NCT01705717已完成不适用
Treatment Outcomes in the Management of Patients With Chronic Hepatitis C: A Case Study of Faculty of Medicine Vajira Hospital, University of Bangkok Metropolis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy
研究概览
简要总结
This retrospective, observational study will assess the real world treatment out comes in the management of patients with chronic hepatitis C. No prospective ass essment or procedure with patients during this study will be conducted. Data wil l be collected from patient medical records of the year 2000-2011.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients newly diagnosed with chronic hepatitis C during the year 2000 to 2010
- •Availability of data for at least 6 months following the diagnosis date
排除标准
- •Patients who participated in an investigational clinical trial
- •Co-infection with hepatitis A, hepatitis B, hepatitis D, and/or human immunodeficiency virus (HIV)
- •Patients with known severe medical conditions that are contraindicated to HCV treatment
结局指标
主要结局
Sustained Virological Response (SVR): Percentage of Participants Who Were HCV Seronegative at 6 Months After Completing Therapy
时间窗: 6 months
SVR was defined a negative result upon polymerase chain reaction (PCR) ribonucleic acid (RNA) diagnostic testing after 6 months of treatment.
次要结局
- Percentage of Participants Who Progressed From CHC to Cirrhosis(Diagnosis and End of Study, up to 36 months after diagnosis.)
- Percentage of Participants With HCV Relapse (Biochemical or Virological) After Treatment Completion(End of Study, up to 36 months after diagnosis.)
- Percentage of Participants Who Progressed From CHC to Hepatocellular Carcinoma (HCC)(Diagnosis and End of Study, up to 36 months after diagnosis.)
- Percentage of Participants Who Were HCV Seronegative at the End of Treatment(End of Study, up to 36 months after diagnosis.)
- Percentage of Participants Who Died(Diagnosis and End of Study, up to 36 months after diagnosis)
研究者
研究点 (1)
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