NCT01997944已完成1 期
Phase Ib Study of Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein in Chronic Hepatitis B Patients
Beijing Bio-Fortune Ltd.1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2013年11月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of adverse events
研究概览
简要总结
This is an open label study that will be conducted at a single site in China to evaluate the safety,tolerability and PK/PD profile of multiple dose of recombinant human serum albumin/interferon alpha2a fusion protein in chronic hepatitis B patients.The total duration of study participation is up to 22 weeks for each subject,including 4 weeks screening period.
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 65 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
- •Chronic HBV infection (serum HBsAg detectable for > 6 months)
- •Serum HBeAg positive with HBV DNA >10^6copies/mL (or >20,000 IU/mL),orSerum HBeAg negative with HBV DNA >10^5copies/mL (or >2,000 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.
- •Interferon therapy or nucleotides analogues therapy in 6 months prior to entry.
- •Active lung disease or history of interstitial lung disease.
- •Hb< LLN or, and ANC < 750/mm3 or , and platelet count < 75,000 mm3 ,or WBC<3000/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 thyroid disease or current treatment for thyroid disease.
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Number of adverse events
时间窗: 18 weeks
次要结局
- Decrease of HBV DNA(18 weeks)
- AUCss(18 weeks)
- Css_av(18 weeks)
- Css-max(18 weeks)
- Tmax(18 weeks)
- Css_min(18 weeks)
- T1/2(18 weeks)
研究者
研究点 (1)
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