Efficacy and Safety of Peginterferon a-2a in Patients of Chronic Hepatitis B With Spontaneous Decline of HBV DNA
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 第三阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
This study focused on the subsequential antiviral therapeutic strategies for chronic hepatitis B patients with spontaneous decline of HBV DNA after acute exacerbation. Patients fullfilled the following criterias were chosen for screening: They were antiviral treatment naı¨ve and had been positive for hepatitis B surface antigen (HBsAg) for at least 6 months, were positive for HBeAg and had an HBV DNA Level of more than 500,000IU/ml. Their serum alanine aminotransferase level was greater than 2 but less than or equal to 30 times the upper limit of the normal range, their peak value of total bililubin ranged from 2mg/ml to 20mg/ml and the prothrombin time activity was greater than 60%.
ALL of these patients were hospitalized and pretreated with anti-inflammation and liver protection agents such as Stronger Neo-Minophagen C, Polyunsaturated phosphatidylcholine (Essentiale), Ursodeoxycholic Acid and L-Glutathione reduced, without any nuclutide of nucleoside. Their ALT、TBIL and PTA were monitor weekly and HBVDNA level were measured every two weeks. Patients were eligible if their HBVDNA declined spontaneously by 2 log(10) IU/mL while their ALT falled below 10 ULN and TBIL falled below 2mg/ml within 8 weeks of pretreatment.
Patients with advanced fibrosis, cirrhosis and hepatoma were excluded. Other cause of chronic liver disease should be systematically checked to exclude co-infection with HDV, HCV and HIV, comorbidities with alcoholism, autoimmune and metabolic liver disease. Serious medical or psychiatric illnesses that had usage of corticosteroid or immunosup-pressive agents at the time of study were excluded. All patients in this study lived in Guangdong, a province of 100,000,000 populations, with same demographics. Owing to patients fear or refusal of liver biopsy, no patients had the liver biopsy and the rest relied on other clinical methods to obtain equivalent information of patient conditions. In our cases, ultrasonorgraphy helped to filter out patients with advanced fibrosis.The liver sonar examination was performed by two experi-enced hepatologists at least three times on each patient.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:180µg of peginterferon alfa-2a
Cases in group A receive 180µg of peginterferon alfa-2a (Pegasys,Roche) once weekly for 48 weeks.
|
180µg of peginterferon alfa-2a (Pegasys,Roche) once weekly for 48 weeks.
其他名称:
|
有源比较器:Entecavir
cases in group B received an continual entecavir therapy(0.5
mg orally once daily)
|
continual entecavir therapy(0.5
mg orally once daily)
|
无干预:Control group
Those in group C didn't accept any antiviral regiment .
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Complete viralogic response
大体时间:week 96
|
Complete viralogic response was defined as suppression of HBV DNA to the level below 60IU/mL(detected by Cobas Amplicor HBV Monitor Test, Roche Diagnostics).
|
week 96
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
HBsAg loss and seroconversion
大体时间:week 24,48,72 and 96
|
HBsAg loss was defined as HBsAg titre less than 0.05 IU/mL and the HBsAg seroconversion was defined as the loss of HBsAg and the presence of anti-HBs antibody.
HBeAg seroconversion was defined as disappearance of HBeAg and appearance of anti-HBe antibody, while HBeAg loss was defined as disappearance of HBeAg only.
|
week 24,48,72 and 96
|
ALT normalization
大体时间:week 24,48,72 and 96
|
ALT normalization was defined as ALT level less than 40 IU/L(determined by a sequential multiple autoanalyzer).
|
week 24,48,72 and 96
|
Sick leave in patients in different groups
大体时间:week 48,72 and 96
|
week 48,72 and 96
|
合作者和调查者
调查人员
- 学习椅:Gao Zhiliang, Doctor、The Third Affliated Hospital of Sun Yat-sen University
- 研究主任:Zhao Zhixin, Doctor、The Third Affliated Hospital of Sun Yat-sen University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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Pegasys(Roche)的临床试验
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National Institute of Diabetes and Digestive and...National Cancer Institute (NCI); National Institute of Allergy and Infectious Diseases (NIAID); National Institute on Minority Health and Health Disparities (NIMHD) 和其他合作者完全的
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Erasme University HospitalRoche Diagnostics; LHUB-ULB终止
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University of WashingtonNational Center for Advancing Translational Sciences (NCATS)邀请报名
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AeskuLab Pathology PragueInstitute of Biostatistics and analyses, Ltd.完全的
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Haukeland University HospitalSiemens Corporation, Corporate Technology招聘中
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National Taiwan University HospitalNational Science Council, Taiwan未知
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Foundation for Innovative New Diagnostics, SwitzerlandUniversity Hospital, Geneva; B.P. Koirala Institute of Health Sciences完全的
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National Taiwan University HospitalNational Science Council, Taiwan; Department of Health, Executive Yuan, R.O.C. (Taiwan)终止
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Hanyang University Seoul HospitalSeegene Medical Foundation完全的