A Phase II/III Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects With Chronic Hepatitis C Virus Infection With Advanced Cirrhosis and Child-Pugh (CP)-B Hepatic Insufficiency
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Percentage of Participants Achieving Sustained Viral Response 12 Weeks After Completing Study Therapy (SVR12)
研究概览
简要总结
This study is being done to evaluate the efficacy and safety of the drug combination grazoprevir (GZR; MK-5172) + elbasvir (EBR; MK-8742) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infection and who have cirrhosis and Child-Pugh (CP) score 7-9 moderate hepatic insufficiency (CP-B). The primary hypothesis is that the percentage of HCV-infected participants with hepatic insufficiency (the CP-B population) achieving sustained viral response (SVR) 12 weeks after the end of all treatment (SVR12) will be greater than 60%. Additionally, ten non-cirrhotic (NC) HCV-infected GT1 participants will also be given GZR + EBR at the beginning of the study; this will be done for the purpose of collecting plasma pharmacokinetic (PK) data in HCV GT1-infected participants who do not have hepatic insufficiency.
详细描述
The study will be conducted sequentially in 3 Parts. Each participant will participate in only one Part.
Participants will be enrolled in either Part A, Part B, or Part C:
- Part A: CP-B participants will receive GZR 50 mg+ EBR 50 mg; NC participants will receive GZR 100 mg/EBR 50 mg.
- Part B: CP-B participants will receive GZR 100 mg + EBR 50 mg.
- Part C: CP-B participants will receive either GZR 50 mg or 100 mg + EBR 50 mg. Study progression from Part A to Part B and from Part B to Part C will be based upon a review of safety and efficacy in Parts A and B, respectively. Depending upon safety and efficacy in Part A, the study may progress directly from Part A to Part C using GZR 50 mg + EBR 50 mg, without performing Part B.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Part A: CP-B GZR 50 mg + EBR 50 mg
CP-B participants take GZR 50 mg + EBR 50 mg once daily (q.d.) by mouth for 12 weeks.
干预措施: Grazoprevir (Drug)
Part A: CP-B GZR 50 mg + EBR 50 mg
CP-B participants take GZR 50 mg + EBR 50 mg once daily (q.d.) by mouth for 12 weeks.
干预措施: Elbasvir (Drug)
Part A: NC GZR 100 mg + EBR 50 mg
NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
干预措施: Grazoprevir (Drug)
Part A: NC GZR 100 mg + EBR 50 mg
NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
干预措施: Elbasvir (Drug)
Part A: NC GZR 100 mg + EBR 50 mg
NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
干预措施: MK-5172A (Drug)
Part B: CP-B GZR 100 mg + EBR 50 mg
CP-B participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
干预措施: Grazoprevir (Drug)
Part B: CP-B GZR 100 mg + EBR 50 mg
CP-B participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
干预措施: Elbasvir (Drug)
Part B: CP-B GZR 100 mg + EBR 50 mg
CP-B participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
干预措施: MK-5172A (Drug)
Part C: CP-B GZR 50 mg or 100 mg + EBR 50 mg
CP-B participants take GZR 50 mg or GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks (GZR dose chosen based on results of Part A CP-B arm).
干预措施: Grazoprevir (Drug)
Part C: CP-B GZR 50 mg or 100 mg + EBR 50 mg
CP-B participants take GZR 50 mg or GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks (GZR dose chosen based on results of Part A CP-B arm).
干预措施: Elbasvir (Drug)
Part C: CP-B GZR 50 mg or 100 mg + EBR 50 mg
CP-B participants take GZR 50 mg or GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks (GZR dose chosen based on results of Part A CP-B arm).
干预措施: MK-5172A (Drug)
结局指标
主要结局
Percentage of Participants Achieving Sustained Viral Response 12 Weeks After Completing Study Therapy (SVR12)
时间窗: Week 24
SVR12 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) levels below the lower limit of quantification (LLoQ) 12 weeks after completing study therapy. HCV RNA was measured with the COBAS™ AmpliPrep/COBAS™ Taqman™ HCV Test, v2.0 ® assay which has a LLoQ of 15 IU/mL and a limit of detection of 15 IU/mL.
Number of Participants Experiencing an Adverse Event (AE) During Treatment and First 14 Follow-up Days
时间窗: Up to 14 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Number of Participants Discontinuing Study Drug Due to an AE
时间窗: Up to 12 weeks
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
次要结局
- Percentage of Participants With HCV RNA <LLoQ at Weeks 2, 4, and 12(Weeks 2, 4, and 12)
- Mean Change From Baseline in Model for End-Stage Liver Disease (MELD) Scores in CP-B Participants(Baseline and Weeks 12, 24, and 36)
- Percentage of Participants Achieving Sustained Viral Response 4 Weeks After Completing Study Therapy (SVR4)(Week 16)
- Percentage of Participants Achieving Sustained Viral Response 24 Weeks After Completing Study Therapy (SVR24)(Week 36)
- Percentage of Participants With HCV RNA Undetectable at Weeks 2, 4, and 12(Week 2, 4, and 12)