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Gilead 1059 GS-9620 for Chronic Hepatitis B
||A Phase 2, Randomized, Double-Blind, Placebo‑Controlled, Multi-center Study to Evaluate the Safety and Efficacy of GS‑9620 for the Treatment of Virally‑Suppressed Subjects with Chronic Hepatitis B
Hepatitis, Hepatitis B
||Hannah Lee, MD
GS-9620 is an experimental drug being tested as a possible treatment of chronic HBV infection and is not approved by the United States Food and Drug Administration (FDA). GS-9620 works by stimulating cells in your body to make interferon. Interferon is part of your body’s natural defense system against infection.
The purpose of this study is to determine how well your body tolerates GS-9620 and how it affects the HBV infection in your body, in addition to the oral antiviral (OAV) treatment regimen you are currently receiving. 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-9620 will only be given to you during your participation in the trial.
- Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months) with detectable HBsAg levels at screening
- Have been on approved HBV oral antiviral treatment for ≥ 1 year prior to screening
- Subjects currently taking an approved HBV oral antiviral (tenofovir, entecavir, adefovir, lamivudine or telbivudine, either as single agents or in combination) with no change in treatment regimen for 3 months prior to screening
- Extensive bridging fibrosis or cirrhosis
- Co-infection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV)
- Evidence of hepatocellular carcinoma
Taking part in this study will last 48 weeks not including the screening visit. During this time, you will be required to visit the clinic at least 15- 20 times, depending on which study group you are randomly assigned to. Blood and possibly urine samples will be taken at each visit to check your general health and response to the study drug. Over the entire 48 weeks of study, about 600-750 mL (2.5-3.2 cups) of blood will be drawn. If your study doctor suspects you have cancer, a CT scan may be performed as well. An ECG will be taken at your screening visit to make sure your heart is healthy.