Overview

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

Status:
Terminated
Trial end date:
2015-06-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
FibroGen
Treatments:
Antibodies, Monoclonal
Entecavir
Criteria
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