MedTrace Logo

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

NCT01217632 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2016-08-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • FibroGen

    lead INDUSTRY

Principal Investigators

  • Frank Valone, MD · FibroGen

  • Mairead Carney · FibroGen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Hong Kong
  • Thailand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01217632 on ClinicalTrials.gov