An Omnibus Protocol to Characterize Patients With Hepatitis B and C (the HOPE Study) With Hepatitis B Treatment Sub-study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Procedure, Drug
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
View:

• 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.

Locations
United States
Maryland
Institute of Human Virology, University of Maryland School of Medicine
RECRUITING
Baltimore
Virginia
Dr Huong Dang, Medical Practice
RECRUITING
Falls Church
Contact Information
Primary
Lydia Tang, MBChB
LydiaTang@IHV.umaryland.edu
(410) 706-6567
Time Frame
Start Date: 2014-12
Estimated Completion Date: 2034-12
Participants
Target number of participants: 550
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: University of Maryland, Baltimore

This content was sourced from clinicaltrials.gov