Clinical Trial

Characterizing Patients with Hepatitis B and C

Study Description

The HOPE Study: Characterizing Patients With Hepatitis B and C

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Blood draws

Drug - 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.

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.

Additional Information

Official Study Title

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

Clinical Trial ID

NCT02995252

ParticipAid ID

negPGa