Randomized, Multicenter Study to Compare the Efficacy of Pegylated Interferon Alfa (PEG-IFN) in Combination With Two Different Doses of Ribavirin in Patients With Chronic Hepatitis C and Subtype 2/3
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 395
- 主要终点
- Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment
研究概览
简要总结
This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment is 16 or 24 weeks with a 24-week follow-up.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, 18-65 years of age
- •Chronic hepatitis C, genotype 2 or 3
- •Positive HCV RNA level in serum at screening (COBAS AMPLICOR MONITOR HCV test)
- •Abdominal sonography within 3 months prior to study start
排除标准
- •Previous interferon and/or pegylated interferon and ribavirin therapy
- •Liver cirrhosis, class B or C (Child-Pugh)
- •Systemic anti-neoplastic or immunomodulatory treatment <=6 months before study drug
- •History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis C
- •Decompensated liver disease
- •Positive for HIV
研究组 & 干预措施
Peginterferon/Ribavirin 800 mg (24 Weeks)
Participants received peginterferon alfa-2a (PEG-IFNα-2a) 180 mcg once weekly + Ribavirin 800 mg daily for 24 weeks (W).
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
Peginterferon/Ribavirin 800 mg (24 Weeks)
Participants received peginterferon alfa-2a (PEG-IFNα-2a) 180 mcg once weekly + Ribavirin 800 mg daily for 24 weeks (W).
干预措施: ribavirin (Drug)
Peginterferon/Ribavirin 400 mg (24 Weeks)
Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 24 W.
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
Peginterferon/Ribavirin 400 mg (24 Weeks)
Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 24 W.
干预措施: ribavirin (Drug)
Peginterferon/Ribavirin 800 mg (16 Weeks)
Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 800 mg daily for 16 W.
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
Peginterferon/Ribavirin 800 mg (16 Weeks)
Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 800 mg daily for 16 W.
干预措施: ribavirin (Drug)
Peginterferon/Ribavirin 400 mg (16 Weeks)
Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 16 W.
干预措施: peginterferon alfa-2a [Pegasys] (Drug)
Peginterferon/Ribavirin 400 mg (16 Weeks)
Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 16 W.
干预措施: ribavirin (Drug)
结局指标
主要结局
Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment
时间窗: Up to Week 48 (24 weeks post completion of the treatment)
Sustained virological response was defined as the percentage of participants in each group with undetectable Hepatitis C virus-Ribonucleic acid (HCV-RNA) measurement at 24 weeks post completion of the treatment.
Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48
时间窗: At Week 24 and Week 48
Serum Hepatitis C Virus-RNA (HCV-RNA) was done by Polymerase chain reaction (PCR). Samples for a qualitative PCR (AMPLICOR® HCV Test v2.0) were obtained at Week 24 and Week 48. 'G2' and 'G3' indicates Genotype 2 and Genotype 3 respectively.
次要结局
- Percentage of Participants With Virological Response at the End of the Treatment(At Week 16 and Week 24)
- Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment(At Week 16 and Week 24)
- Number of Participants With Any Adverse Events and Any Serious Adverse Events(Up to Week 48)
- Median Hemoglobin Levels at End of Treatment(At Week 16 and Week 24)
- Mean FSS Scores at Baseline and Weeks 16, 24 and 48(At Baseline (Week 0) and Weeks 16, 24 and 48)
- Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48(At Baseline (Week 0) and Weeks 16, 24 and 48)
- Time to Viral Response(Up to Week 48)
- Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48(At Baseline (Week 0) and Weeks 16, 24 and 48)
- Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48(At Baseline (Week 0) and Weeks 4, 8, 12, 24 and 48)