Randomized, Multicenter, Double-blinded, Phase IV Study Evaluating the Efficacy (as Measured by Sustained Virological Response) and Safety of 360 μg Induction Dosing of Pegasys® in Combination With Higher Copegus® Doses in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Baseline Body Weight Greater Than or Equal to 85 kg
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,175
- 主要终点
- Sustained Virological Response (SVR)-24 (Scheduled Treatment Period)
研究概览
简要总结
This 4-arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus, and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C (CHC) genotype 1 infection of high viral titer, and baseline body weight ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) PEGASYS 180 µg subcutaneously (sc) weekly plus Copegus 1200 mg orally (po) daily; b) PEGASYS 180 µg sc weekly plus Copegus 1400-1600 mg po daily; c)PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1200 mg po daily; or d) PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1400-1600 mg po daily. Following 48 weeks 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 500+ individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Adult patients, ≥18 years of age
- •CHC infection, genotype 1
- •Hepatitis C virus (HCV) RNA ≥400,000 IU/mL
- •Baseline body weight ≥85 kg
- •Liver biopsy (within 24 months of first dose) with results consistent with CHC
排除标准
- •Previous treatment with interferon, ribavirin, viramidine, levovirin, HCV polymerase or protease inhibitors
- •Other forms of liver disease, including liver cancer
- •Human immunodeficiency virus infection
研究组 & 干预措施
PEG-IFN 180 µg + Ribavirin 1200 mg
干预措施: peginterferon alfa-2a (Drug)
PEG-IFN 180 µg + Ribavirin 1200 mg
干预措施: Ribavirin (Drug)
PEG-IFN 180 µg + Ribavirin 1400/1600 mg
干预措施: peginterferon alfa-2a (Drug)
PEG-IFN 180 µg + Ribavirin 1400/1600 mg
干预措施: Ribavirin (Drug)
PEG-IFN 360/180 µg + Ribavirin 1200 mg
干预措施: Ribavirin (Drug)
PEG-IFN 360/180 µg + Ribavirin 1200 mg
干预措施: peginterferon alfa-2a (Drug)
PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
干预措施: peginterferon alfa-2a (Drug)
PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
干预措施: Ribavirin (Drug)
结局指标
主要结局
Sustained Virological Response (SVR)-24 (Scheduled Treatment Period)
时间窗: Week 72
SVR-24 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the treatment period (a single last HCV RNA PCR \<15 IU/mL measured at or after week 68 (ie, on or after study day 477).
次要结局
- SVR-24 (Actual Treatment Period)(24 weeks after end of treatment)
- SVR-12 (Scheduled Treatment Period)(12 weeks after end of treatment)
- SVR-12 (Actual Treatment Period)(12 weeks after end of treatment)