Study on Optimized Treatment of Peginterferon Alfa 2a or 2b in Anti-virus Treatment Naive Patients With Hepatitis b Virus Related Liver Fibrosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change of level of liver fibrosis after anti-virus treatment
研究概览
简要总结
Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. We design this study to investigate treatment of peginterferon alfa 2a/2b in anti-virus treatment naive patients with HBV related liver fibrosis.
详细描述
Compared to nucleoside/nucleotide analogues, peginterferon alfa 2a/2b may has more therapeutic efficacy in hepatitis B surface antigen or e antigen seroconversion and anti-tumor occurrence in chronic hepatitis b patients. But there still lacks of studies on peginterferon alfa 2a or 2b treatment in patients with HBV related liver fibrosis. We design this study to investigate optimized treatment of peginterferon alfa 2a/2b, comparing to nucleoside/nucleotide analogues, in anti-virus treatment naive patients with HBV related liver fibrosis.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;
- •Age from 18 to 55 years old;
- •Fibrosis lever of F1 to F3 from liver biopsy; if liver biopsy unreachable, fibrosis lever of 7 to 14 kpa from fibroscan;
- •Portal vein diameter ≤ 12 mm from liver ultrasound;
- •Without treatment of anti-virus treatment ever before.
排除标准
- •Decompensated cirrhosis, hepatocellular carcinoma or other malignancy;
- •Pregnancy or lactation;
- •Other active liver diseases；
- •Human immunodeficiency virus infection or congenital immune deficiency diseases;
- •Severe diabetes, autoimmune diseases;
- •Other important organ dysfunctions;
- •Patients can not follow-up.
研究组 & 干预措施
TDF group
80 patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from baseline to 144 weeks.
干预措施: Tenofovir Disoproxil Fumarate (Drug)
Peginterferon alfa group
40 patients would receive treatment of subcutaneous injection of peginterferon alfa 2a 180 μg or peginterferon alfa 2b 80μg once per week from baseline to 48 weeks. Then they would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from 49 to 144 weeks.
干预措施: Peginterferon Alfa-2a (Drug)
Peginterferon alfa group
40 patients would receive treatment of subcutaneous injection of peginterferon alfa 2a 180 μg or peginterferon alfa 2b 80μg once per week from baseline to 48 weeks. Then they would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day from 49 to 144 weeks.
干预措施: Peginterferon Alfa-2b (Drug)
结局指标
主要结局
Change of level of liver fibrosis after anti-virus treatment
时间窗: 48 week, 144 week
Liver biopsy or fibroscan would be accessed to know the change of level of liver fibrosis at 48 and 144 weeks after anti-virus treatment.
次要结局
- Ratio of patients with undetectable hepatitis b virus DNA after anti-virus treatment(24 week, 48 week, 72 week, 96 week, 120 week,144 week)
- Ratio of patients with hepatitis B e antigen seroconversion after anti-virus treatment(24 week, 48 week, 72 week, 96 week, 120 week,144 week)
- Ratio of patients with hepatitis b surface antigen seroconversion after anti-virus treatment(24 week, 48 week, 72 week, 96 week, 120 week,144 week)
研究者
Liang Peng
Professor
Third Affiliated Hospital, Sun Yat-Sen University