Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in HBeAg-positive and HBeAg-negative Chronic Hepatitis B
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 21
- 主要终点
- Percent of Participants With Hepatitis B Surface Antigen (HBsAg) Loss by Week 240
研究概览
简要总结
This clinical trial compares the efficacy of peginterferon plus tenofovir for 24 weeks followed by monotherapy with tenofovir for a further 3.5 years to the efficacy of tenofovir alone given for 4 years in patients with chronic hepatitis B. The primary measure of outcome will be HBsAg loss in serum at 48 weeks after stopping all antiviral therapy (sustained off-treatment response).
详细描述
The objective of this study is to compare the long-term efficacy of treatment with combination therapy with peginterferon plus tenofovir versus tenofovir monotherapy in the treatment of chronic hepatitis B.
This is a randomized (1:1) parallel group design trial comparing (i) tenofovir disoproxil fumarate (TDF) 300 mg daily for 192 weeks (4 years) and (ii) peginterferon alfa-2a 180 µg weekly for 24 weeks plus Tenofovir DF 300 mg daily for 192 weeks (4 years). Enrolled participants will be stratified by HBeAg status (positive/negative), genotype (A vs. all others) and cirrhosis (present vs. absent). After 192 weeks of treatment, participants meeting criteria for treatment discontinuation will stop treatment and be followed for 48 weeks (total duration of treatment and follow up is 240 weeks). Emtricitabine/tenofovir coformulated as Truvada, approved for treatment of HIV but not for treatment of hepatitis B virus (HBV) infection, will be offered to patients with primary nonresponse, partial virological response or confirmed virologic breakthrough.
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 —（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
- 未提供
研究组 & 干预措施
Tenofovir
Tenofovir 192 weeks
干预措施: Tenofovir (Drug)
Peginterferon-alfa 2a and tenofovir
A combination of peginterferon-alfa 2a plus tenofovir for 24 weeks and then tenofovir only for 168 weeks
干预措施: Peginterferon-alfa 2a and tenofovir (Drug)
结局指标
主要结局
Percent of Participants With Hepatitis B Surface Antigen (HBsAg) Loss by Week 240
时间窗: Week 240
Estimated percent of participants who became HBsAg negative by week 240 from randomization
次要结局
- Cumulative Percent of Participants With HBsAg Loss at Week 192(Week 192)
- Number of Participants With Adverse Events(up to 240 weeks)
- Number of Participants With HBeAg Seroconversion at Week 192(week 192)
- Absence of Detectable Antiviral Drug-Resistant HBV Mutations at Week 192(week 192)
- Cumulative Percent of Participants With HBsAg Loss at Week 240(Week 240)
- Number of Participants With Serious Adverse Events(Up to 240 weeks)
- Number of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 192(week 192)
- Number of Participants With HBV DNA<1000 IU/mL at Week 240(week 240)
- Number of Participants With Alanine Transaminase(ALT) Levels <= 38 U/L for Males and <=25 for Females at Week 192(week 192)
- Number of Participants With HBsAg Seroconversion at Week 192(week 192)
- Number of Participants With Normal Alanine Transaminase (ALT) Levels at Week 240(week 240)
- Number of Participants With HBeAg Loss at Week 240(week 240)
- Number of Participants With HBeAg Seroconversion at Week 240(week 240)
- Number of Participants With Normal Alanine Transaminase (ALT) Levels at Week 192(week 192)
- Number of Participants With HBV DNA<1000 IU/mL at Week 192(week 192)
- Number of Participants With HBsAg Seroconversion at Week 240(week 240)
- Number of Participants With HBV DNA<20 IU/mL at Week 192(week 192)
- Number of Participants With HBV DNA<20 IU/mL at Week 240(week 240)