The HOPE Study: Characterizing Patients With Hepatitis B and C
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 diseas
| Condition(s) | Hepatitis B， Chronic, Hepatitis C |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 la |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | University of Maryland, Baltimore |
| Locations | Baltimore, Maryland, United States; Falls Church, Virginia, United States |
| Start date | 2014-12 |
| NCT ID | NCT02995252 |
| Official listing | https://clinicaltrials.gov/study/NCT02995252 |