drugset / Trial / NCT01217632

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

NCT01217632

Phase 2 Terminated 114 enrolled Kyntra Bio
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2010-08
Primary completion
2015-06
Completion
2015-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Pamrevlumab Monoclonal antibody 15 mg/kg Intravenous
Subject Pamrevlumab Monoclonal antibody 45 mg/kg Intravenous
Background Entecavir Small molecule