The Individualized Management With Pegasys and Ribavirin Offering Viral Eradication (IMPROVE) Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 236
- 主要终点
- Percentage of Participants With Sustained Virological Response (SVR) (Groups A and B)
研究概览
简要总结
This study will compare the efficacy and safety of treatment with pegylated-interferon alfa-2a plus ribavirin in participants with non-genotype 2/3 CHC who, after 12 weeks of study treatment, have undetectable hepatitis C virus (HCV)-ribonucleic acid (RNA) or a greater than or equal to (>=) 2 log10 drop in HCV-RNA. Participants will be randomized to receive pegylated-interferon alfa-2a 180 micrograms subcutaneously weekly plus ribavirin (1000-1400 milligram [mg]) orally daily for the specified duration, followed by 24 weeks of treatment-free follow-up. Participants with detectable HCV-RNA and less than (<) 2 log10 drop in HCV-RNA at week 12 will discontinue therapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •evidence of CHC;
- •evidence of hepatitis C non-genotype 2 or 3;
- •compensated liver disease.
排除标准
- •infection with HCV genotype 2 or 3;
- •history of having received systemic antiviral therapy with activity against CHC <=3 months prior to start of study;
- •hepatitis A, hepatitis B or human immunodeficiency virus (HIV) infection;
- •history or evidence of a medical condition associated with chronic liver disease other than CHC.
研究组 & 干预措施
Pegylated-interferon Alfa-2a + Ribavirin (Group A)
Participants with HCV RNA levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, will receive pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
干预措施: Pegylated-interferon Alfa-2a (Drug)
Pegylated-interferon Alfa-2a + Ribavirin (Group A)
Participants with HCV RNA levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, will receive pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
干预措施: Ribavirin (Drug)
Pegylated-interferon Alfa-2a + Ribavirin (Group B)
Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
干预措施: Pegylated-interferon Alfa-2a (Drug)
Pegylated-interferon Alfa-2a + Ribavirin (Group B)
Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
干预措施: Ribavirin (Drug)
Pegylated-interferon Alfa-2a + Ribavirin (Group C)
Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
干预措施: Pegylated-interferon Alfa-2a (Drug)
Pegylated-interferon Alfa-2a + Ribavirin (Group C)
Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
干预措施: Ribavirin (Drug)
Pegylated-interferon Alfa-2a + Ribavirin (Group D)
Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
干预措施: Pegylated-interferon Alfa-2a (Drug)
Pegylated-interferon Alfa-2a + Ribavirin (Group D)
Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
干预措施: Ribavirin (Drug)
Pegylated-interferon Alfa-2a + Ribavirin (Group E)
Participants with HCV-RNA levels <15 IU/mL at Week 4, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
干预措施: Pegylated-interferon Alfa-2a (Drug)
Pegylated-interferon Alfa-2a + Ribavirin (Group E)
Participants with HCV-RNA levels <15 IU/mL at Week 4, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
干预措施: Ribavirin (Drug)
Pegylated-interferon Alfa-2a + Ribavirin (Group F)
Participants with HCV-RNA levels <15 IU/mL at Week 4, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
干预措施: Pegylated-interferon Alfa-2a (Drug)
Pegylated-interferon Alfa-2a + Ribavirin (Group F)
Participants with HCV-RNA levels <15 IU/mL at Week 4, will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
干预措施: Ribavirin (Drug)
Pegylated-interferon Alfa-2a + Ribavirin (Group NR)
Participants who do not have any change in HCV-RNA levels at Weeks 4, 8, and 12 will not be randomized (NR) to any of the other groups. Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
干预措施: Pegylated-interferon Alfa-2a (Drug)
Pegylated-interferon Alfa-2a + Ribavirin (Group NR)
Participants who do not have any change in HCV-RNA levels at Weeks 4, 8, and 12 will not be randomized (NR) to any of the other groups. Participants will receive pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virological Response (SVR) (Groups A and B)
时间窗: At 24-week untreated follow-up visit (up to 72 weeks for Group A, up to 96 weeks for Group B)
SVR was defined as success if the participant had HCV RNA levels \<15 IU/mL as measured by COBAS AmpliPrep/COBAS TaqMan® HCV test at the 24-week untreated follow-up visit (HCV-RNA levels obtained at least 18 weeks after last dose of either pegylated-Interferon alfa-2a or ribavirin were considered if the 24-week untreated follow-up visit data were missing). Percentage of participants with SVR for Groups A and B was reported in this analysis.
次要结局
- Percentage of Participants With SVR (Groups C, D, E, and F)(At 24-week untreated follow-up visit (up to 60, 72, 48, and 72 weeks for Groups C, D, E, and F, respectively))
- Percentage of Participants With Virological Responses (Groups A, B, C, D, E, and F)(Week 12 (Groups C, D, E, and F), and end of treatment (Weeks 48, 72, 36, 48, 24, and 48 for Groups A, B, C, D, E, and F, respectively))