Multicenter Open-label Observation Program in Patients With Chronic Hepatitis C and With Chronic Renal Failure (CRF) Receiving Peginterferon Alpha-2a (40 kDa) Pegasys
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion
研究概览
简要总结
This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis C and end-stage renal disease, including patients on hemodialysis. Patients will receive PEGASYS at a dose of 180 micrograms weekly; those with a calculated glomerular filtration rate of <15mL/min will receive a reduced dose of 135 micrograms weekly. Following 48 weeks of treatment there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-60 years of age;
- •chronic hepatitis C;
- •chronic renal failure, including patients on hemodialysis therapy;
- •detectable HCV RNA levels (>500IU/mL).
排除标准
- •concurrent active hepatitis A or B;
- •history or evidence of a medical condition associated with chronic liver disease other than HCV;
- •history or other evidence of decompensated liver disease;
- •therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment <=6 months prior to study;
- •acute renal failure.
研究组 & 干预措施
Peginterferon Alpha-2a
Eligible participants will be administered peginterferon alpha-2a [Pegasys] (40 kilo Dalton), 180 micrograms as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated glomerular filtration rate of <15 milliliter /minute will be administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
结局指标
主要结局
Percentage of Participants Achieving Sustained Virologic Response at 24 Weeks Following Treatment Completion
时间窗: At Week 72
Sustained virologic response is defined as undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels (\<50 international units \[IU\]/mL) at 24 weeks following the completion of 48 weeks treatment period (Week 72).
Percentage of Participants With Undetectable Hepatitis C Virus Ribonucleic Acid Level at Week 24 and Week 48
时间窗: At Week 24 and Week 48
HCV RNA level less than 50 IU/mL was considered to be undetectable.
Percentage of Participants With At Least a 2log10 Drop in Hepatitis C Virus Ribonucleic Acid at Week 24 as Compared to Baseline
时间窗: From Baseline (Days -30 to -1) and Week 24
The table below shows the percentage of participants with at least 2log10 drop in HCV RNA level at Week 24 as compared to Baseline (Screening visit \[Days -30 to -1\]).
次要结局
- Number of Participants With Any Marked Abnormality in Laboratory Parameters Over a Period of 72 Weeks(Up to Week 72)
- Mean Change From Baseline in Heart Rate up to Week 72(From Baseline (Days -30 to -1) to Week 72)
- Number of Participants Who Experienced Any Adverse Events or Serious Adverse Events(Up to Week 72)
- Number of Participants Who Prematurely Withdrew From the Treatment Over a Period of 48 Weeks(Up to Week 48)
- Mean Change From Baseline in Blood Pressure up to Week 72(From Baseline (Days -30 to -1) to Week 72)