Liver Fibrosis Due to Chronic Hepatitis B Infection
Conditions
Keywords
Connective tissue growth factor (CTGF), human IgG1 monoclonal antibody
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.
Interventions
DRUGFG-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.
DRUGPlacebo
Placebo will be administered every 3 weeks by intravenous (IV) infusion in a total volume of at least 250 mL in normal saline.
DRUGEntecavir
Sponsors
Kyntra Bio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To evaluate the safety, tolerability pharmacokinetic profiles of FG-3019 in the target population | every 3 weeks for 45 weeks |
Countries
Hong Kong, Thailand
Outcome results
None listed