A Phase IV, Randomised, Multicentre, Efficacy and Safety Study Examining the Effect of Induction Dosing With the Combination of Peginterferon Alfa-2a and Ribavirin in Patients With Chronic Hepatitis C Infected With Hepatitis C Genotype 1
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 896
- 主要终点
- Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period
研究概览
简要总结
This study will evaluate the addition of a higher-dose induction treatment period with peginterferon (PEG-IFN) alfa-2a (Pegasys) and ribavirin prior to standard-dose treatment with PEG-IFN alfa-2a and ribavirin, compared to standard-dose treatment, in treatment-naive participants with CHC, genotype 1 infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic CHC, genotype 1
- •Chronic liver disease consistent with CHC on a biopsy sample obtained within the previous 36 months as judged by a local pathologist (all countries except Australia)
- •Infection with Hepatitis C virus (Australian sites only had to meet Section 100 criteria for treatment with PEG-IFN alfa-2a plus ribavirin)
- •Compensated liver disease
- •Naive to interferon-based therapy for CHC infection
排除标准
- •Systemic antiviral, antineoplastic, or immunomodulatory treatment within 6 months of study drug
- •Coinfection with active hepatitis A or B virus, or with human immunodeficiency virus (HIV)
- •Chronic liver disease other than CHC infection
研究组 & 干预措施
PEG-IFN alfa-2a+Ribavirin - Induction Treatment
Participants will receive 12 weeks of induction therapy with PEG-IFN alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses. Thereafter, the dose of PEG-IFN alfa-2a will be reduced to 180 mcg SC once weekly and the ribavirin dose maintained for the remaining 36 weeks of treatment.
干预措施: PEG-IFN alfa-2a (Drug)
PEG-IFN alfa-2a+Ribavirin - Induction Treatment
Participants will receive 12 weeks of induction therapy with PEG-IFN alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses. Thereafter, the dose of PEG-IFN alfa-2a will be reduced to 180 mcg SC once weekly and the ribavirin dose maintained for the remaining 36 weeks of treatment.
干预措施: Ribavirin (Drug)
PEG-IFN alfa-2a+Ribavirin - Standard Treatment
Participants will receive 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses.
干预措施: PEG-IFN alfa-2a (Drug)
PEG-IFN alfa-2a+Ribavirin - Standard Treatment
Participants will receive 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virological Response According to Scheduled Treatment Period
时间窗: Week 72
Sustained virological response was calculated as the percentage of participants with undetectable (less than \[\<\] 15 international units per milliliter \[IU/mL\]) hepatitis C virus (HCV) ribonucleic acid (RNA) as measured by the Roche TaqMan HCV Test 24 weeks after completion of the scheduled 48-week treatment period.
次要结局
- Percentage of Participants With Virological Responses Over Time(Weeks 4, 8, 12, and 24)
- Percentage of Participants With Relapse of End-of-treatment Virological Response(Actual end of treatment (Week 48) up to last follow up (maximum up to Week 72))
- Percentage of Participants With Predictive Values of Virological Response for Sustained Virological Response(Weeks 4, 12, and 72)
- Percentage of Participants With End-of-Treatment Virological Response According to Scheduled Treatment Period(Weeks 48)
- Change From Baseline in Log10 HCV RNA Values(Baseline, Weeks 4, 8, 12, 24, and at end of treatment (EoT) (maximum up to Week 48))