A Randomized, Open-Label, Multicenter, Parallel Group Study Evaluating the Efficacy and Safety of 135 μg and 90 μg of PEGASYS® Given as Monotherapy to Patients With Chronic Hepatitis C and End-Stage Renal Disease Undergoing Hemodialysis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 81
- 主要终点
- Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Treatment
研究概览
简要总结
This study evaluated the safety and efficacy of peginterferon alfa-2a monotherapy in participants with Chronic Hepatitis C (CHC) who have End-Stage Renal Disease (ESRD) and were undergoing hemodialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Serum hepatitis C virus ribonucleic acid (HCV RNA) quantifiable at greater than (>) 600 IU/mL
- •Liver biopsy consistent with chronic hepatitis C infection obtained within 2 years of enrollment
- •Compensated liver disease without cirrhosis
- •Participants with end-stage renal disease undergoing hemodialysis
- •Negative serum pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
- •All fertile participants must have been using effective contraception during treatment with study drug
排除标准
- •Interferon therapy at any previous time
- •Liver cirrhosis
- •Signs and symptoms of hepatocellular carcinoma
- •History or other evidence of decompensated liver disease
- •Any investigational drug less than or equal to 6 weeks prior to the first dose of study drug
- •History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- •Poorly controlled diabetes
- •Thyroid dysfunction not adequately controlled
- •Evidence of severe retinopathy or clinically relevant ophthalmological disorder
- •Severe hyperparathyroidism defined as intact Parathyroid Hormone (PTH) > 800 picogram/milliliter (pg/mL)
- •Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment ≤ 6 months prior to the first dose of study drug
- •Acute renal failure
- •Women with ongoing pregnancy or breast feeding
- •Positive test at screening for anti-HAV IgM Ab (hepatitis A virus immunoglobulin M antibody), hepatitis B surface antigen (HBsAg), anti-HBc (hepatitis B core) IgM Ab, anti-HIV (human immunodeficiency virus) Ab
研究组 & 干预措施
Peginterferon alfa-2a 135 microgram (mcg)
Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
干预措施: Peginterferon alfa-2a (Drug)
Peginterferon alfa-2a 90 mcg
Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
干预措施: Peginterferon alfa-2a (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Treatment
时间窗: 24 weeks after end of treatment (Week 72)
SVR was defined as the percentage of patients with undetectable HCV RNA. SVR rate was calculated as the number of participants with an undetectable HCV RNA divided by the number of participants of the respective participant population. The last single HCV RNA less than (\<) 50 international units per millilitre (IU/mL) measured \>=140 days after treatment end (i.e., \>= 20 weeks after treatment end) was used to determine SVR. Participants without measurements in this time window were considered to be nonresponders.
次要结局
- Percentage of Participants With Virological Response (Non-detectable Hepatitis C Virus-ribonucleic Acid [HCV RNA]) at End of Treatment (EOT)(EOT (Week 48))
- Percentage of Participants With Virological Response (at Least a 2-log 10 Decrease in HCV RNA as Compared With Baseline or Unquantifiable [Less Than {<} 600 International Unit/Milliliter {IU/mL}] or Undetectable HCV RNA [< 50 IU/mL]) at Week 12 and 24(Weeks 12 and 24)