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The HOPE Study: Characterizing Patients With Hepatitis B and C

NCT02995252 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 550

Last updated 2025-05-15

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Lydia Tang, MBChB · Institute of Human Virology, University of Maryland School of Medicine

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2034-07-31
Completion
2034-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02995252 on ClinicalTrials.gov