Liver Fibrosis Due to Chronic Hepatitis B Infection Clinical Trial
Official title:
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study of FG-3019 in Subjects With Liver Fibrosis Due to Chronic Hepatitis B Infection
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.
| Status | Terminated |
| Enrollment | 114 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Hong Kong | Princess Margaret Hospital | Kowloon | |
| Hong Kong | Tuen Mun Hospital | New Territories | |
| Hong Kong | Queen Mary Hospital | Pokfulam | Hong Kong Island |
| Hong Kong | Prince of Wales Hospital | Shatin | Kowloon |
| Hong Kong | Alice Ho Miu Ling Nethersole Hospital | Tai Po | |
| Hong Kong | Ruttonjee Hospital | Wanchai | Hong Kong Island |
| Thailand | Songklanagarind Hospital | Amphur Hatyai | Songkla |
| Thailand | Maharaj Nakorn Chiang Mai Hospital | Amphur Muang | Chiang Mai |
| Thailand | Siriraj Hospital | Siriaj | Bangkok Noi |
| Lead Sponsor | Collaborator |
|---|---|
| FibroGen |
Hong Kong, Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | To evaluate the safety, tolerability pharmacokinetic profiles of FG-3019 in the target population | every 3 weeks for 45 weeks | Yes |