A Randomised Trial Comparing Entacavir and Tenofovir in Patients With HBV Decompensated Cirrhosis
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Safety and efficacy
研究概览
简要总结
Entacavir and tenofovir are two first line therapies for chronic hepatitis B. Both agents have been claimed equivalent in treatment, there are no head to head trials available in the literature about there effectiveness in HBV Decompensated Cirrhosis. The investigators aimed to compare safety/efficacy and virological response in patients with HBV Decompensated Cirrhosis.
详细描述
The effectiveness of entacavir and tenofovir has not been prospectively studied in HBV Decompensated cirrhosis? This prospective, randomised clinical trial will help us in better patient management more efficacy and cost effectiveness.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age (18 years- 70 years)
- •Hbv surface antigen positive > 6 months
- •HbeAg (positive or negative both)
- •Hbv DNA 10^3
- •No evidence of HCC
- •Platelets count > 30 thousands
- •CTP score > 7
- •Hepatic encephalopathy (grade 1 - 2 only)
- •No prior Drug resistance
排除标准
- •Age < 18 years
- •HCC patients
- •Prior drug resistance
- •Current HE > 2
- •Solid organ transplantation
- •Inadequate hematological function
- •Co infection with hepatitis C and HIV
- •Autoimmune disorders
- •Pregnancy and Breast feeding
- •Other hepatic diseases
- •Patients on immunosuppressant or chemotherapy agents
研究组 & 干预措施
Entacavir
Entacavir 0.5 mg (OD) for 48 weeks
干预措施: Entacavir (Drug)
Entacavir
Entacavir 0.5 mg (OD) for 48 weeks
干预措施: Tenofovir (Drug)
Tenofovir
Tenofovir 300 mg ,OD for 48 weeks
干预措施: Entacavir (Drug)
Tenofovir
Tenofovir 300 mg ,OD for 48 weeks
干预措施: Tenofovir (Drug)
结局指标
主要结局
Safety and efficacy
时间窗: 48 weeks
EFFICACY ENDPOINTS: EFFICACY ENDPOINTS INCLUDED PLASMA HBV DNA, ALT, HBEAG, HBSAG LOSS AND SEROCONVERION AS WELL AS CTP AND MELD SCORE.
次要结局
- Safety(48 weeks)
研究者
Mohammad sadik memon
Professor of gastroenterology
Asian Institute Of Medical Sciences