimore, Maryland, United States
Dr Huong Dang, Medical Practice
Falls Church, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HP-00063191
Identifier Type: -
Identifier Source: org_study_id
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