Observation Study of Different Optimized Therapy Method of Patients With Chronic Hepatitis B
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- HBeAg seroconversion rate
研究概览
简要总结
Along with the improvement of the accuracy of detection of HBV serological markers, the optimization of antiviral therapy for patients with chronic hepatitis B (CHB) infection becomes feasible. Currently, the recommendation of optimized treatment especially interferon therapy are mainly based on retrospective studies, it still lacks prospective evidence. This study is aimed to evaluate the efficacy, safety and pharmacoeconomics benefits of 48 weeks optimized interferon therapy (switch to telbivudine or plus adefovir dipivoxil) for HBeAg positive CHB with inadequate response to 24 weeks interferon treatment.
详细描述
Patients with inadequate response to interferon therapy at 24 weeks were enrolled in this study and accepted the optimized therapy (add on ADV or switch to LDT) for 48weeks. All these patients were followed for 48 weeks and the HBeAg seroconversion and HBV DNA level were observed. Safety and the economic effect of the two optimized therapy methods also were observed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients receiving Peg interferon α-2a with inadequate response at 24 weeks (HBeAg titer ≥ 100Paul Ehrlich Institute Unit (PEIU)/ml and HBV DNA ≥ 5.0 Log copies/ml or HBV DNA titer decline <1 Log copies/ml) were enrolled into this study.
排除标准
- •no decompensated cirrhosis,
- •no hepatitis C, hepatitis D or human immunodeficiency virus (HIV) co-infection,
- •no hepatocellular carcinoma and other tumors or history of severe hepatitis,
- •no other systems diseases, such as a history of cardiopulmonary diseases, thyroid disorders, immune system disorders, epilepsy or mental illness (such as severe depression).
研究组 & 干预措施
Add on ADV
Patients with inadequate response to interferon at 24 weeks received interferon add on ADV optimized therapy
干预措施: Interferon Alfa-2a add on ADV (Drug)
Switch to LDT
Patients with inadequate response to interferon at 24 weeks received switching to LDT therapy
干预措施: Interferon Alfa-2a add on ADV (Drug)
结局指标
主要结局
HBeAg seroconversion rate
时间窗: 48weeks
次要结局
- HBV DNA decline(48weeks)
研究者
LiangXS
Assistant Professor
Changhai Hospital