Comparison of Two Triple Regimens for Treatment and Retreatment of Chronic Hepatitis C Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Virologic Response
研究概览
简要总结
The purpose of this observational study is to compare two approved treatment regimen(s) containing boceprevir and telaprevir, as part of standard of care for the treatment of hepatitis C.
详细描述
The objective of the study is to compare the effect of adding 2 oral hepatitis C virus (HCV) protease inhibitors, telaprevir versus boceprevir, as part of current standard treatment regimen with (pegylated-interferon-alpha + ribavirin) for HCV Genotype-1 infection. Data will be obtained from medical records of consenting patients.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age - 18-64 years
- •HCV genotype 1
- •HCV RNA >100,000
- •Liver biopsy within 5 years before enrollment
- •Absolute neutrophil count of at least 1200 per cubic millimeter
- •Platelet count of at least 90,000 per cubic millimeter
- •Hemoglobin level of at least 12 g per deciliter
- •Signed informed consent and Health Insurance Portability and Accountability Act (HIPAA) forms
排除标准
- •HCV genotypes other than genotype 1
- •Immunocompromised conditions including HIV, transplant or immunosuppressive drugs
- •Decompensated liver disease or hepatocellular carcinoma
- •Any other types of active cancer
- •Active autoimmune disorders
- •Major psychiatric disorders
- •Active drug or alcohol use
- •Pregnancy or lactation
- •Patients with allergy to any of the drugs used in this study
- •Drugs that may interact with boceprevir or telaprevir as listed in the package insert
结局指标
主要结局
Virologic Response
时间窗: up to 96 weeks post treatment
Sustained Virologic Response (SVR) rates will be compared between the two arms of treatment through measured HCV RNA levels after 24 weeks, 48 weeks and 96 weeks after completion of treatment.
次要结局
- Effect of baseline variables on treatment outcome(24, 48, and 96 weeks post treatment)
- Adverse events(24, 48, and 96 weeks post treatment)