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

August 12, 2016 updated by: FibroGen

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Kowloon, Hong Kong
        • Princess Margaret Hospital
      • New Territories, Hong Kong
        • Tuen Mun Hospital
      • Tai Po, Hong Kong
        • Alice Ho Miu Ling Nethersole Hospital
    • Hong Kong Island
      • Pokfulam, Hong Kong Island, Hong Kong
        • Queen Mary Hospital
      • Wanchai, Hong Kong Island, Hong Kong
        • Ruttonjee Hospital
    • Kowloon
      • Shatin, Kowloon, Hong Kong
        • Prince of Wales Hospital
  • Thailand
    • Bangkok Noi
      • Siriaj, Bangkok Noi, Thailand, 10700
        • Siriraj Hospital
    • Chiang Mai
      • Amphur Muang, Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital
    • Songkla
      • Amphur Hatyai, Songkla, Thailand, 90110
        • Songklanagarind Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 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.
Drug: Entecavir
Other Names:
  • Entecavir Dispersible (generic)
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.
Experimental: 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: Entecavir
Other Names:
  • Entecavir Dispersible (generic)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: every 3 weeks for 45 weeks
every 3 weeks for 45 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FibroGen

Investigators

  • Study Chair: Frank Valone, MD, FibroGen
  • Study Director: Mairead Carney, FibroGen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 30, 2010

First Submitted That Met QC Criteria

October 7, 2010

First Posted (Estimate)

October 8, 2010

Study Record Updates

Last Update Posted (Estimate)

August 16, 2016

Last Update Submitted That Met QC Criteria

August 12, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FGCL-3019-801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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