NCT01794234终止不适用
Efficacy and Safety of Peginterferon Alfa-2a (40 KD) in Chronic Hepatitis B Patients, Who Have Failed Anti-viral Treatment With Nucleoside (Nucleotide) Analogues - an Observational Study in Real-life Clinical Practice
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 44
- 主要终点
- Efficacy: HBsAg seroclearance/seroconversion rate at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up)
研究概览
简要总结
This observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with nucleoside (nucleotide) analogues. Data will be collected from patients treated according to the current Summary of Product Characteristics and local standard of care and regulations during 48 weeks of treatment and 24 weeks of follow-up.
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
- •Positive HBsAg for more than 6 months before assignment to treatment with Pegasys
- •Detectable HBV DNA (as measured by PCR)
- •HBeAg positive and negative patients
- •Patients previously treated with nucleoside (nucleotide) analogues who have failed antiviral treatment and have been assigned to treatment with Pegasys according to the local therapeutic standard
- •Elevated serum alanine aminotransferase (ALT)
- •Chronic hepatitis B confirmed by liver biopsy or non-invasive assessment (FibroScan), ARFI, FibroTest) or by clinical evaluation
排除标准
- •Contraindications to treatment with Pegasys according to the Summary of Product Characteristics
- •Hepatocellular carcinoma and/or severe hepatic dysfunction or decompensated cirrhosis of the liver
- •Immunosuppression, immunomodulatory or chemotherapy within the last 6 months prior to start of Pegasys treatment
- •Planned other than Pegasys antiviral treatment during Pegasys therapy
- •Chronic liver disease other than chronic hepatitis B
- •Pregnant or breast-feeding women
- •Inadequate hematologic function
- •Autoimmunology disorders
- •Co-infection with chronic hepatitis C or HIV
结局指标
主要结局
Efficacy: HBsAg seroclearance/seroconversion rate at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up)
时间窗: approximately 2.5 years
次要结局
- For HBeAg negative patients: Proportion of patients with HBV DNA </= 2000 IU/ml and ALT normalization(approximately 2.5 years)
- Safety: Incidence of adverse events(approximately 2.5 years)
- HBs levels in correlation with treatment outcome(approximately 2.5 years)
- For HBeAg positive patients: Proportion of patients with HBeAg loss and presence of anti HBe (HBeAg seroconversion) at the end of Week 72 (48 weeks of treatment and 24 weeks of follow-up)(approximately 2.5 years)
研究者
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