The HOPE Study: Characterizing Patients With Hepatitis B and C

Description

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.

Conditions

Hepatitis B， Chronic, Hepatitis C

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

An Omnibus Protocol to Characterize Patients With Hepatitis B and C (the HOPE Study) With Hepatitis B Treatment Sub-study

The HOPE Study: Characterizing Patients With Hepatitis B and C

Condition
Hepatitis B， Chronic
Intervention / Treatment

-

Contacts and Locations

Baltimore

Institute of Human Virology, University of Maryland School of Medicine, Baltimore, Maryland, United States, 21201

Falls Church

Dr Huong Dang, Medical Practice, Falls Church, Virginia, United States, 22044

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. At least 18 years old
  • 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.
  • 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 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

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Maryland, Baltimore,

Lydia Tang, MBChB, PRINCIPAL_INVESTIGATOR, Institute of Human Virology, University of Maryland School of Medicine

Study Record Dates

2025-12