Characterizing patients with chronic hepatitis B and C

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

This study is looking to learn more about chronic hepatitis B and C by collecting samples from patients over 10 years to see how the diseases progress and how treatments work.

Quick facts

• Study type: Observational
• Enrollment: 550 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: University of Maryland, Baltimore (other)
• Locations: 2 sites (Baltimore, Maryland and 1 other locations)
• Trial ID: NCT02995252 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect and evaluate samples from patients with chronic hepatitis B and C over a period of up to 10 years. Participants will be seen annually and may have additional visits, during which they will provide samples for research on disease progression and treatment. The study also includes a sub-study for hepatitis B treatment involving two years of therapy with tenofovir alafenamide, along with blood collections and optional liver biopsies. The goal is to link patients to care and assess the immunopathogenesis of these viral infections.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are infected with hepatitis B and/or C, have a history of infection, or are healthy volunteers without these infections.

Not a fit: Patients who are unable to comply with study visits or have contraindications to participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve understanding and management of chronic hepatitis B and C, leading to better patient outcomes.

How similar studies have performed: Other studies have shown success in characterizing hepatitis infections and their treatments, making this approach both relevant and promising.

Eligibility criteria

Inclusion 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.

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 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

Where this trial is running

Baltimore, Maryland and 1 other locations

• Institute of Human Virology, University of Maryland School of Medicine — Baltimore, Maryland, United States (RECRUITING)
• Dr Huong Dang, Medical Practice — Falls Church, Virginia, United States (RECRUITING)

Study contacts

• Principal investigator: Lydia Tang, MBChB — Institute of Human Virology, University of Maryland School of Medicine
• Study coordinator: Lydia Tang, MBChB

Conditions: Hepatitis B， Chronic, Hepatitis C