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Gilead 0149 TDF + PEG


Title A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon alpha-2a (Pegasys) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon alpha-2a Monotherapy for 48 weeks in Non-Cirrhotic Subjects with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)
Therapeutic Area Hepatitis, Hepatitis B
Principal Investigator Hannah Lee, MD
Min Age 18 Years
Max Age 75 Years
Gender Both
Contact Veronika Testa
617-636-2379
More Information http://clinicaltrials.gov/ct2/show/NCT01277601

Overview

This study involves a daily pill which is a commercially available drug named tenofovir DF (TDF) for the treatment of chronic Hepatitis B virus.  This drug TDF will be given alone or in combination with a weekly shot of another commercially available drug called Pegylated Interferon alfa (PEG).  Both drugs have been shown to be good at lowering the amount of virus in the blood on their own.  This study will see if they work better together than they do alone.

Study Details

Inclusion Criteria

  • Anti-HBV treatment naïve subjects. Subjects who have taken < 12 weeks of oral anti-HBV nucleoside therapy with the last dose ≥ 24 weeks prior to screening are also eligible.
  • HBV DNA HBeAg- and HBeAg+ subjects ≥ 20,000 IU/ml
  • Creatinine clearance rate ≥ 70 mL/min

Exclusion Criteria

  • Known bridging fibrosis or cirrhosis and/or decompensated liver disease
  • Evidence of hepatocellular carcinoma
  • Co-infection with HIV, HCV or HDV

Study Requirements

Your participation in this study will last about 120 weeks (2⅓ years) not including the screening visit and includes about 22 visits. TDF tablets are taken by mouth once a day. Peginterferon alfa 2a (Pegasys® or PEG) must be injected under the skin at a dose of 180 μg/0.5 mL (about 1/10 teaspoon) once a week.  The first injection will be done at the study doctor’s office and the study team can show you how to do this at home for future injections if you prefer.

At the screening visit you will need to have a CT scan or ultrasound of your liver taken. Blood will be drawn at each visit with the maximum volume of 48 mL (slightly more than 3 tablespoons) taken each time.