NCT01220596Unknown3 期
A Randomized, Multi Center, Phase IIIb Open-label Study to Evaluate the Efficacy of Sequential Therapy of Peginterferon Alfa-2a(Pegasys(TM)) Following Entercavir Compared With Peginterferon Alfa-2a Monotherapy in Patient With HBeAg Positive Chronic Hepatitis B.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 228
- 试验地点
- 20
- 主要终点
- HBeAg seroconversion
研究概览
简要总结
Evaluate the safety and efficacy of Peginterferon alfa-2a following Entecavir compared with Peginterferon alfa-2a monotherapy in patient with HBeAg positive chronic hepatitis B.
- Increased HBeAg seroconversion rate
- Increased HBsAg loss rate
- To define the best treatment condition for chronic HBV hepatitis patients
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
- •Chronic hepatitis B patients with HBeAg positive, HBsAg positive, HBV DNA > 100,000 copies/ml and anti-HBs negative, serum ALT exceeding 2 X ULN but less than 10 X ULN.
排除标准
- •Patient infected concurrently with HCV, HDV and HIV or patient with a history of antiviral treatment for Hepatitis B or patient with hepatic decompensation.
研究组 & 干预措施
Sequential therapy
Experimental
Entecavir/Baraclude(TM), 0.5mg, oral administration, once daily, for the first 12 weeks Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, from week 4 to 52 for 48 weeks
干预措施: Entecavir and Pegylated interferon α-2a Sequential Treatment Group (Drug)
Peginterferon alfa-2a monotherapy
Active Comparator
Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks
干预措施: Pegylated interferon α-2a Monotreatment Group (Drug)
结局指标
主要结局
HBeAg seroconversion
时间窗: 24 weeks after treatment
次要结局
- the change of HBsAg titer(24 weeks after treatment)
- the rate of combined HBeAg seroconversion and HBV DNA < 300 copies/ml(24 weeks after treatment)
- The rate of serum HBV DNA < 300 copies(24 weeks after treatment)
- The rate of ALT normalization(24 weeks after treatment)
- The rate of HBsAg loss(24 weeks after treatment)
研究者
研究点 (20)
Loading locations...
相似试验
Unknown
3 期
HRN 004- Peginterferon a-2a Plus Ribavirin for Chronic Hepatitis C Infection in HIV Infected Persons Who Have Failed to Achieve a Sustained Virologic Response Following Previous Interferon TherapyChronic Hepatitis C Infection in HIV Infected PersonsHIV InfectionsNCT00215839Hepatitis Resource Network
已完成
4 期
A Study of Combination Treatment With Peginterferon Alfa-2a (Pegasys) Plus Ribavirin (Copegus) in Participants With Chronic Hepatitis CHepatitis C, ChronicNCT00800748Hoffmann-La Roche372
终止
1 期
A Study of Pegylated Interferon Alfa-2b (MK-4031) as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (MK-4031-370)Malignant MelanomaNCT01636960Merck Sharp & Dohme LLC9
已完成
不适用
An Observational Study of Peginterferon Alfa-2a in Combination With Ribavirin in Participants With Chronic Hepatitis C and Compensated Liver CirrhosisHepatitis C, ChronicNCT01609049Hoffmann-La Roche1,496
已完成
3 期
Efficacy and Safety of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis BChronic Hepatitis BNCT01760122Xiamen Amoytop Biotech Co., Ltd.820