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

This study is currently recruiting participants.
Verified January 2013 by FibroGen
Sponsor:
Information provided by (Responsible Party):
FibroGen
ClinicalTrials.gov Identifier:
NCT01217632
First received: September 30, 2010
Last updated: January 2, 2013
Last verified: January 2013
History of Changes

September 30, 2010
January 2, 2013
August 2010
December 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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: 3 weeks for 45 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01217632 on ClinicalTrials.gov Archive Site
To evaluate the safety, tolerability pharmacokinetic profiles of FG-3019 in the target population [ Time Frame: every 3 weeks for 45 weeks ] [ Designated as safety issue: Yes ]
To evaluate the safety, tolerability pharmacokinetic profiles of FG-3019 in the target population [ Time Frame: 3 weeks for 45 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Liver Fibrosis Due to Chronic Hepatitis B Infection
  • Drug: FG-3019
    FG-3019 at a dose of 15 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.
  • Placebo Comparator: FG-3019 Placebo
    Intervention: Drug: Placebo
  • Experimental: FG-3019
    FG-3019 at a dose of 15 mg/kg will be administered every 3 weeks by IV infusion in a total volume of at least 250 mL in normal saline.
    Intervention: Drug: FG-3019
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
228
December 2015
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Katharina Modelska, MD, PhD 415-978-1366 kmodelska@fibrogen.com
Hong Kong,   Thailand
 
NCT01217632
FGCL-3019-801
No
FibroGen
FibroGen
Not Provided
Study Chair: Katharina Modelska, MD, PhD FibroGen
Study Director: Karen Mosher FibroGen
FibroGen
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP