Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV (ALLY 3)
2015년 9월 29일 업데이트: 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
연구 개요
연구 유형
중재적
등록 (실제)
173
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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La Jolla, California, 미국, 92037
- Scripps Clinic
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Los Angeles, California, 미국, 90057
- National Research Institute
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Los Angeles, California, 미국, 90036
- Peter J Ruane Md Inc
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Los Angeles, California, 미국, 90069
- Anthony M. Mills Md Inc
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Pasadena, California, 미국, 91105
- Huntington Medical Research Institutes
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San Diego, California, 미국, 92123
- Medical Associates Research Group
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San Diego, California, 미국, 92114
- Precision Research Institute, LLC
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San Francisco, California, 미국, 94115
- Quest Clinical Research
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Florida
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Deland, Florida, 미국, 32720
- Midland Florida Clinical Research Center, LLC
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Gainesville, Florida, 미국, 32610
- University of Florida Hepatology Research
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Georgia
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Atlanta, Georgia, 미국, 30308
- Atlanta Gastroenterology Associates
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Marietta, Georgia, 미국, 30060
- Gastrointestinal Specialists of Georgia
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Illinois
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Downers Grove, Illinois, 미국, 60515
- DuPage Medical Group
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Maryland
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Baltimore, Maryland, 미국, 21202
- Mercy Medical Center, Inc.
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Baltimore, Maryland, 미국, 21229
- Digestive Disease Associates, P.A.
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Missouri
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Kansas City, Missouri, 미국, 64131
- Kansas City Research Institute
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New Mexico
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Santa Fe, New Mexico, 미국, 87505
- Southwest CARE Center
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New York
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Manhasset, New York, 미국, 11030
- North Shore University Hospital
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Poughkeepsie, New York, 미국, 12601
- Premier Medical Group of the Hudson Valley, PC
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North Carolina
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Asheville, North Carolina, 미국, 28801
- Asheville Gastroenterology Associates, PA
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Winston-salem, North Carolina, 미국, 27103
- Digestive Health Specialists, PA
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Pennsylvania
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Perkasie, Pennsylvania, 미국, 18944
- Main Line Gastroenterology Associates Pc
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Pittsburgh, Pennsylvania, 미국, 15213
- Center For Liver Diseases
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Tennessee
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Germantown, Tennessee, 미국, 38138
- Gastro One
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Texas
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Arlington, Texas, 미국, 76012
- Texas Clinical Research Institute, LLC
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San Antonio, Texas, 미국, 78215
- American Research Corporation
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Utah
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Murray, Utah, 미국, 84123
- Clinical Research Centers Of America
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Salt Lake City, Utah, 미국, 84106
- Lifetree Clinical Research
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Virginia
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Falls Church, Virginia, 미국, 22042
- Inova Fairfax Hospital
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Washington
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Seattle, Washington, 미국, 98101
- Virginia Mason Medical Center
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San Juan, 푸에르토 리코, 00927
- Fundacion De Investigacion de Diego
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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다른 이름들:
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실험적: 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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다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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)
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 1월 1일
기본 완료 (실제)
2014년 9월 1일
연구 완료 (실제)
2014년 12월 1일
연구 등록 날짜
최초 제출
2014년 1월 9일
QC 기준을 충족하는 최초 제출
2014년 1월 9일
처음 게시됨 (추정)
2014년 1월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 10월 1일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 9월 29일
마지막으로 확인됨
2015년 9월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- AI444-218
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .