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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. (see Contacts and Locations)
Verified August 2014 by FibroGen
Sponsor:
Information provided by (Responsible Party):
FibroGen
ClinicalTrials.gov Identifier:
NCT01217632
First received: September 30, 2010
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Liver Fibrosis Due to Chronic Hepatitis B Infection
Drug: FG-3019
Drug: Placebo
Drug: Entecavir
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection

Resource links provided by NLM:


Further study details as provided by FibroGen:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 228
Study Start Date: August 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: FG-3019 Placebo 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
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: 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01217632

Contacts
Contact: Mairead Carney 415-978-1337 mcarney@fibrogen.com
Contact: Jill Magadia 415-978-1340 jmagadia@fibrogen.com

Locations
Hong Kong
Queen Mary Hospital Recruiting
Pokfulam, Hong Kong Island, Hong Kong
Ruttonjee Hospital Terminated
Wanchai, Hong Kong Island, Hong Kong
Prince of Wales Hospital Recruiting
Shatin, Kowloon, Hong Kong
Princess Margaret Hospital Recruiting
Kowloon, Hong Kong
Tuen Mun Hospital Recruiting
New Territories, Hong Kong
Alice Ho Miu Ling Nethersole Hospital Recruiting
Tai Po, Hong Kong
Thailand
Siriraj Hospital Recruiting
Siriaj, Bangkok Noi, Thailand, 10700
Maharaj Nakorn Chiang Mai Hospital Recruiting
Amphur Muang, Chiang Mai, Thailand, 50200
Songklanagarind Hospital Recruiting
Amphur Hatyai, Songkla, Thailand, 90110
Sponsors and Collaborators
FibroGen
Investigators
Study Chair: Frank Valone, MD FibroGen
Study Director: Mairead Carney FibroGen
  More Information

No publications provided

Responsible Party: FibroGen
ClinicalTrials.gov Identifier: NCT01217632     History of Changes
Other Study ID Numbers: FGCL-3019-801
Study First Received: September 30, 2010
Last Updated: August 4, 2014
Health Authority: Hong Kong: Department of Health

Keywords provided by FibroGen:
Connective tissue growth factor (CTGF)
human IgG1 monoclonal antibody

Additional relevant MeSH terms:
Communicable Diseases
Fibrosis
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Infection
Liver Cirrhosis
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Pathologic Processes
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 19, 2014