An Open-label, Multicenter, Efficacy and Safety Study of Pegasys® Plus Ribavirin in Patients With Chronic HCV Infection Who Are Unable to Tolerate or Who Do Not Respond to 12 Weeks of Therapy With PEGIntron ® Plus Ribavirin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 57
- 主要终点
- Number of Pegasys and Ribavirin Therapy Completers
研究概览
简要总结
This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the target sample size is >100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •adult patients at least 18 years of age
- •CHC infection, genotype 1
- •unable to tolerate or not responsive to PEG-Intron + ribavirin therapy after 12 weeks of treatment
- •use of 2 forms of contraception during the study in both men and women
排除标准
- •women who are pregnant or breast-feeding
- •medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures)
- •patients with decompensated cirrhosis
- •patients receiving any systemic antiviral therapy or investigational drug, other than PEG-Intron + ribavirin, 24 weeks prior to the first dose of study drug
研究组 & 干预措施
Non-Responders
Participants will receive Pegasys 180 micro grams (µg or mcg) subcutaneously (SC) once a week and ribavirin 1000 or 1200 milligrams per day [(mg/day), < or >=75 kilogram (Kg) body weight, respectively], orally in divided doses for 60 weeks.
干预措施: Ribavirin (Drug)
Non-Responders
Participants will receive Pegasys 180 micro grams (µg or mcg) subcutaneously (SC) once a week and ribavirin 1000 or 1200 milligrams per day [(mg/day), < or >=75 kilogram (Kg) body weight, respectively], orally in divided doses for 60 weeks.
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
Non-Tolerators
Participants will receive Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
干预措施: Ribavirin (Drug)
Non-Tolerators
Participants will receive Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
结局指标
主要结局
Number of Pegasys and Ribavirin Therapy Completers
时间窗: 36 weeks for Non-Tolerators and 60 weeks for Non-Responders
Therapy completers were defined as all participants who had demonstrable viremia after 12 weeks of Pegasys plus ribavirin therapy (who were to be discontinued for lack of efficacy), non-tolerators who completed 36 weeks of Pegasys plus ribavirin therapy, and non-responders who completed 60 weeks of Pegasys plus ribavirin therapy. Study completers included all participants who completed the planned treatment period (36 weeks for non-tolerators and 60 weeks for non-responders) and the 24-week treatment-free follow-up period and participants in either group who were prematurely discontinued per protocol due to insufficient therapeutic response at Week 12.
次要结局
- Number of Participants With >=2-log10 Decrease or Undetectable (<60 International Units Per Milliliter) Hepatitis C Virus-ribonucleic Acid Over Time(Weeks 4, 12, 24, 36, 48, 60, and 84)
- Number of Participants With Normal Serum Alanine Transaminase Levels Over Time(Baseline (Week 0), Weeks 4, 12, 24, 36, 48, 60, and 84)
- Mean Score of Beck Depression Inventory Over Time(Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84)
- Mean Score of Fatigue Severity Over Time(Baseline (Week 0); Weeks 4, 12, 24, 36, 48, 60, and 84)
- Number of Participants With Serious Adverse Events and Adverse Events(Up to Week 84)
- Number of Participants With Individual Flu-like Symptom(Baseline (Week 0); Weeks 12, 36, 60 and 84)
- Number of Participants With Marked Laboratory Abnormalities(Up to Week 84)
- Number of Participants With Abnormal Vital Signs(From screening (Day -21 to Day -1) to Week 84)
- Mean Score for Overall Local Injection Site Reaction(Baseline (Week 0), Week 4, 12, 24, 36, 48 and 60)