Status:
TERMINATED
A Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection
Lead Sponsor:
FibroGen
Conditions:
Liver Fibrosis Due to Chronic Hepatitis B Infection
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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. Th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT01217632
Start Date
August 1 2010
End Date
June 1 2015
Last Update
August 16 2016
Active Locations (9)
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1
Queen Mary Hospital
Pokfulam, Hong Kong Island, Hong Kong
2
Ruttonjee Hospital
Wan Chai, Hong Kong Island, Hong Kong
3
Princess Margaret Hospital
Kowloon, Kowloon, Hong Kong
4
Prince of Wales Hospital
Shatin, Kowloon, Hong Kong