A Multicenter, Prospective, Observational, Non-Interventional Cohort Study Evaluating Sustained Response in Subjects With HBeAg Positive Chronic Hepatitis B Receiving Therapy With Pegasys (Peginterferon Alfa-2a) in Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 主要终点
- Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL at 6 Months After End of Treatment
研究概览
简要总结
This prospective, multicenter, observational study will evaluate the sustained response in patients with HBeAg positive chronic hepatitis B who are treated with Pegasys according to standard of care and in line with the current local labeling in routine clinical practice in Vietnam. Eligible patients will be followed for the duration of their treatment and for up to 2 years thereafter.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients, >/= 18 years of age
- •HBeAg-positive serologically proven chronic hepatitis B with or without cirrhosis
- •Elevated serum ALT > ULN (upper limit of normal) but </= 10 x ULN
- •Patients with no contra-indications to Pegasys therapy as detailed in the label
- •Written informed consent where local regulations allow or require it
排除标准
- •Patients should not receive concomitant therapy with telbivudine
- •Co-infection with hepatitis A, hepatitis B or HIV
- •Pregnant or breastfeeding women
- •Patients with depression/mental diseases
- •Neutrophil at baseline > 90.000/mm3
- •Abnormal T4 or TSH
结局指标
主要结局
Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL at 6 Months After End of Treatment
时间窗: 6 months
A participant was considered to have achieved suppression of Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) to \<2,000 International Units Per Milliliter (IU/mL) if the HBV DNA measurement is lower than 2,000 IU/mL.
Percentage of Participants Who Become Hepatitis B Envelope Antigen-Negative and Anti-HBe-Positive During Treatment and at 6 and 12 Months After End of Treatment
时间窗: 12 months
HBeAg is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people. HBeAg-negative hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus.
次要结局
- Percentage of Participants With Suppression of Hepatitis B Virus Deoxyribonucleic Acid To <2,000 IU/mL During the Observation Period(Up to 24 months)
- Percentage of Participants With Hepatitis B Envelope Antigen Seroconversion and Hepatitis B Virus Deoxyribonucleic Acid Suppression (<2,000 IU/mL) During the Observation Period(Up to 24 months)
- Percentage of Participants With Loss of Hepatitis B Envelope Antigen During the Observation Period(Up to 24 months)
- Number of Participants With Incidence of Adverse Events(Up to 24 months)
- Percentage of Participants Who Become Hepatitis B Envelope Antigen Negative During the Observation Period(Up to 24 months)
- Incidence of Normalization of Serum Alanine Transaminase(Up to 24 months)