NCT01861444
终止
不适用
National, Multicenter, Observational Study Evaluating Prevalence, Virological and Clinical Characteristics of Chronic Hepatitis Delta in Romania and Assess Efficacy of Peg-interferon Alfa-2a Treatment in Patients With Chronic Hepatitis D (CHD)
概览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 45
- 主要终点
- Response rate: Proportion of patients achieving ALT normalization and HDV RNA negativity 24 weeks after the end of treatment
概览
简要总结
This prospective, multicenter, observational study will assess the prevalence of chronic hepatitis D in patients with chronic hepatitis B in Romania and evaluate the efficacy of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis D. Eligible patients treated with Pegasys according to current medical practice will be followed until 24 weeks after the end of treatment.
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
- 是
入选标准
- •For epidemiological part of the study:
- •Adult patients \>/= 18 years of age
- •Positive HBsAg for at least 6 months
- •For the non-interventional section of the study
- •Adult patients, \>/= 18 years of age
- •Positive HBsAg for at least 6 months
- •Positive anti-delta and positive HDV RNA by PCR
- •Elevated serum ALT \>/= 2x ULN
排除标准
- •Patients with any of the following will not be eligible for treatment with Pegasys:
- •History of neurological disease
- •History of severe psychiatric disease
- •Decompensated diabetes
- •History of immunologically mediated disease
- •History of severe cardiac disease
- •History or other evidence of severe chronic pulmonary disease
- •Inadequate hematologic function
结局指标
主要结局
Response rate: Proportion of patients achieving ALT normalization and HDV RNA negativity 24 weeks after the end of treatment
时间窗: approximately 3.5 years
Proportion of chronic hepatitis B patients in Romania with chronic hepatitis D infection
时间窗: approximately 3.5 years
次要结局
- Virological characteristics (HBeAg/anti-HBe/HBV DNA/anti-HDV Ab/HDV RNA) of patients with chronic hepatitis D(approximately 3.5 years)
- Proportion of chronic hepatitis D patients with liver cirrhosis(approximately 3.5 years)
研究者
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