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RECRUITING
NCT02995252

The HOPE Study: Characterizing Patients With Hepatitis B and C

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

OBSERVATIONAL

Enrollment

550

Start Date

2014-12

Completion Date

2034-12

Last Updated

2025-05-15

Healthy Volunteers

Yes

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.

Locations (2)

Institute of Human Virology, University of Maryland School of Medicine

Baltimore, Maryland, United States

Dr Huong Dang, Medical Practice

Falls Church, Virginia, United States