The HOPE Study: Characterizing Patients With Hepatitis B and C

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT02995252
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • Blood draws — OTHER
  • Tenofovir Alafenamide — DRUG
    25 mg tablet, once a day by mouth.
  • Knowledge Index Questionnaire — OTHER
  • Liver transient elastography (FibroScan) — OTHER
    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.
  • Liver Biopsy — PROCEDURE
    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.

Study Details

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.

Key Dates

Start date
Dec 31, 2014
Status verified
May 2025
Primary completion
Jul 31, 2034
Completion
Dec 31, 2034

Study Design

Enrollment
550 participants (estimated)

Arms

  • Arm: Group 1: Hepatitis C infection
    Participants with chronic hepatitis C infection; includes both hepatitis C mono infected and hepatitis C-HIV coinfected. Participants will attend study visits for research blood draws (once a year with optional additional visits), and a one-time optional knowledge questionnaire. No drugs will be given to this group.
  • Arm: Group 2: Hepatitis B infection
    Participants with chronic hepatitis B: includes patients with hepatitis B with and without hepatitis C and/or HIV. Participants will attend study visits for research blood draws (once a year with optional additional visits), and a one-time optional knowledge questionnaire. Participants who are already taking hepatitis B treatment are eligible. Hepatitis B treatment sub-study: In this treatment sub-study, participants with hepatitis B monoinfection will receive tenofovir alafenamide (TAF) pill once a day for 2 years with study visits every 3 months. Liver transient elastography will be reviewed or obtained. In addition, approximately 40 participants will be invited to undergo optional liver biopsies at the start, end of year 1 and end of year 2 of the sub-study.

Primary Outcome Measure

Change in liver stiffness among participants with chronic hepatitis B infection [ Time Frame: 2 years ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Institute of Human Virology, University of Maryland School of MedicineBaltimoreMaryland21201
Lydia Tang, MBChB
[email protected]
(410) 706-6567
Dr Huong Dang, Medical PracticeFalls ChurchVirginia22044
Lydia Tang, MBChB
[email protected]
410 706 6567

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By research site
Institute of Human Virology, University of Maryland School of Medicine· Baltimore, MDDr Huong Dang, Medical Practice· Falls Church, VA

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