Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV (ALLY 3)
2015年9月29日 更新者：Bristol-Myers Squibb
A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naive and Treatment Experienced Subjects With Genotype 3 Chronic Hepatitis C Infection
To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus (HCV) Genotype 3 infection
研究概览
研究类型
介入性
注册 (实际的)
173
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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San Juan、波多黎各、00927
- Fundacion De Investigacion de Diego
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California
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La Jolla、California、美国、92037
- Scripps Clinic
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Los Angeles、California、美国、90057
- National Research Institute
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Los Angeles、California、美国、90036
- Peter J Ruane Md Inc
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Los Angeles、California、美国、90069
- Anthony M. Mills Md Inc
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Pasadena、California、美国、91105
- Huntington Medical Research Institutes
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San Diego、California、美国、92123
- Medical Associates Research Group
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San Diego、California、美国、92114
- Precision Research Institute, LLC
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San Francisco、California、美国、94115
- Quest Clinical Research
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Florida
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Deland、Florida、美国、32720
- Midland Florida Clinical Research Center, LLC
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Gainesville、Florida、美国、32610
- University of Florida Hepatology Research
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Georgia
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Atlanta、Georgia、美国、30308
- Atlanta Gastroenterology Associates
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Marietta、Georgia、美国、30060
- Gastrointestinal Specialists of Georgia
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Illinois
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Downers Grove、Illinois、美国、60515
- DuPage Medical Group
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Maryland
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Baltimore、Maryland、美国、21202
- Mercy Medical Center, Inc.
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Baltimore、Maryland、美国、21229
- Digestive Disease Associates, P.A.
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Missouri
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Kansas City、Missouri、美国、64131
- Kansas City Research Institute
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New Mexico
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Santa Fe、New Mexico、美国、87505
- Southwest CARE Center
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New York
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Manhasset、New York、美国、11030
- North Shore University Hospital
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Poughkeepsie、New York、美国、12601
- Premier Medical Group of the Hudson Valley, PC
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North Carolina
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Asheville、North Carolina、美国、28801
- Asheville Gastroenterology Associates, PA
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Winston-salem、North Carolina、美国、27103
- Digestive Health Specialists, PA
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Pennsylvania
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Perkasie、Pennsylvania、美国、18944
- Main Line Gastroenterology Associates Pc
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Pittsburgh、Pennsylvania、美国、15213
- Center For Liver Diseases
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Tennessee
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Germantown、Tennessee、美国、38138
- Gastro One
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Texas
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Arlington、Texas、美国、76012
- Texas Clinical Research Institute, LLC
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San Antonio、Texas、美国、78215
- American Research Corporation
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Utah
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Murray、Utah、美国、84123
- Clinical Research Centers Of America
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Salt Lake City、Utah、美国、84106
- Lifetree Clinical Research
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Virginia
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Falls Church、Virginia、美国、22042
- INOVA Fairfax Hospital
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Washington
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Seattle、Washington、美国、98101
- Virginia Mason Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Key Inclusion Criteria:
- Subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
- Subjects chronically infected with hepatitis C virus (HCV) genotype 3
- Subjects who are HCV treatment-naive
- Subjects who are HCV treatment-experienced (previous exposure to non-structural 5A inhibitors is prohibited)
- HCV RNA ≥10,000 IU/mL at screening
Key Exclusion Criteria:
- HCV Genotypes other than genotype-3 infection; mixed genotype infections are not permitted
- Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
- Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening
- Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed)
- Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：A1:Daclatasvir + Sofosbuvir in treatment-naive subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
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其他名称：
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实验性的：A2:Daclatasvir + Sofosbuvir in treatment-experienced subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
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其他名称：
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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 |
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Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
大体时间：Week 12 (Follow-up period)
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SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, TD or TND at follow-up Week 12. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
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Week 12 (Follow-up period)
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Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
大体时间：Week 12 (Follow-up period)
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SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Week 12 (Follow-up period)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)
大体时间：Week 4
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RVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Week 4
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Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND)
大体时间：Week 12
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cEVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Week 12
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Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND)
大体时间：Up to the end of treatment (up to 24 weeks)
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EOTR were defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at end of treatment.
HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Up to the end of treatment (up to 24 weeks)
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Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND)
大体时间：Week 1, 2, 6, 8 (treatment period)
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Percentage of participants who achieved HCV RNA <LLOQ, TND was determined (LLOQ: 25 IU/mL).
HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Week 1, 2, 6, 8 (treatment period)
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Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)
大体时间：Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)
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Percentage of participants who achieved HCV RNA <LLOQ,TD or TND was determined (LLOQ: 25 IU/mL).
HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)
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Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)
大体时间：Baseline, Week 12 (Follow-up period)
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SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie. 25 IU/mL, target detected or target not detected at follow-up Week 12. Cirrhosis was considered a negative predictor of SVR in participants treated with an interferon formulation or ribavirin.
Presence or absence of cirrhosis was determined at baseline and follow-up Week 12 in the participants to evaluate the post-treatment relapse.
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Baseline, Week 12 (Follow-up period)
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Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12)
大体时间：Week 12 (Follow-up period)
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Participants categorized into 2 genotypes (CC and non-CC) based on SNPs in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus (HCV) RNA levels below lower limit of quantitation (LLOQ) below target detected or target not detected at follow-up Week 12 (LLOQ: 25 IU/mL).
HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Week 12 (Follow-up period)
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Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)
大体时间：From Day 1 first dose to last dose plus 7 days
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AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment.
SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
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From Day 1 first dose to last dose plus 7 days
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Kowdley KV, Nelson DR, Lalezari JP, Box T, Gitlin N, Poleynard G, Rabinovitz M, Ravendhran N, Sheikh AM, Siddique A, Bhore R, Noviello S, Rana K. On-treatment HCV RNA as a predictor of sustained virological response in HCV genotype 3-infected patients treated with daclatasvir and sofosbuvir. Liver Int. 2016 Nov;36(11):1611-1618. doi: 10.1111/liv.13165. Epub 2016 Jun 16.
- Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, Freilich BF, Younes ZH, Harlan W, Ghalib R, Oguchi G, Thuluvath PJ, Ortiz-Lasanta G, Rabinovitz M, Bernstein D, Bennett M, Hawkins T, Ravendhran N, Sheikh AM, Varunok P, Kowdley KV, Hennicken D, McPhee F, Rana K, Hughes EA; ALLY-3 Study Team. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology. 2015 Apr;61(4):1127-35. doi: 10.1002/hep.27726. Epub 2015 Mar 10.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年1月1日
初级完成 (实际的)
2014年9月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2014年1月9日
首先提交符合 QC 标准的
2014年1月9日
首次发布 (估计)
2014年1月10日
研究记录更新
最后更新发布 (估计)
2015年10月1日
上次提交的符合 QC 标准的更新
2015年9月29日
最后验证
2015年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.