Safety, Antiviral Effect and Pharmacokinetics of BI 207127 in Combination With BI 201335 and With or Without Ribavirin for 4, 16, 24, 28 or 40 Weeks in Patients With Chronic HCV Genotype 1 Infection (Randomized Phase Ib/II)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 488
- 试验地点
- 53
- 主要终点
- Part 1: Rapid Virological Response (RVR)
研究概览
简要总结
The substances BI 201335 and BI 207127 are being developed for the treatment of chronic hepatitis C virus infection. BI 201335 and BI 207127 work by preventing the virus from replicating.
The currently available medications pegylated interferon alfa and ribavirin for hepatitis C ca have considerable adverse events in patients and in many cases are not sufficiently effective. This is particularly the case in treatment of patients infected with genotype 1 of HCV.
A combination therapy of these new substances without pegylated interferon alfa may be associated with fewer adverse events that currently available (pegylated interferon-alfa-based) medication and may also provide a treatment option to the large number of patients with contraindications or intolerance to pegylated interferon alfa.
This clinical trial (1241.21) currently consists of 3 distinct studies: Part 1, Part 2 and Part 3.
Part 1 (SOUND-C1) is a 2 armed study as described in experimental arms 1 and 2 below (actual enrollment: 56 patients; randomized and treated: 32) Part 2 (SOUND-C2) is a 5 armed study as described in experimental arms 3 to 7 below (actual enrollment: 465; randomized and treated: 362) Part 3 (SOUND-C3) includes 3 arms as described in experimental arms 8 to 10 below (83 patients randomized and treated)
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
2
4 weeks of high dose TID BI 207127 and QD BI 201335 in combination with RBV, Part 1
干预措施: Ribavirin (Drug)
2
4 weeks of high dose TID BI 207127 and QD BI 201335 in combination with RBV, Part 1
干预措施: BI 201335 (Drug)
2
4 weeks of high dose TID BI 207127 and QD BI 201335 in combination with RBV, Part 1
干预措施: BI 207127 (Drug)
1
4 weeks of low dose three times per day (TID) BI 207127 and once daily (QD) BI 201335 in combination with RBV, Part 1
干预措施: BI 207127 (Drug)
1
4 weeks of low dose three times per day (TID) BI 207127 and once daily (QD) BI 201335 in combination with RBV, Part 1
干预措施: BI 201335 (Drug)
1
4 weeks of low dose three times per day (TID) BI 207127 and once daily (QD) BI 201335 in combination with RBV, Part 1
干预措施: Ribavirin (Drug)
3
16 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
干预措施: BI 207127 (Drug)
3
16 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
干预措施: BI 201335 (Drug)
3
16 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
干预措施: Ribavirin (Drug)
4
28 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
干预措施: BI 207127 (Drug)
4
28 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
干预措施: Ribavirin (Drug)
4
28 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
干预措施: BI 201335 (Drug)
5
40 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
干预措施: BI 201335 (Drug)
5
40 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
干预措施: BI 207127 (Drug)
5
40 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 2
干预措施: Ribavirin (Drug)
6
28 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 2
干预措施: Ribavirin (Drug)
6
28 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 2
干预措施: BI 201335 (Drug)
6
28 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 2
干预措施: BI 207217 (Drug)
7
28 weeks of TID BI 207127 and QD BI 201335 without RBV, Part 2
干预措施: BI 207127 (Drug)
7
28 weeks of TID BI 207127 and QD BI 201335 without RBV, Part 2
干预措施: BI 201335 (Drug)
8
16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3
干预措施: BI 207127 (Drug)
8
16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3
干预措施: Ribavirin (Drug)
8
16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3
干预措施: BI 201335 (Drug)
9
24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3
干预措施: BI 207127 (Drug)
9
24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3
干预措施: BI 201335 (Drug)
9
24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 3
干预措施: Ribavirin (Drug)
10
24 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 3
干预措施: BI 201335 (Drug)
10
24 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 3
干预措施: BI 207127 (Drug)
10
24 weeks of TID BI 207127 and QD BI 201335 in combination with RBV, Part 3
干预措施: Ribavirin (Drug)
11
16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4
干预措施: Ribavirin (Drug)
11
16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4
干预措施: BI 207127 (Drug)
11
16 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4
干预措施: BI 201335 (Drug)
12
24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4
干预措施: Ribavirin (Drug)
12
24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4
干预措施: BI 201335 (Drug)
12
24 weeks of BID BI 207127 and QD BI 201335 in combination with RBV, Part 4
干预措施: BI 207127 (Drug)
结局指标
主要结局
Part 1: Rapid Virological Response (RVR)
时间窗: 4 weeks
Part 1: Rapid virological response (RVR), defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) \<25IU/mL at Week 4 of treatment
Part 2: Sustained Virological Response (SVR)
时间窗: From drug administration until 12 weeks after end of treatment, up to 52 weeks
Part 2: Sustained virological response (SVR), defined as HCV RNA \<25 IU/mL and undetectable at 12 weeks after end of treatment
Part 3 and 4: Sustained Virological Response (SVR)
时间窗: From drug administration until 12 weeks after end of treatment, up to 36 weeks
Part 3 and 4: Sustained virological response (SVR) defined as HCV RNA \<25IU/mL and undetectable at 12 weeks after end of treatment
次要结局
- Part 1: Time to Virological Response(From drug administration until end of drug administration, up to 4 weeks)
- Part 2: Time to Virological Response(From drug administration until end of drug administration, up to 40 weeks)
- Part 1 and 2: Plasma HCV RNA Level Not Detectable at Week 4(4 weeks)
- Part 2: Sustained Virological Response at 4 and 24 Weeks After End of Treatment(4 weeks and 24 weeks after the end of treatment, up to 64 weeks)
- Part 3 and 4: Plasma HCV RNA Level <25 IU/mL at Week 4 and 12 of Treatment(Week 4 and 12)
- Part 3 and 4: Sustained Virological Response (SVR) at 4 Weeks After End of Treatment(up to 28 weeks)