RecruitingNCT02995252

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

Sponsor

University of Maryland, Baltimore

Enrollment

550 participants

Start Date

Dec 1, 2014

Study Type

OBSERVATIONAL

Conditions

Hepatitis C Hepatitis B, Chronic

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

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is following people with hepatitis B, hepatitis C, HIV, or combinations of these infections over time to understand how these diseases progress and how the immune system responds — including people who have successfully cleared or been cured of hepatitis B or C, and healthy volunteers. **You may be eligible if...** - You are at least 18 years old - You have hepatitis B and/or C (active or past infection), with or without HIV, OR you are a healthy volunteer with no history of hepatitis B, C, or HIV - You have been treated for hepatitis C and achieved a cure (SVR) - You have a primary care doctor or are working on establishing one - You are willing to have samples stored for future research **You may NOT be eligible if...** - You are under 18 years old - You do not have an identifiable primary care provider (or are not in the process of getting one) - You are unwilling to have your samples stored Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBlood draws

DRUGTenofovir Alafenamide

25 mg tablet, once a day by mouth.

OTHERKnowledge Index Questionnaire

OTHERLiver transient elastography (FibroScan)

Participants of the hepatitis B treatment sub-study may have FibroScans completed at baseline, during the study with liver enzyme normalization, and at the end of the study.

PROCEDURELiver Biopsy

40 participants of the hepatitis B treatment sub-study will have liver biopsies prior to starting tenofovir alafenamide, and at years 1 and 2 of receiving treatment.