Comparison of PEG-Intron 1.5µg/kg/wk Plus REBETOL vs PEG-Intron 1µg/kg/wk Plus REBETOL vs PEGASYS 180µg/wk Plus COPEGUS in Previously Untreated Adult Subjects With Chronic Hepatitis C Infected With Genotype 1
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 4,469
- 主要终点
- Sustained Virologic Response (SVR) Rate
研究概览
简要总结
The objective is to compare the safety and efficacy of the following three treatment regimens in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1) PegIntron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2) PegIntron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3) PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.
详细描述
PegIntron Dose will be administered once weekly subcutaneously on the same day of the week:
Screening 2 Weight 40-50 kg Volume to Inject (mL) 0.22; Screening 2 Weight 51-60 kg Volume to Inject (mL) 0.28; Screening 2 Weight 61-75 kg Volume to Inject (mL) 0.33; Screening 2 Weight 76-85 kg Volume to Inject (mL) 0.41; Screening 2 Weight 86-104 kg Volume to Inject (mL) 0.48; Screening 2 Weight 105-125 kg Volume to Inject (mL) 0.58 from two vials
REBETOL Dosage (for Use With PegIntron):
Screening 2 Weight 40-65 kg Daily Dose 800 mg; Screening 2 Weight >65-85 kg Daily Dose 1000 mg; Screening 2 Weight >85-105 kg Daily Dose 1200 mg; Screening 2 Weight >105-125 kg Daily Dose 1400 mg
The PEGASYS dose of 1 mL (180 µg) will be administered once weekly subcutaneously on the same day of the week
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
PegIntron 1.5 ug/kg/wk plus REBETOL
PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
干预措施: PegIntron (peginterferon alfa-2b; SCH 54031) (Biological)
PegIntron 1.5 ug/kg/wk plus REBETOL
PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
干预措施: REBETOL (ribavirin; SCH 18908) (Drug)
PegIntron 1.0 ug/kg/wk plus REBETOL
PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
干预措施: PegIntron (peginterferon alfa-2b; SCH 54031) (Biological)
PegIntron 1.0 ug/kg/wk plus REBETOL
PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
干预措施: REBETOL (ribavirin; SCH 18908) (Drug)
PEGASYS 180 ug/wk Plus COPEGUS
PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
干预措施: PEGASYS (peginterferon alfa-2a) (Biological)
PEGASYS 180 ug/wk Plus COPEGUS
PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
干预措施: COPEGUS (ribavirin) (Drug)
结局指标
主要结局
Sustained Virologic Response (SVR) Rate
时间窗: Assessed at the end of a 24-week post-treatment follow-up
SVR rate is the percentage of participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of the 24-week post-treatment follow-up.
次要结局
- Virologic Response Rate at Treatment Week 12(Assessed at Treatment Week 12)
- Mean Change From Baseline in the Log Viral Load at Treatment Week 2(Assessed at Baseline and Treatment Week 2)
- Mean Change From Baseline in the Log Viral Load at Treatment Week 4(Assessed at Baseline and Treatment Week 4)