A Phase 2 Randomized Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 in combination with Tenofovir Disoproxil Fumarate (TDF) for the treatment of subjects with chronic hepatitis B and who are currently not on treatment
ID Number 14-1856Principal Investigator(s)
Department(s) or Division(s)
Subjects are being asked to take part in a clinical research study involving an experimental vaccine named GS-4774 in combination with Tenofovir Disoproxil Fumarate (TDF) for the treatment of chronic hepatitis B.
GS-4774 is not approved in any country for the treatment of hepatitis B infection, and its use in this study is considered experimental. GS-4774 is an experimental (investigational) vaccine being tested as a possible treatment of chronic Hepatitis B and is not yet approved by the United States Food and Drug Administration (FDA).
GS-4774 has been designed to stimulate the immune system, the system that the body uses to defend itself from infections. GS-4774 is produced from "baker's yeast" which has been changed to include the substance found in the Hepatitis B virus. This yeast has been heat inactivated and subjects will not be receiving live yeast. Studies in healthy subjects have shown that GS-4774 stimulated the immune system to help block the spread of Hepatitis B virus.
The purpose of this study is to determine how well the body tolerates GS-4774 in combination with Tenofovir Disoproxil Fumarate (TDF) and how it affects the HBV infection in the body. The study is for research purposes only and is not intended or expected to cure any medical conditions. As this is a research study, GS-4774 and TDF will only be given to volunteers during their participation in the trial.
Recruiting Patients: No