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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2015-06-30

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.

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Detailed Description

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Conditions

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Liver Fibrosis Due to Chronic Hepatitis B Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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FG-3019 Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered every 3 weeks by intravenous (IV) infusion in a total volume of at least 250 mL in normal saline.

Entecavir

Intervention Type DRUG

FG-3019

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.

Group Type EXPERIMENTAL

FG-3019

Intervention Type DRUG

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.

Entecavir

Intervention Type DRUG

Interventions

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FG-3019

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.

Intervention Type DRUG

Placebo

Placebo will be administered every 3 weeks by intravenous (IV) infusion in a total volume of at least 250 mL in normal saline.

Intervention Type DRUG

Entecavir

Intervention Type DRUG

Other Intervention Names

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Entecavir Dispersible (generic)

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No