NCT01217632

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Kyntra Bio · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Fibrosis Due to Chronic Hepatitis B Infection

Interventions

Type	Name	Description
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.
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.
DRUG	Entecavir

Timeline

• Start date: 2010-08-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2010-10-08
• Last updated: 2016-08-16

Locations

9 sites across 2 countries: Hong Kong, Thailand