A Multi Center, Phase IIIb Study to Evaluate the Efficacy of Response Guided Therapy Using Quantitative HBsAg Measurement in Patient With HBeAg Positive Chronic Hepatitis B:
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- HBeAg seroconversion
研究概览
简要总结
Primary objective: Compare Pegasys RGT overall response rate (i.e., HBeAg seroconversion rate) with Pegasys mono historical response rate at week 72 (48 week treatment with 24 week follow up)
Secondary objective :
-
The changes of HBsAg titer
-
The rate of combined HBeAg seroconversion and HBV DNA < 300 copies/mL
-
The rate of serum HBV DNA < 300 copies/mL ⅳ. The rate of ALT normalization
-
The rate of HBsAg loss ⅵ. The rate of serum HBV DNA < 10,000 copies/mL
详细描述
After 12w treatment of Pegasys, depends on results of quantitative HBsAg test, Patients will be allocated to one of three groups.
- HBsAg >20,000 : study termination
- Group A :1,500<HBsAg≤ 20,000
- Group B : .HBsAg ≤ 1500 At week 48, according to HbeAg seroconversion, patients will be allocated to one of two sub-groups(A-1, A-2, B-1, B-2) Patients are seen for evaluation at treatment weeks 4,8,12,24,36,48. Post-treatment assessments will be performed at 4,12 and 24 week during off-treatment phase for the assessment of the primary and main secondary endpoints of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Age ≥ 18 years
- •Positive HBsAg for more than 6 months, positive HBeAg, detectable HBV DNA(patients must have > 100,000 copies/ml as measured by PCR) and anti-HBs negative
- •Elevated serum ALT > 2ULN but ≤ 10 × ULN as determined by two abnormal values taken ≥ 14 days apart during the six months before the first dose of study drug with at least one of the determinations obtained ≤ 35 days prior to the first dose.
排除标准
- •Patients must not have received antiviral therapy for their chronic hepatitis B. Patients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded. Exception: patients who have had less than 6 months treatment of NA(Nucleos(t)ide analog) and more than 1 year wash-out period for systemic antiviral therapy and negative results in the NA resistance test at baseline are not excluded.
- •Positive test at screening for HAV IgM Ab, HCV-RNA or HCV Ab, HDV Ab or HIV Ab.
- •Diagnosed hepatic cellular carcinoma
- •Any evidence of decompensated liver disease (Childs B-C)
研究组 & 干预措施
HBsAg quantification>20,000 IU/ml
stop peginterferon alfa 2a if patients reach HBsAg quantification>20,000 Iu/ml at 12w
干预措施: Peginterferon alfa-2a (Drug)
HBsAg<=1500IU/ml
extend peginterferon alfa 2a until 48weeks
干预措施: Peginterferon alfa-2a (Drug)
HBsAg >1500 <=20,000 IU/ML
add Entecavir for 12w with peginterferon alfa 2a then, extend peginterferon alfa 2a until 48w
干预措施: Peginterferon alfa-2a (Drug)
HBsAg >1500 <=20,000 IU/ML
add Entecavir for 12w with peginterferon alfa 2a then, extend peginterferon alfa 2a until 48w
干预措施: Entecavir (Drug)
结局指标
主要结局
HBeAg seroconversion
时间窗: 24 weeks post treatment follow up
次要结局
- The changes of HBsAg titer(baseline and 24weeks post treatment follow up)
研究者
Kwan Sik Lee
professor
Gangnam Severance Hospital