A Randomized, Multicenter, Open Label Study Evaluating the Efficacy and Safety of Tailored Regimens With Peginterferon Alfa-2a Plus Ribavirin According Viral Kinetics for Genotype 1 Chronic Hepatitis C Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 542
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
The purposes of this study are:
- To test if 36 weeks of standard dose of ribavirin with PEGASYS® is non-inferior to standard dose of 48 weeks of ribavirin with PEGASYS® in SVR for patients with RVR and HVL
- To test if the 72 weeks of treatment with PEGASYS® plus standard dose ribavirin is superior to 48 weeks of the same treatment for patients with HCV RNA seropositivity at week 12
详细描述
The aims of the present study are:
- To evaluate the efficacy and safety of 36-week versus 48-week regimen of PEGASYS® (peginterferon alfa-2a, PegIFN) plus standard-dose of ribavirin (RBV) in hepatitis C virus (HCV) genotype 1 infected, treatment-naïve CHC patients who have high viral loads (HVL, defined as baseline HCV RNA ≧ 400,000 IU/mL) and achieve a rapid virologic response (RVR) (defined as seronegativity of HCV RNA at week 4 of treatment)
- To evaluate the efficacy and safety of 48-week versus 72-week regimen of PegIFN plus standard-dose of RBV in HCV virus genotype 1 infected, treatment-naïve CHC patients with PCR-seropositive of HCV RNA at week 12
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients *18 years of age
- •Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
- •Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
- •Detectable serum HCV-RNA and HCV viral genotype 1
- •Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis (Exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.)
- •Compensated liver disease (Child-Pugh Grade A clinical classification)
- •Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
- •All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end
排除标准
- •Women with ongoing pregnancy or breast feeding
- •Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) *6 months prior to the first dose of study drug
- •Any investigational drug *6 weeks prior to the first dose of study drug
- •Co-infection with active hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV)
- •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)
- •Signs or symptoms of hepatocellular carcinoma
- •History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
- •Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening
研究组 & 干预措施
F: Peg-interferon alpha-2a & Ribavirin
Arm F: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 72 weeks with a follow-up period of 24 weeks.
(Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F a ratio of 1:1)
干预措施: F: Peg-interferon alpha-2a & Ribavirin (Drug)
E: Peg-interferon alpha-2a & Ribavirin
Arm E: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.
(Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F a ratio of 1:1)
干预措施: E: Peg-interferon alpha-2a & Ribavirin (Drug)
D: Peg-interferon alpha-2a & Ribavirin
Arm D: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.
(Patients who do not achieve a RVR but have HCV RNA PCR-seronegative at week 12 of treatment)
干预措施: D: Peg-interferon alpha-2a & Ribavirin (Drug)
C: Peg-interferon alpha-2a & Ribavirin
Arm C: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.
(Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1)
干预措施: C: Peg-interferon alpha-2a & Ribavirin (Drug)
B: Peg-interferon alpha-2a & Ribavirin
Arm B: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 36 weeks with a follow-up period of 24 weeks.
(Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1)
干预措施: B: Peg-interferon alpha-2a & Ribavirin (Drug)
A: Peg-interferon alpha-2a & Ribavirin
Arm A: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 24 weeks with a follow-up period of 24 weeks.
干预措施: A: Peg-interferon alpha-2a & Ribavirin (Drug)
结局指标
主要结局
Efficacy
时间窗: 24-week off-treatment period
Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4 Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period
次要结局
- Safety(24-week off-treatment period)
研究者
Chia-Yen Dai
Professor, School of Medicine, Hepatology Division
Kaohsiung Medical University Chung-Ho Memorial Hospital