NCT02995252

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 550 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Detailed description

Hepatitis B virus chronically infects 350 million people worldwide and over one million Americans and approximately 4.1 million individuals (1.6%) in the US population have been infected with hepatitis C. These infections are the leading cause of end-stage liver disease, cancer and indication for liver transplantation in the world. Both can be transmitted sexually, perinatally and percutaneously. Coinfected with human immunodeficiency virus (HIV) accelerates the progression of liver disease, and due to shared modes of transmission, chronic hepatitis B and C disproportionately affect people living with HIV. The primary objective of this study is to Identify people with viral hepatitis and providing linkage to care and future therapy with evaluation of disease progression; as well as characterizing those with hepatitis B and those treated for hepatitis C with directly acting antivirals over the course of 10 years. The study, including a participant questionnaire and phlebotomy, will be administered on-site at clinical facilities in the District of Columbia and Maryland, and at the Institute of Human Virology at the University of Maryland, Baltimore. The cohort will be designed to study research questions with respect to liver disease, disease pathogenesis using genomics, proteomics, and immunologic disease models. Secondary objectives include study of the immunopathogenesis of hepatitis B and C disease progression. In addition, this is an invaluable opportunity to evaluate the long term effects of hepatitis C clearance with direct acting antivirals, along with biomarker profile(s) for diagnosis and outcome. Moreover, this will serve as a catchment protocol to select appropriate participants for novel hepatitis B and C therapeutic trials. This study includes a standard-of-care treatment sub-study for patients with hepatitis B. In this sub-study, participants will receive an approved nucleos(t)ide analogue prospectively observed on therapy for change in liver fibrosis. The integrated clinics will provide an optimal environment for the adherence and engagement of medical care and education in decreasing transmission risks of infection. The study will establish a blood and specimen repository for participants and include a research database that will be used prospectively to test future hypotheses.

Conditions

• Hepatitis B， Chronic
• Hepatitis C

Interventions

Type	Name	Description
OTHER	Blood draws
DRUG	Tenofovir Alafenamide	25 mg tablet, once a day by mouth.
OTHER	Knowledge Index Questionnaire
OTHER	Liver 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.
PROCEDURE	Liver 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.

Timeline

• Start date: 2014-12-01
• Primary completion: 2034-07-01
• Completion: 2034-12-01
• First posted: 2016-12-16
• Last updated: 2025-05-15

Locations

2 sites across 1 country: United States