A Pharmacokinetic/Pharmacodynamic Evaluation of ABF656 in Subjects With Chronic Hepatitis B, e Ag+, Infection.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Evaluate the safety, tolerability and pharmacodynamic effect of various doses of albinterferon alfa-2b in hepatitis B patients on seroconversion of hepatitis markers. Measure: Clinical laboratory. HBV DNA level and HBeAg seroconversion rate.
研究概览
简要总结
This study will assess the efficacy of ABF656 in chronic hepatitis B characterized by HBeAg positivity. The study is designed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase 3 trials. The trial is also designed to generate the PK data in hepatitis B patients to satisfy regulatory requirements in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-75 years of either non-child bearing potential or if of child bearing potential on two adequate forms of birth control
- •Chronic HBV infection (serum HBsAg detectable for > 6 months)
- •Serum HBeAg positive with HBV DNA >106copies/mL (or >200,000 IU/mL)
- •Serum ALT must be > 2 x ULN but below 10 x ULN
排除标准
- •Steroid treatment or immunosuppression 3 months prior to entry.
- •Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
- •Hb< 10g/dL or, and ANC < 750/mm3 or , and platelet count < 75,000 mm3 .
- •Significant chronic medical conditions other than chronic hepatitis B which in the opinion of the investigator preclude enrollment into the study.
- •Evidence of hepatic decompensation (i.e., Child-Pugh score of B or C).
- •Seropositive for HIV, HCV, or HDV (Hepatitis Delta virus).
- •History of hypothyroidism or current treatment for thyroid disease.
- •Patients with treated or untreated malignancy of any organs, with the exception of localized basal cell carcinoma
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Group 4 ABF656 1500ug Q4w
干预措施: albinterferon alfa-2b (Drug)
Group 5 Pegasys® 180µg qw
干预措施: Pegasys® (Drug)
Group 1 ABF656 900ug Q2w
干预措施: albinterferon alfa-2b (Drug)
Group 2 ABF656 900ug Q4w
干预措施: albinterferon alfa-2b (Drug)
Group 3 AB656 1200ug Q4w
干预措施: albinterferon alfa-2b (Drug)
结局指标
主要结局
Evaluate the safety, tolerability and pharmacodynamic effect of various doses of albinterferon alfa-2b in hepatitis B patients on seroconversion of hepatitis markers. Measure: Clinical laboratory. HBV DNA level and HBeAg seroconversion rate.
时间窗: 48 weeks
次要结局
- Evaluate the pharmacokinetics at different doses of albinterferon alfa-2b in patients with chronic hepatitis B infection. Measure: Serum concentration of albinterferon alfa-2b(up to 12 weeks)