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Recruiting NCT02995252

The HOPE Study: Characterizing Patients With Hepatitis B and C

Trial Parameters

Condition Hepatitis B, Chronic
Sponsor University of Maryland, Baltimore
Study Type OBSERVATIONAL
Phase N/A
Enrollment 550
Sex ALL
Min Age 18 Years
Max Age 99 Years
Start Date 2014-12
Completion 2034-07
Interventions
Blood drawsTenofovir AlafenamideKnowledge Index Questionnaire

Brief 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 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 n

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