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

Study Overview
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Brief Summary
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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.

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

Conditions
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Liver Fibrosis Due to Chronic Hepatitis B Infection

Intervention / Treatment
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* Drug: FG-3019
* Drug: Placebo
* Drug: Entecavir


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: FG-3019 Placebo<br>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. | Drug: Placebo<br>* Placebo will be administered every 3 weeks by intravenous (IV) infusion in a total volume of at least 250 mL in normal saline.<br>Drug: Entecavir<br> <br> * Other names: Entecavir Dispersible (generic);|
| Experimental: FG-3019<br>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. | Drug: FG-3019<br>* 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.<br>Drug: Entecavir<br> <br> * Other names: Entecavir Dispersible (generic);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy of FG-3019 administered every 3 weeks for 45 weeks on liver fibrosis in subjects with chronic active hepatitis B infection on entecavir therapy |  | every 3 weeks for 45 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety, tolerability pharmacokinetic profiles of FG-3019 in the target population |  | every 3 weeks for 45 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Connective tissue growth factor (CTGF), human IgG1 monoclonal antibody