A Phase II, Randomized, Double-Blind Study to Evaluate the Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin in Subjects With Genotype 1 Chronic Hepatitis C Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 81
- 主要终点
- Percentage of participants experiencing dose-limiting toxicities (DLTs)
研究概览
简要总结
This study will assess short term safety, antiviral activity and pharmacokinetics (PK) of IDX184 in combination with Peg-interferon (Peg-IFN)/Ribavirin (RBV) in participants with hepatitis C virus (HCV) genotype (GT) 1 infection. These data will guide dose selection for future, longer term studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Has documented chronic HCV GT1 infection
- •Agrees to use of double-barrier contraception and males agree not to donate sperm from the first dose of study therapy through at least 6 months after the final dose of study therapy
排除标准
- •Has received previous antiviral treatment for HCV infection
- •Has cirrhosis or decompensated liver disease
- •Is pregnant or breastfeeding
- •Is co-infected with hepatitis B virus (e.g., hepatitis B surface antigen [HBsAg] positive) and/or human immunodeficiency virus (HIV)
- •Has clinically significant concomitant disease
研究组 & 干预措施
IDX184 100 mg BID + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo twice daily (BID) in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.
干预措施: IDX184 (Drug)
IDX184 50 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo once daily (QD) in combination with Peg-IFN/RBV on Days 14-28 and Peg-IFN/RBV on Days 14-28.
干预措施: IDX184 (Drug)
IDX184 50 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo once daily (QD) in combination with Peg-IFN/RBV on Days 14-28 and Peg-IFN/RBV on Days 14-28.
干预措施: Placebo (Drug)
IDX184 50 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo once daily (QD) in combination with Peg-IFN/RBV on Days 14-28 and Peg-IFN/RBV on Days 14-28.
干预措施: Peginterferon alfa-2a (Peg-IFN) (Biological)
IDX184 50 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo once daily (QD) in combination with Peg-IFN/RBV on Days 14-28 and Peg-IFN/RBV on Days 14-28.
干预措施: Ribavirin (RBV) (Drug)
IDX184 100 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.
干预措施: IDX184 (Drug)
IDX184 100 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.
干预措施: Placebo (Drug)
IDX184 100 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.
干预措施: Peginterferon alfa-2a (Peg-IFN) (Biological)
IDX184 100 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.
干预措施: Ribavirin (RBV) (Drug)
IDX184 100 mg BID + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo twice daily (BID) in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.
干预措施: Placebo (Drug)
IDX184 100 mg BID + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo twice daily (BID) in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.
干预措施: Peginterferon alfa-2a (Peg-IFN) (Biological)
IDX184 100 mg BID + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo twice daily (BID) in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.
干预措施: Ribavirin (RBV) (Drug)
IDX184 150 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 150 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
干预措施: IDX184 (Drug)
IDX184 150 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 150 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
干预措施: Placebo (Drug)
IDX184 150 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 150 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
干预措施: Peginterferon alfa-2a (Peg-IFN) (Biological)
IDX184 150 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 150 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
干预措施: Ribavirin (RBV) (Drug)
IDX184 200 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
干预措施: IDX184 (Drug)
IDX184 200 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
干预措施: Placebo (Drug)
IDX184 200 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
干预措施: Peginterferon alfa-2a (Peg-IFN) (Biological)
IDX184 200 mg QD + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
干预措施: Ribavirin (RBV) (Drug)
IDX184 200 mg BID + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 200 mg or placebo BID in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
干预措施: IDX184 (Drug)
IDX184 200 mg BID + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 200 mg or placebo BID in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
干预措施: Placebo (Drug)
IDX184 200 mg BID + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 200 mg or placebo BID in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
干预措施: Peginterferon alfa-2a (Peg-IFN) (Biological)
IDX184 200 mg BID + Peg-IFN/RBV
Participants randomized 4:1 (active:placebo) to receive IDX184 200 mg or placebo BID in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
干预措施: Ribavirin (RBV) (Drug)
结局指标
主要结局
Percentage of participants experiencing dose-limiting toxicities (DLTs)
时间窗: Up to 28 days
Change in HCV ribonucleic acid (RNA) level from Baseline to Day 15
时间窗: Baseline and Day 15
Percentage of participants experiencing adverse events (AEs)
时间窗: Up to 28 days
Percentage of participants experiencing Grade 1-4 laboratory abnormalities
时间窗: Up to 28 days
Percentage of participants experiencing serious adverse events (SAEs)
时间窗: Up to 28 days
次要结局
- Time to maximum concentration (Tmax)(Up to 28 days)
- Trough concentration (Ctrough)(Up to 28 days)
- Maximum concentration (Cmax)(Up to 28 days)
- Change in alanine aminotransferase (ALT) level from Baseline to Day 15(Baseline and Day 15)
- Observed terminal half-life (Thalf)(Up to 28 days)
- Change in HCV RNA level from Baseline to Day 28(Baseline and Day 28)
- Percentage of participants with undetectable HCV RNA at Day 15(Day 15)
- Change in ALT level from Baseline to Day 28(Baseline and Day 28)
- Area under the drug concentration-time curve (AUC) from time 0 to last measurable concentration (AUC0-t)(Up to 28 days)
- AUC from time zero to infinity (AUC0-~)(Up to 28 days)
- Percentage of participants with undetectable HCV RNA at Day 28(Day 28)
- Percentage of participants experiencing virologic breakthrough while on study therapy(Up to 28 days)