The HOPE Study: Characterizing Patients With Hepatitis B and C

NCT02995252 | Recruiting

• 1 other identifier: HP-00063191
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hepatitis B， Chronic; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Change in liver stiffness among participants with chronic hepatitis B infection

  Participants will be provided with the nucleotide analogue, tenofovir alafenamide. Change in liver stiffness as measured by transient elastography (FibroScan) before starting tenofovir alafenamide, at time of liver enzyme normalization, and at 2 years of treatment.

  2 years

Study Arms (2)

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.

Other: Blood draws; Other: Knowledge Index Questionnaire

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.

Other: Blood draws; Drug: Tenofovir Alafenamide; Other: Knowledge Index Questionnaire; Other: Liver transient elastography (FibroScan); Procedure: Liver Biopsy

Interventions

Blood draws OTHER

Group 1: Hepatitis C infection; Group 2: Hepatitis B infection

Tenofovir Alafenamide DRUG

25 mg tablet, once a day by mouth.

Group 2: Hepatitis B infection

Knowledge Index Questionnaire OTHER

Group 1: Hepatitis C infection; Group 2: Hepatitis B infection

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.

Group 2: Hepatitis B infection

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.

Group 2: Hepatitis B infection

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with chronic hepatitis B and/or C, with or without HIV infection. Or people who have cleared hepatitis B infection, or been treated for hepatitis C infection with direct acting antiviral agents.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (2)

Institute of Human Virology, University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

RECRUITING

Dr Huong Dang, Medical Practice

Falls Church, Virginia, 22044, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

one sample of blood is collected and stored for future analysis of genetic markers relevant to disease outcomes.

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis C

Interventions

Blood Specimen Collection; tenofovir alafenamide

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Flaviviridae Infections; RNA Virus Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Lydia Tang, MBChB

  Institute of Human Virology, University of Maryland School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lydia Tang, MBChB

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 16, 2016
• Study Start: December 1, 2014
• Primary Completion (Estimated): July 1, 2034
• Study Completion (Estimated): December 1, 2034
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)