NCT02995252Active, not recruiting
The HOPE Study: Characterizing Patients With Hepatitis B and C
An Omnibus Protocol to Characterize Patients With Hepatitis B and C (the HOPE Study) With Hepatitis B Treatment Sub-study
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 550 (estimated)
- First submitted
- 13 Dec 2016
- Start date
- Dec 2014
- Primary completion date
- Jul 2034
- Lead sponsor
- University of Maryland, Baltimore
- Diseases
- Hepatitis B
- NCT number
- NCT02995252
What you commit to
- Study type: Observational
- Planned participants: 550
- From Dec 2014 to the primary completion date, Jul 2034
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Have any condition that the investigator considers a contraindication to study participation.
- Pregnant or breastfeeding women will not be eligible to participate in the HBV treatment sub-study
Lab values
- Poor venous access not allowing screening laboratory collection
Other
- Unable to comply with research study visits
Who the study is looking for
- At least 18 years old
- 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
- Willing to have samples stored for future research
- Must have an identifiable primary care provider or be in the process of establishing a primary care provider
- Willing to undergo HIV testing if not recently documented
- Inclusion in the HBV treatment sub-study will be dependent on eligibility to receive nucleos(t)ide analogue therapy according to standard-of-care.
Age in the registry: 18 years to 99 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Human Virology, University of Maryland School of Medicine Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Dr Huong Dang, Medical Practice Coordinator of this site? Confirm its status | Falls Church | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.