The HOPE Study: Characterizing Patients With Hepatitis B and C

Last updated: April 2, 2024
Sponsor: University of Maryland, Baltimore
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatitis B

Hepatitis

Liver Disorders

Treatment

Blood draws

Liver transient elastography (FibroScan)

Tenofovir Alafenamide

Clinical Study ID

NCT02995252
HP-00063191
  • Ages 18-99
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. At least 18 years old
  2. Hepatitis B and/or C-infected; or history of hepatitis B infection, but cleared; orhepatitis 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 aprimary 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 receivenucleos(t)ide analogue therapy according to standard-of-care.

Exclusion

Exclusion Criteria:

  1. Unable to comply with research study visits
  2. Poor venous access not allowing screening laboratory collection
  3. Have any condition that the investigator considers a contraindication to studyparticipation.
  4. HBV monoinfected participants with any contraindications to HBV treatment withnucleos(t)ide analogues will be ineligible to participate in the HBV treatmentsub-study.
  5. Pregnant or breastfeeding women will not be eligible to participate in the HBVtreatment sub-study

Study Design

Total Participants: 550
Treatment Group(s): 5
Primary Treatment: Blood draws
Phase:
Study Start date:
December 01, 2014
Estimated Completion Date:
December 31, 2025

Study Description

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.

Connect with a study center

  • Unity Health Care, Inc./Walker Jones

    Washington, District of Columbia 20002
    United States

    Site Not Available

  • Unity Health Care, Inc./Walker Jones

    Washington, D.C., District of Columbia 20002
    United States

    Site Not Available

  • Unity Health Care, Inc./Walker Jones

    Washington, DC, District of Columbia 20002
    United States

    Site Not Available

  • Institute of Human Virology, University of Maryland School of Medicine

    Baltimore, Maryland 21201
    United States

    Active - Recruiting

  • Pan Asian Volunteer Health Clinic at the Chinese Culture and Community Service Center

    Gaithersburg, Maryland 20877
    United States

    Site Not Available

  • Dr Huong Dang, Medical Practice

    Falls Church, Virginia 22044
    United States

    Active - Recruiting

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