A Phase 3 Clinical Trial to Study Short Duration Versus Standard Response-Guided Therapy With MK-3034 (SCH 503034)/Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Subjects With Chronic HCV Genotype 1 in Asia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 257
- 主要终点
- Percentage of Participants With Undetectable HCV RNA Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm]
研究概览
简要总结
The purpose of this study is to estimate the difference in the efficacy between a 16-week treatment regimen of boceprevir (BOC) in combination with peg-intron alpha 2b (P) plus ribavirin (R) (BOC + PR) and a 28-week treatment regimen of BOC + PR in previously untreated participants with chronic hepatitis C (CHC) genotype 1 in Asia who achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA).
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
- •weigh ≥ 40 kg and ≤ 125 kg
- •have CHC genotype 1 infection
- •has had a liver biopsy or non-invasive liver fibrosis test that shows no evidence of cirrhosis and hepatocellular carcinoma
- •must agree that the participant and the participant's partner will each use acceptable methods of contraception for at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations (for a female participant who is of childbearing potential or male participant with female sexual partner who is of childbearing potential)
排除标准
- •participates in any other interventional clinical trial within 30 days of the screening visit in this trial or intends to participate in another interventional clinical trial during participation in this trial
- •is co-infected with human immunodeficiency virus (HIV) or hepatitis B virus
- •has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis
- •has evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy
- •has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC
- •has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years
- •has been previously treated with an interferon or ribavirin regimen or HCV direct acting anti-viral regimen, or treated for hepatitis C with any investigational medication
- •taking/plans to take significant inducers of inhibitors of Cytochrome P450 3A4 (CYP3A4) substrates 2 weeks prior to start of study medications, or herbal supplements, including but not limited to St. John's Wort 2 weeks prior to start of study medications (Day 1)
- •has pre-existing psychiatric condition(s)
- •has a clinical diagnosis of substance abuse
- •has any known medical condition that could interfere with the participation in and completion of the trial including immunologically-mediated disease, chronic pulmonary disease, or current or history of any clinically significant cardiac abnormalities/dysfunction
- •is pregnant or nursing (for female participant) or female partner intends to become pregnant (for male participant)
研究组 & 干预措施
Arm 1: 16-week Treatment Arm
All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
干预措施: Boceprevir (Drug)
Arm 1: 16-week Treatment Arm
All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
干预措施: Peg-interferon alfa-2b (Biological)
Arm 1: 16-week Treatment Arm
All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
干预措施: Ribavirin (Drug)
Arm 2: 28-week Treatment Arm
All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
干预措施: Boceprevir (Drug)
Arm 2: 28-week Treatment Arm
All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
干预措施: Peg-interferon alfa-2b (Biological)
Arm 2: 28-week Treatment Arm
All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
干预措施: Ribavirin (Drug)
Arm 3: 48-week Treatment Arm
All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
干预措施: Boceprevir (Drug)
Arm 3: 48-week Treatment Arm
All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
干预措施: Peg-interferon alfa-2b (Biological)
Arm 3: 48-week Treatment Arm
All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable HCV RNA) or allocation to Arm 3 (participants with detectable HCV RNA). After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants With Undetectable HCV RNA Who Achieve Sustained Viral Response at Follow-up Week 12 (SVR12) [16-Week Arm vs. 28-Week Arm]
时间窗: Follow-up Week (FW) 12 (up to 40 weeks)
SVR12 was declared when participants who had undetectable HCV RNA (HCV RNA \< Lower Limit of Quantification \[LLoQ\]) after the 12-week lead-in also had undetectable HCV RNA 12 weeks after completing their assigned BOC treatment regimen. The Roche COBAS™ Taqman™ automated HCV test (v2.0 assay) used in this study has a LLoQ of 15 IU/mL.
次要结局
- Percentage of Participants With Undetectable HCV RNA Across Treatment(TW4, TW8, and TW12)
- Percentage of Participants Achieving SVR12 Among Participants With Undetectable HCV RNA Across Treatment(TW4, TW8, and TW12)
- Percentage of Participants With Relapse(From EOT to FW12 (up to 12 weeks))
- Percentage of Participants With Neutropenia(Up to 60 weeks)
- Percentage of Participants With Anemia(Up to 60 weeks)
- Percentage of Participants With Dose Discontinuation Due to Adverse Events (AEs)(From TW1 through TW48)
- Percentage of Participants With Treatment-Related Serious AEs (SAEs)(Up to 60 weeks)