Open-Label, Phase 3b Study To Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Genotype 1 Infected, Stable Liver Transplant Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 74
- 主要终点
- Number of patients achieving sustained virologic response (SVR) 12 planned
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of telaprevir in combination with Peg-IFN-alfa-2a and ribavirin in stable liver transplant patients with chronic hepatitis C virus (HCV) genotype 1.
详细描述
This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First time liver transplant recipient whose primary pre-transplant diagnosis was chronic hepatitis C genotype 1
- •More than 6 months to 10 years post-liver transplant
- •Patient did or did not receive treatment for HCV prior to liver transplantation
- •Patient must agree to have a liver graft biopsy during the screening period unless they had a biopsy within three months of the screening period (for patients between 6 months and one year post transplant) or within six months of the screening period (for patients who are more than one year post transplant)
- •A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of ribavirin
排除标准
- •Patient is currently infected or co-infected with HCV of another genotype than genotype 1
- •Patient received treatment for hepatitis C following liver transplantation
- •Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
- •Patient with human immunodeficiency virus or hepatitis B virus co-infection
- •Patient with active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma or hepatocellular carcinoma)
研究组 & 干预措施
Telaprevir+Peg-IFN-alfa-2a+Ribavirin
Patients will be treated for 12 weeks with telaprevir in combination with Pegylated interferon alfa-2a (Peg-IFN-alfa-2a) and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone.
干预措施: Telaprevir (Drug)
Telaprevir+Peg-IFN-alfa-2a+Ribavirin
Patients will be treated for 12 weeks with telaprevir in combination with Pegylated interferon alfa-2a (Peg-IFN-alfa-2a) and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone.
干预措施: Pegylated interferon alfa-2a (Drug)
Telaprevir+Peg-IFN-alfa-2a+Ribavirin
Patients will be treated for 12 weeks with telaprevir in combination with Pegylated interferon alfa-2a (Peg-IFN-alfa-2a) and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Number of patients achieving sustained virologic response (SVR) 12 planned
时间窗: Week 60
SVR12 planned is defined as having plasma hepatitis C virus (HCV ) ribonucleic acid (RNA) level less than 25 IU/mL 12 weeks after the last planned dose of study medication.
次要结局
- Number of patients having an undetectable HCV RNA level at Week 12 of treatment(Week 12)
- Number of patients having undetectable HCV RNA levels at Week 4 and Week 12 of treatment(Week 4 and Week 12)
- Number of patients having an undetectable HCV RNA level at the actual end of treatment(Week 48)
- Number of patients with on-treatment virologic failure(Week 48)
- Number of patients having an undetectable HCV RNA level at Week 4 of treatment(Week 4)
- Number of patients achieving SVR12 planned(c)(Week 60)
- Number of patients achieving SVR24 planned(Week 72)
- Number of patients achieving SVR24 planned(c)(Week 72)
- Number of patients having an undetectable HCV RNA level at the planned end of treatment(Week 48)
- Number of patients having less than 25 IU/mL at the planned end of treatment(Week 48)
- Number of patients with relapse after undetectable HCV RNA at actual end of treatment(Week 48)
- Number of patients with relapse after undetectable HCV RNA at planned end of treatment(Week 48)
- Number of patients with relapse after previous HCV RNA less than 25 IU/mL at planned end of treatment(Week 48)
- Number of patients with viral breakthrough(Week 48)
- Change from baseline in log HCV RNA values(Up to Week 52)
- Number of patients who have changes in liver graft biopsy histology(Up to Week 72)
- Number of patients with adverse events(Up to Week 72)