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The HOPE Study: Characterizing Patients With Hepatitis B and C
Sponsor: University of Maryland, Baltimore
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
Conditions
Interventions
Blood draws
Tenofovir Alafenamide
25 mg tablet, once a day by mouth.
Knowledge Index Questionnaire
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.
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