Randomized, Multicenter, Double-blind, Phase IV Pilot Study Evaluating the Effect of PEGASYS Doses of 180 ug or 270 ug in Combination With Copegus Doses of 1200 mg or 1600 mg on Viral Kinetics, Virological Response, Pharmacokinetics, and Safety in Interferon-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Body Weight Greater Than 85 kg
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 188
- 主要终点
- HCV RNA Profile During The First 24 Weeks
研究概览
简要总结
The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
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
- 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;
- •body weight >85kg (187lbs);
- •CHC (genotype 1);
- •liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;
- •use of 2 forms of contraception during study and 6 months after the study in both men and women.
排除标准
- •women who are pregnant or breastfeeding;
- •male partners of women who are pregnant;
- •conditions associated with decompensated liver disease;
- •other forms of liver disease, including liver cancer;
- •human immunodeficiency virus infection;
- •previous treatment with an interferon, ribavirin, viramidine, levovirin or amantadine.
研究组 & 干预措施
PEG-IFN Alfa-2a 180 μg +Ribavirin 1200 mg
Participants received 180 μg of PEG-IFN [peginterferon] alfa-2a in 1 mL solution administered [subcutaneously] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks
干预措施: ribavirin [Copegus] (Drug)
PEG-IFN Alfa-2a 180 μg +Ribavirin 1200 mg
Participants received 180 μg of PEG-IFN [peginterferon] alfa-2a in 1 mL solution administered [subcutaneously] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks
干预措施: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys] (Drug)
PEG-IFN Alfa-2a 180 μg + Ribavirin 1600 mg
Participants received 180 μg of PEG-IFN [peginterferon] alfa-2a in 1 mL solution administered [subcutaneously] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks
干预措施: ribavirin [Copegus] (Drug)
PEG-IFN Alfa-2a 180 μg + Ribavirin 1600 mg
Participants received 180 μg of PEG-IFN [peginterferon] alfa-2a in 1 mL solution administered [subcutaneously] sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks
干预措施: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys] (Drug)
PEG-IFN Alfa-2a 270 μg + Ribavirin 1200 mg
Participants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
干预措施: ribavirin [Copegus] (Drug)
PEG-IFN Alfa-2a 270 μg + Ribavirin 1200 mg
Participants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
干预措施: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys] (Drug)
PEG-IFN Alfa-2a 270 μg + Ribavirin 1600 mg
Participants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
干预措施: ribavirin [Copegus] (Drug)
PEG-IFN Alfa-2a 270 μg + Ribavirin 1600 mg
Participants received 270 μg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
干预措施: peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys] (Drug)
结局指标
主要结局
HCV RNA Profile During The First 24 Weeks
时间窗: Baseline (Day 1), At 72 hour (h), Week (W)-1, 2, 4, 12, 24
Viral loads (quantitative HCV RNA) collected during the initial 24 weeks were first logarithmically (based 10) transformed. Results falling below the assay sensitivity level were set to the assay sensitivity level before the analyses. Thus, a qualitative HCV RNA negative result was set to 50 IU/mL (or 100 copies/mL). A qualitative HCV RNA positive result along with an unquantifiable HCV RNA result from the quantitative assay corresponded to a numeric HCV RNA result of 600 IU/mL (or 1000 copies/mL).
Percentage of Participants With Virological Response Over Time to Week 24
时间窗: 72 hours post-dose, Weeks 1, 2, 4, 12, and 24
Virological response over time to Week 24 is defined as the percentage of participants with undetectable HCV RNA as measured by the Roche Amplicor HCV Test, V. 2.0 (detection limit = 50 IU/mL) at 72 hours and at weeks 1, 2, 12, and 24.
Percentage of Participants With Predicted Sustained Virological Response
时间窗: Week 4 and 12
The predicted sustained virological response (SVR) for each treatment group, is determined using a model based on the log10-transformed HCV viral load in copies/mL at Week 4 and the virological response status at Week 12. Each participant was classified as a predicted SVR if p was ≥ 0.5 or as a non-SVR if p was \<0.5. The percentage was calculated from the number of participant (N) analyzed under "Distribution of the predicted probability of an SVR."
次要结局
- Percentage of Participants With Sustained Virological Response(Week 72)
- Percentage of Participants With Virological Response at the End of the Treatment Period(Week 48)
- Percentage of Participants With Virological Response At 12 Weeks After The End of The Treatment Period(Week 60)
- Percentage of Participants With Adverse Events and Serious Adverse Events(Up to Week 72)
- Percentage of Participants With Marked Laboratory Abnormalities(Up to Week 60)
- Percentage of Participants With Abnormal Vital Signs(Up to Week 72)
- Total BDI-II (Beck Depression Inventory) Scores(From Baseline (Day 1) to Week 72)