TDF Combined With LDT for the Treatment of HBeAg-positive Hepatitis B Patients With Poor Response to TDF for Twelve Months
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- HBeAg seroconversion rates
研究概览
简要总结
Studies have shown that the HBeAg seroconversion rate of HBeAg positive chronic hepatitis B with tenofovir for one year's treatment was 17.8% and the negative conversion rate of their HBeAg and HBV DNA were 20.0% and 97.6%. The HBeAg Seroconversion rate of these patients was lower.Clinically, most patients need to take tenofovir for a long time, which may cause serious complications such as renal function damage,with decreased therapy compliance and Increased cost of treatment.In the course of tenofovir treatment, it is common that HBV-DNA negative patients with HBeAg Being down poor or staying at a low positive level for a long time keep taking the medicine. Therefore, it is Significant to Increase the HBeAg seroconversion rate of tenofovir during the clinical treatment.
Telbivudine has a strong antiviral effect.Studies have shown that the HBeAg seroconversion rate of HBeAg positive CHB for one year was 25%, which was higher than other nucleosides, and it could also improve the damaged renal function to a certain extent.The HBeAg seroconversion rate of patients with poor response to tenofovir for 12 months could be still poor if for 24 months . Therefore, this study is to observe the efficacy of these patients combined with telbivudine.
详细描述
This is an open, multicenter, exploratory and real-world clinical study. It will be carried out in patients with poor response (HBV DNA > 2x103iu / ml) to tenofovir for 12 months. After one -week screening period, patients will be randomly assigned 1:1 to control and experimental groups. The control group takes tenofovir for 12 months while the experimental group takes tenofovir combined with telbivudinefor 12months .
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Co-infectious with hepatitis A, hepatitis C, hepatitis D, hepatitis E or HIV;
- •In the decompensated stage of liver cirrhosis, such as ascites, varicose bleeding or hepatic encephalopathy;
- •With malignant tumors (including hepatocellular carcinoma);
- •Concomitant with other liver diseases, such as alcoholic liver disease, autoimmune disease, or other systemic diseases involving the liver, such as hemochromatosis, Alpha-1 antitrypsin deficiency, or Wilson disease;
- •During the study period, chronic systemic steroid drugs are required or may be used under any medical conditions;
- •There are any other factors that the researcher thinks are not suitable for inclusion in the study, or that may affect the patient's participation or completion of the study.
研究组 & 干预措施
Active comparator:person with TDF
TDF monotherapy was continued for 12 months
干预措施: Tenofovir Disoproxil Fumarate 300 MG (Drug)
Experimental:person with TDF+LDT
TDF combined with LDT for 12 months
干预措施: TDF (Drug)
结局指标
主要结局
HBeAg seroconversion rates
时间窗: 24months
HBeAg seroconversion rates at 24 months after tenofovir plus telbivudine treatment
次要结局
- HBeAg negative rate(12 and 24months)
- Renal function index(12 and 24months)
- ALT normalization rate(12 and 24months)
研究者
Chaoshuang Lin
Professor Lin
Third Affiliated Hospital, Sun Yat-Sen University