Efficacy and Safety Study of Adefovir and Entecavir for Elderly With Chronic Hepatitis B
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- the rates of serum HBVDNA undetectable and Renal dysfunction
研究概览
简要总结
It is estimated that 350-400 million people have chronic infection with hepatitis B virus (HBV) all over the world. In china, 93 million individuals suffer from this chronic condition. Currently, seven medications are approved for the treatment of hepatitis B: two formulations of interferon and four nucleos(t)ide analogues. The Chinese population has one of the longer average life spans, and the size of the aged population has been increasing rapidly. As a result, the prevalence of elderly patients with HBV has increased, and the potential for development of cirrhosis or hepatocellular carcinoma in such patients is real. Hence, treatment of elderly patients with HBV is an important issue. However, ADV or ETV has become first choice due to the more side effect of INF and the resistant of LAM and LdT. But treatment outcomes with ADV and ETV in elderly are not known yet. In this study, we will evaluate and compare the efficacy and tolerability of ADV and ETV between younger and older patients with HBV. The aims of the present study are (1)to assess the benefits of ADV or ETV therapy for elderly patients with chronic hepatitis B, and (2)to determine differences in the emergence rate of side effect.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥18 years
- •HBsAg positive for more than 6 months before enrollment
- •Serum HBVDNA >2×104IU/ml and serum ALT >80U/L or TBIL < 34 umol/L for chronic hepatitis B
- •Serum ALT < 80U/L, but hepatic inflammation scores ≥ G2 or hepatic fibrosis stage ≥ S2 for chronic hepatitis B
- •Serum HBVDNA >40 IU/ml for cirrhosis regardless of ALT and TBIL
排除标准
- •Co-infected with HCV, HDV or HIV, or autoimmune liver diseases combined
- •received antiviral therapy or immunosuppressant drugs before 6 months prior to enrollment
- •Renal function: creatinine >1.5 ULN or eGFR< 50ml/min/1.73m2 before therapy
- •Combined with hepatocarcinoma before therapy
- •suspend therapy voluntarily
- •use other nephrotoxic drugs
研究组 & 干预措施
youth
<45years
Adefovir dipivoxil or Entecavir
Participants who received 10mg ADV more than 3 years or switch to other agent due to Renal dysfunction will be recruited.
Participants who received 0.5mg ETV more than 3 years will be recruited.
干预措施: Adefovir dipivoxil or Entecavir (Drug)
middle age
≥45years and<65years
Adefovir dipivoxil or Entecavir
Participants who received 10mg ADV more than 3 years or switch to other agent due to Renal dysfunction will be recruited.
Participants who received 0.5mg ETV more than 3 years will be recruited.
干预措施: Adefovir dipivoxil or Entecavir (Drug)
elderly
≥65 years
Adefovir dipivoxil or Entecavir
Participants who received 10mg ADV more than 3 years or switch to other agent due to Renal dysfunction will be recruited.
Participants who received 0.5mg ETV more than 3 years will be recruited.
干预措施: Adefovir dipivoxil or Entecavir (Drug)
结局指标
主要结局
the rates of serum HBVDNA undetectable and Renal dysfunction
时间窗: 3years
次要结局
- the rate of HBeAg seroconversion(at week 24、48、72、96、120、144)
- the rate of HBeAg negative(at week 24、48、72、96、120、144)
- the rate of normalisation of ALT(at week 2、4、12、24、36、48、60、72、84、96)
- the rate of HBsAg negative(at week48、96、144)
研究者
Ying-Jie Ji
MD
Beijing 302 Hospital