A Study of Peginterferon Alfa-2a (40KD) (PEGASYS®) in Participants With Hepatitis B Envelope Antigen (HBeAg) - Positive Chronic Hepatitis B
2016年8月31日 更新者：Hoffmann-La Roche
Baltic Post-marketing Program of PEGASYS (Peg Interferon Alpha-2a 40KD) in Patients With HBeAg-positive and HBeAg-negative Chronic Hepatitis B
This single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in treatment-naive Baltic participants with Hepatitis B envelope antigen (HBeAg)-positive chronic Hepatitis B virus (HBV).
All participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneously once weekly.
Following 48 weeks of treatment, there will be a 24 week period of treatment-free follow-up.
The anticipated time on study treatment is 3-12 months, and the target sample size is less than 100 participants.
研究概览
研究类型
介入性
注册 (实际的)
39
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adult participants, 18-70 years of age;
- HBeAg positive, Hepatitis B surface antigen (HBsAg) positive for greater than or equal to 6 months;
- anti-HBs negative;
- Hepatitis B virus deoxyribonucleic acid (HBV DNA) greater than 5,00,000 copies/milliliters.
Exclusion Criteria:
- Previous antiviral or interferon-based therapy for chronic hepatitis B;
- Evidence of decompensated liver disease;
- Chronic liver disease other than viral hepatitis;
- Co-infection with active hepatitis A, C or D virus;
- Co-infection with human immunodeficiency virus.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 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：Peginterferon Alfa-2a
Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
|
180 mcg subcutaneously once per week for 48 weeks.
其他名称：
|
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 |
|---|---|---|
|
Number of Hepatitis B Envelope Antigen (HBeAg) Positive Participants With Hepatitis B Virus Deoxyribonucleic Acid (HBV-DNA) Less Than (<) 1,00,000 Copies Per Milliliter (Copies/mL)
大体时间：Week 72
|
HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease.
HBeAg positive participants were defined as those who had HBV DNA greater than (>) 1,00,000 copies/mL at baseline.
This outcome measured the number of participants with HBV-DNA levels < 1,00,000 copies/mL at Week 72, who were defined as HBeAg positive at baseline.
|
Week 72
|
|
Number of HBeAg Negative Participants With HBV-DNA < 10,000 Copies/mL
大体时间：Week 72
|
HBeAg is a soluble antigen of hepatitis B virus present in the blood during acute infection, and disappear afterward but sometimes persisting in chronic disease.
HBeAg negative participants were defined as those who had HBV DNA >10,000 copies/mL at baseline.
This outcome measured the number of participants with HBV DNA <10,000 copies/mL at Week 72, who were defined as HBeAg negative at baseline.
|
Week 72
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With HBV-DNA < 400 Copies/mL
大体时间：Week 72
|
Week 72
|
|
|
Percentage of Hepatitis B Surface Antigen (HBsAg) Negative Participants
大体时间：Week 48 and Week 72
|
HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HBsAg participants.
Percentage of HBsAg negative participants were reported.
|
Week 48 and Week 72
|
|
Percentage of Anti-HBs Positive Participants
大体时间：Week 48 and Week 72
|
HBsAg seroconversion was defined as the absence of HBsAg (HBsAg negative) and the presence of anti-HBs (anti-HBs positive) for HbsAg participants.
Percentage of Anti-HBs positive participants were reported.
|
Week 48 and Week 72
|
|
Mean Alanine Aminotransferase (ALT) Concentrations
大体时间：Week 48 and Week 72
|
Week 48 and Week 72
|
|
|
Percentage of HBeAg Negative Participants
大体时间：Week 48 and Week 72
|
HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg positive participants.
Percentage of HBeAg negative participants were reported.
|
Week 48 and Week 72
|
|
Percentage of Anti-HBe Positive Participants
大体时间：Week 48 and Week 72
|
HBeAg seroconversion was defined as the absence of HBeAg (HBeAg negative) and the presence of anti-HBe (anti-HBe positive) for HBeAg participants.
Percentage of Anti-HBe positive participants were reported.
|
Week 48 and Week 72
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年3月1日
初级完成 (实际的)
2010年5月1日
研究完成 (实际的)
2010年5月1日
研究注册日期
首次提交
2007年2月15日
首先提交符合 QC 标准的
2007年2月15日
首次发布 (估计)
2007年2月16日
研究记录更新
最后更新发布 (估计)
2016年10月24日
上次提交的符合 QC 标准的更新
2016年8月31日
最后验证
2016年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.