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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
114
Queen Mary Hospital
Pokfulam, Hong Kong Island, Hong Kong
Ruttonjee Hospital
Wan Chai, Hong Kong Island, Hong Kong
Princess Margaret Hospital
Kowloon, Kowloon, Hong Kong
Prince of Wales Hospital
Shatin, Kowloon, Hong Kong
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
To evaluate the safety, tolerability pharmacokinetic profiles of FG-3019 in the target population
Time frame: every 3 weeks for 45 weeks
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Tuen Mun Hospital
New Territories, New Territories, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Tai Po, Hong Kong
Siriraj Hospital
Siriaj, Bangkok Noi, Thailand
Songklanagarind Hospital
Amphur Hatyai, Changwat Songkhla, Thailand
Maharaj Nakorn Chiang Mai Hospital
Amphur Muang, Chiang Mai, Thailand