A Pilot Study to Treat Patients With Chronic HCV Genotype 1 and ESRD Receiving Hemodialysis and Naïve to Prior HCV Therapy With Peginterferon Alfa-2b, the Maximally Tolerated Ribavirin Dose and Boceprevir
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of patients who achieve eRVR at treatment week 28
研究概览
简要总结
- A maximally tolerated dose of ribavirin can be defined in each patient with ESRD undergoing hemodialysis.
- Patients with Chronic Hepatitis C Virus (HCV)and End-Stage Renal Disease (ESRD)undergoing hemodialysis will be able to tolerate and remain on treatment with peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir.
- A significant percentage of patients with chronic HCV and ESRD undergoing hemodialysis can achieve rapid virologic response (RVR), extended virologic response (eRVR) and sustained virologic response (SVR) when treated with peginterferon alfa-2b, the maximally tolerated dose of ribavirin and boceprevir.
详细描述
Patients with ESRD will be treated with a dose escalation of ribavirin starting from 200 mg everyday (QD) to a maximal tolerated dose. Peginterferon will then be added. Ribavirin will be dose adjusted as needed. Boceprevir will then be added. Ribavirin will be dose adjusted as needed. Patients will be monitored for eRVR and SVR. The study end-point is eRVR.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic HCV defined by:
- •A history of a positive anti-HCV or HCV RNA for > 6 months or
- •A liver biopsy demonstrating at least portal fibrosis
- •HCV genotype 1
- •No prior treatment with any interferon or peginterferon preparation
- •ESRD undergoing hemodialysis for at least 6 months
- •Willingness not to conceive a child during treatment and for 6 months following discontinuation of treatment.
排除标准
- •Histologic evidence of cirrhosis
- •Any co-existent liver disease
- •A platelet count < 90,000
- •A total white blood cell (WBC) < 2.5
- •An absolute neutrophil count < 1.5
- •Hemoglobin < 11 gm/dl on Epoetin-alpha
- •Positive test for anti-HIV
- •Pregnancy of the patient or their intimate partner
- •Women who are breast feeding
- •Significant cardiovascular disease
- •History of suicide intent, severe depression requiring hospitalization or significant psychiatric disease
- •Malignancy within 5 years of enrollment except for squamous or basal cell skin cancer
- •Co-existent immune disorder such as lupus, rheumatoid as arthritis, colitis, Crohns disease, sarcoidosis, etc.
- •Any patient in the opinion of the investigator who would not be a satisfactory study candidate
研究组 & 干预措施
Ribavirin, peginterferon, boceprevir
The efficacy and safety of HCV treatment in patients with ESRD will be assessed with a maximal tolerated dose of ribavirin, peginterferon and boceprevir.
干预措施: Ribavirin (Drug)
Ribavirin, peginterferon, boceprevir
The efficacy and safety of HCV treatment in patients with ESRD will be assessed with a maximal tolerated dose of ribavirin, peginterferon and boceprevir.
干预措施: Peginterferon (Drug)
Ribavirin, peginterferon, boceprevir
The efficacy and safety of HCV treatment in patients with ESRD will be assessed with a maximal tolerated dose of ribavirin, peginterferon and boceprevir.
干预措施: Boceprevir (Drug)
结局指标
主要结局
Percentage of patients who achieve eRVR at treatment week 28
时间窗: 28 weeks
The primary end-point for evaluation will be the percentage of patients who achieve eRVR at treatment week 28.
次要结局
- Tolerability of treatment(48 weeks)