A Phase 2 interventional study of FG-3019 and Placebo in Liver Fibrosis Due to Chronic Hepatitis B Infection, sponsored by FibroGen. Terminated at 9 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-08-16.
Sponsored by FibroGen · Phase 2, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 114 is close to the median of 120 across 4,201 interventional studies indexed under Infections.
Browse Infections studies →FibroGen is the lead sponsor of 39 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 14 (100%) have results posted.
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Exclusion Criteria:
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.
Drug: Placebo · Drug: 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.
Drug: FG-3019 · Drug: 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.
Placebo will be administered every 3 weeks by intravenous (IV) infusion in a total volume of at least 250 mL in normal saline.
Also known as: Entecavir Dispersible (generic)
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
This study is terminated, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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FibroGen