A Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection
- Conditions
- Liver Fibrosis Due to Chronic Hepatitis B Infection
- Interventions
- Registration Number
- NCT01217632
- Lead Sponsor
- FibroGen
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 114
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FG-3019 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. FG-3019 Placebo Placebo 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 Entecavir 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. FG-3019 Placebo Entecavir 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.
- Primary Outcome Measures
Name Time Method 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 every 3 weeks for 45 weeks
- Secondary Outcome Measures
Name Time Method To evaluate the safety, tolerability pharmacokinetic profiles of FG-3019 in the target population every 3 weeks for 45 weeks
Trial Locations
- Locations (9)
Ruttonjee Hospital
🇭🇰Wanchai, Hong Kong Island, Hong Kong
Siriraj Hospital
🇹🇭Siriaj, Bangkok Noi, Thailand
Maharaj Nakorn Chiang Mai Hospital
🇹🇭Amphur Muang, Chiang Mai, Thailand
Songklanagarind Hospital
🇹🇭Amphur Hatyai, Songkla, Thailand
Queen Mary Hospital
🇭🇰Pokfulam, Hong Kong Island, Hong Kong
Princess Margaret Hospital
🇭🇰Kowloon, Hong Kong
Prince of Wales Hospital
🇭🇰Shatin, Kowloon, Hong Kong
Tuen Mun Hospital
🇭🇰New Territories, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
🇭🇰Tai Po, Hong Kong