A Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection

The overall goal of this trial is to evaluate the efficacy of FG-3019 for reversing liver fibrosis in subjects with chronic hepatitis B infection who are beginning antiviral therapy with entecavir. This Phase 2 randomized, double-blind, placebo controlled study will enroll subjects with chronic active hepatitis B infection and liver fibrosis (Ishak score ≥2) who are eligible for antiviral therapy.

Inclusion Criteria

• Signed informed consent
• Age of 18 to 75 years, inclusive
• HBsAg positive for ≥24 weeks prior to screening
• Liver fibrosis, confirmed by biopsy and histology
• Willing to use contraception

Exclusion Criteria:

• Female subjects who are pregnant or nursing
• Prior antiviral therapy, with the exception of interferon therapy >6 months prior to Day 1
• Severe heart failure
• Present hepatocellular carcinoma and history of other cancers
• Severe anemia
• Advanced kidney disease
• Immunosuppressive therapy within 24 weeks prior to screening
• Alcohol or drug abuse within the 12 months prior to screening
• Trauma or surgical procedures requiring hospitalization within 8 weeks prior to Day 1
• Planned elective surgery during the study including 9 weeks following the final dose of study drug
• History of allergy against nucleoside analogs or human, humanized, chimeric, or murine monoclonal antibodies
• Inability to cooperate with study personnel or a history of noncompliance to the medical regimen (i.e., subjects who would be expected to comply poorly with the treatment)
• Clinically significant medical or psychiatric condition considered a high risk for participation in an investigational study
• Morbid obesity (body mass index [BMI] >40)
• Inadequate IV access