NCT01610115Unknown不适用
Serial HBV DNA Levels During Pregnancy in Patients With Chronic Hepatitis B: a Prospective Observational Follow-up Study
Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
To elucidate the natural course of chronic hepatitis B by serial HBV DNA and alanine aminotransferase (ALT) levels during pregnancy
详细描述
This is a prospective observational follow-up study in a single center.
Number of patients: It is estimated to enroll 100 patients in Taiwan.
Population:
Female patients with pregnancy confirmed, at least 20 years of age diagnosed with chronic hepatitis B. The patients are able to communicate well, provide informed consent and willing to participate in the entire study.
Inclusion criteria:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Documented chronic hepatitis B defined by clinical history compatible with chronic hepatitis B and detectable serum HBsAg
- •Female 20 years of age with confirmed pregnancy
- •Willing and able to comply with all the requirements in the observational follow-up study
- •Willing and able to provide written informed consent to participate in the study
排除标准
- •Concurrent infection with hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV)
- •One or more known primary or secondary causes of liver disease other than hepatitis B (e.g., alcoholism, non-alcoholic steatohepatitis, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease).
- •Any other concurrent medical or psychosocial condition likely to preclude compliance with the schedule of evaluations in the protocol or likely to confound the efficacy or safety observations of the study.
- •Enrolled or planning to enroll in another clinical trial of an investigational agent while participating in this study.
- •Patients with antiviral therapy to chronic hepatitis B
研究者
Yi-Cheng Chen
Yi-Cheng Chen
Chang Gung Memorial Hospital
研究点 (1)
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