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

FibroGen

Status and phase: Terminated; Phase 2

Conditions: Liver Fibrosis Due to Chronic Hepatitis B Infection

Treatments: Drug: Placebo; Drug: FG-3019; Drug: Entecavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01217632

FGCL-3019-801

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 2 patient groups, including a placebo group

FG-3019 Placebo

Placebo Comparator group

Description:

Placebo will be administered at 15-45 mg/kg every 3 weeks by IV infusion in a total volume of at least 250 mL in normal saline.

Treatment:

Drug: Placebo

Drug: Entecavir

FG-3019

Experimental group

Description:

FG-3019 at a dose of 15-45 mg/kg will be administered every 3 weeks by IV infusion in a total volume of at least 250 mL in normal saline.

Treatment:

Drug: FG-3019

Drug: Entecavir