A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1b Infection (PEARL-III)
A Randomized, Double-blind, Controlled Study to Evaluate the Efficacy and Safety of the Combination of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With and Without Ribavirin (RBV) in Treatment-Naive Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection (PEARL-III)
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 第三阶段
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
- Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)
- Subject has never received antiviral treatment for hepatitis C infection
- No evidence of liver cirrhosis
Exclusion Criteria:
- Significant liver disease with any cause other than HCV as the primary cause
- Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
- Positive screen for drugs or alcohol
- Significant sensitivity to any drug
- Use of contraindicated medications within 2 weeks of dosing
- Abnormal laboratory tests
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：ABT-450/r/ABT-267 和 ABT-333，加上 RBV
ABT-450/r/ABT-267（150 mg/100 mg/25 mg，每天一次）和 ABT-333（250 mg，每天两次），加上基于体重的 RBV（剂量为 1,000 或 1,200 mg，每天两次） 12周
|
药片; ABT-450 与利托那韦和 ABT-267 共同配制，ABT-333 片剂
其他名称：
胶囊
|
|
实验性的：ABT-450/r/ABT-267 和 ABT-333，加上安慰剂 RBV
ABT-450/r/ABT-267（150 毫克/100 毫克/25 毫克每天一次）和 ABT-333（250 毫克每天两次）持续 12 周加上安慰剂 RBV（每天两次）持续 12 周
|
药片; ABT-450 与利托那韦和 ABT-267 共同配制，ABT-333 片剂
其他名称：
胶囊
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analyses of Each Treatment Arm Compared to Historical Rate
大体时间：12 weeks after last dose of study drug
|
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL. The primary efficacy endpoints were noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b infection treated with telaprevir and peginterferon/RBV (pegIFN). |
12 weeks after last dose of study drug
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
治疗结束时血红蛋白降至正常下限 (LLN) 以下的参与者百分比
大体时间：基线（第 1 天）和第 12 周（治疗结束）
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血红蛋白从基线时大于或等于正常下限 (≥ LLN) 下降到治疗结束时 < LLN 的参与者百分比。
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基线（第 1 天）和第 12 周（治疗结束）
|
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治疗期间出现病毒学失败的参与者百分比
大体时间：基线（第 1 天）和治疗第 1、2、4、6、8、10 和 12 周
|
治疗期间的病毒学失败定义为反弹（在治疗期间 HCV RNA < LLOQ 后确认的 HCV RNA 大于或等于定量下限 [≥ LLOQ]，或确认 HCV RNA 从基线后的最低值增加 [连续 2 次 HCV在治疗期间的任何时间点，RNA 测量值 > 1 log10 IU/mL 以上基线后最低值]，或未能抑制（HCV RNA ≥ LLOQ 在治疗期间持续至少 6 周 [≥ 36 天] 的治疗）。
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基线（第 1 天）和治疗第 1、2、4、6、8、10 和 12 周
|
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Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Noninferiority Analysis of ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV Compared With ABT-450/r/ABT-267 and ABT-333, Plus RBV
大体时间：12 weeks after last dose of study drug
|
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The secondary endpoint was the noninferiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment who received ABT-450/r/ABT-267 and ABT-333, plus placebo RBV compared with those who received ABT-450/r/ABT-267 and ABT-333, plus RBV. |
12 weeks after last dose of study drug
|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment; Superiority Analyses of Each Treatment Arm Compared to Historical Rate
大体时间：12 weeks after last dose of study drug
|
The percentage of participants with sustained virologic response (plasma HCV RNA less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The secondary efficacy endpoints were superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm (ABT-450/r/ABT-267 and ABT-333, plus either placebo RBV or RBV) compared with the historical control rate for noncirrhotic, treatment-naïve participants with HCV GT1b treated with telaprevir and pegIFN/RBV. |
12 weeks after last dose of study drug
|
|
Percentage of Participants With Virologic Relapse After Treatment
大体时间：Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-treatment)
|
Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period.
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Between End of Treatment (Week 12) and Post-treatment (up to Week 12 Post-treatment)
|
合作者和调查者
出版物和有用的链接
一般刊物
- Feld JJ, Bernstein DE, Younes Z, Vlierberghe HV, Larsen L, Tatsch F, Ferenci P. Ribavirin dose management in HCV patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin. Liver Int. 2018 Sep;38(9):1571-1575. doi: 10.1111/liv.13708. Epub 2018 Mar 14.
- Ferenci P, Bernstein D, Lalezari J, Cohen D, Luo Y, Cooper C, Tam E, Marinho RT, Tsai N, Nyberg A, Box TD, Younes Z, Enayati P, Green S, Baruch Y, Bhandari BR, Caruntu FA, Sepe T, Chulanov V, Janczewska E, Rizzardini G, Gervain J, Planas R, Moreno C, Hassanein T, Xie W, King M, Podsadecki T, Reddy KR; PEARL-III Study; PEARL-IV Study. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med. 2014 May 22;370(21):1983-92. doi: 10.1056/NEJMoa1402338. Epub 2014 May 4.
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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