RecruitingNot Applicable

The HOPE Study: Characterizing Patients With Hepatitis B and C

United States550 participantsStarted 2014-12

Plain-language 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

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. Unable to comply with research study visits
✕. Poor venous access not allowing screening laboratory collection
✕. Have any condition that the investigator considers a contraindication to study participation.
✕. 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.
✕. Pregnant or breastfeeding women will not be eligible to participate in the HBV treatment sub-study

What they're measuring

Change in liver stiffness among participants with chronic hepatitis B infection

Timeframe: 2 years

Trial details

NCT IDNCT02995252

SponsorUniversity of Maryland, Baltimore

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2034-07

Contact for this trial

Lydia Tang, MBChB

(410) 706-6567 LydiaTang@IHV.umaryland.edu

View on ClinicalTrials.gov More Hepatitis B， Chronic trials