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

Primary Purpose

Liver Fibrosis Due to Chronic Hepatitis B Infection

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
FG-3019
Placebo
Entecavir
Sponsored by
FibroGen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Fibrosis Due to Chronic Hepatitis B Infection focused on measuring Connective tissue growth factor (CTGF), human IgG1 monoclonal antibody

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Queen Mary Hospital
  • Ruttonjee Hospital
  • Prince of Wales Hospital
  • Princess Margaret Hospital
  • Tuen Mun Hospital
  • Alice Ho Miu Ling Nethersole Hospital
  • Siriraj Hospital
  • Maharaj Nakorn Chiang Mai Hospital
  • Songklanagarind Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

FG-3019 Placebo

FG-3019

Arm Description

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.

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.

Outcomes

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

Secondary Outcome Measures

To evaluate the safety, tolerability pharmacokinetic profiles of FG-3019 in the target population

Full Information

First Posted
September 30, 2010
Last Updated
August 12, 2016
Sponsor
FibroGen
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1. Study Identification

Unique Protocol Identification Number
NCT01217632
Brief Title
A Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to an unexpected prominent effect of entecavir alone in this patient population.
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FibroGen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Fibrosis Due to Chronic Hepatitis B Infection
Keywords
Connective tissue growth factor (CTGF), human IgG1 monoclonal antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FG-3019 Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
FG-3019
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
FG-3019
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered every 3 weeks by intravenous (IV) infusion in a total volume of at least 250 mL in normal saline.
Intervention Type
Drug
Intervention Name(s)
Entecavir
Other Intervention Name(s)
Entecavir Dispersible (generic)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To evaluate the safety, tolerability pharmacokinetic profiles of FG-3019 in the target population
Time Frame
every 3 weeks for 45 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Valone, MD
Organizational Affiliation
FibroGen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mairead Carney
Organizational Affiliation
FibroGen
Official's Role
Study Director
Facility Information:
Facility Name
Queen Mary Hospital
City
Pokfulam
State/Province
Hong Kong Island
Country
Hong Kong
Facility Name
Ruttonjee Hospital
City
Wanchai
State/Province
Hong Kong Island
Country
Hong Kong
Facility Name
Prince of Wales Hospital
City
Shatin
State/Province
Kowloon
Country
Hong Kong
Facility Name
Princess Margaret Hospital
City
Kowloon
Country
Hong Kong
Facility Name
Tuen Mun Hospital
City
New Territories
Country
Hong Kong
Facility Name
Alice Ho Miu Ling Nethersole Hospital
City
Tai Po
Country
Hong Kong
Facility Name
Siriraj Hospital
City
Siriaj
State/Province
Bangkok Noi
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai Hospital
City
Amphur Muang
State/Province
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Songklanagarind Hospital
City
Amphur Hatyai
State/Province
Songkla
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

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

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