A Prospective Randomized Controlled Study to Compare the Efficacy of Combined Tenofovir Plus Telbuvidine vs Tenofovir Alone in Patients With Spontaneous Reactivation of Hepatitis B.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
The relevant data will be prospectively collected included patient demographics, clinical, all laboratory variables including virological tests, genotyping by direct sequencing, abdominal ultrasound, and upper gastrointestinal (GI) endoscopy. Trans jugular liver biopsy (TJLB) and hepatic venous pressure gradient (HVPG) will be done in patients when it was not evident whether the underlying liver disease was chronic based on clinical, biochemical, radiological investigations, and upper GI endoscopy. Severity of the liver disease will be assessed by Child-Turcotte Pugh score (CTP) and model for end stage liver disease (MELD) score.
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
- •Reactivation of CHB characterized by a rise in ALT level >5 times upper limit of normal along with HBV DNA level >10^5 copies/ mL (> 1.8 X 10^4 IU/mL).
排除标准
- •Superinfection with other viruses (hepatitis E, A, D, or C)
- •other causes of chronic liver failure
- •coexistent hepatocellular carcinoma (HCC)
- •portal vein thrombosis
- •coexistent renal impairment
- •coinfection with human immunodeficiency virus (HIV)
- •patients who had received a previous course of any antiviral, immunomodulator or cytotoxic/immunosuppressive therapy for chronic hepatitis or other illness within at least the preceding 12 months.
研究组 & 干预措施
Tenofovir + Telbivudine
Tenofovir (300 mg/day) plus telbivudine (600 mg/day).
干预措施: Tenofovir (Drug)
Tenofovir
In tenofovir arm subjects will receive tenofovir (300 mg) once daily.
干预措施: Tenofovir + Telbivudine (Drug)
结局指标
主要结局
Survival
时间窗: 1 and 3 months
次要结局
- Alteration of renal functions(1 and 3 months)
- Reduction in HBV DNA.(7 days, 15 days, 1 month and 3 month)
- Drug(s) related adverse effects/ side effects(1 and 3 months)
- Improvement in CTP and MELD scores(1 and 3 months)