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
調査の概要
研究の種類
介入
入学 (実際)
173
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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La Jolla、California、アメリカ、92037
- Scripps Clinic
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Los Angeles、California、アメリカ、90057
- National Research Institute
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Los Angeles、California、アメリカ、90036
- Peter J Ruane Md Inc
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Los Angeles、California、アメリカ、90069
- Anthony M. Mills Md Inc
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Pasadena、California、アメリカ、91105
- Huntington Medical Research Institutes
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San Diego、California、アメリカ、92123
- Medical Associates Research Group
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San Diego、California、アメリカ、92114
- Precision Research Institute, LLC
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San Francisco、California、アメリカ、94115
- Quest Clinical Research
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Florida
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Deland、Florida、アメリカ、32720
- Midland Florida Clinical Research Center, LLC
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Gainesville、Florida、アメリカ、32610
- University of Florida Hepatology Research
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Georgia
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Atlanta、Georgia、アメリカ、30308
- Atlanta Gastroenterology Associates
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Marietta、Georgia、アメリカ、30060
- Gastrointestinal Specialists of Georgia
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Illinois
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Downers Grove、Illinois、アメリカ、60515
- DuPage Medical Group
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Maryland
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Baltimore、Maryland、アメリカ、21202
- Mercy Medical Center, Inc.
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Baltimore、Maryland、アメリカ、21229
- Digestive Disease Associates, P.A.
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Missouri
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Kansas City、Missouri、アメリカ、64131
- Kansas City Research Institute
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New Mexico
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Santa Fe、New Mexico、アメリカ、87505
- Southwest CARE Center
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New York
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Manhasset、New York、アメリカ、11030
- North Shore University Hospital
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Poughkeepsie、New York、アメリカ、12601
- Premier Medical Group of the Hudson Valley, PC
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North Carolina
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Asheville、North Carolina、アメリカ、28801
- Asheville Gastroenterology Associates, PA
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Winston-salem、North Carolina、アメリカ、27103
- Digestive Health Specialists, PA
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Pennsylvania
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Perkasie、Pennsylvania、アメリカ、18944
- Main Line Gastroenterology Associates Pc
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Pittsburgh、Pennsylvania、アメリカ、15213
- Center For Liver Diseases
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Tennessee
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Germantown、Tennessee、アメリカ、38138
- Gastro One
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Texas
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Arlington、Texas、アメリカ、76012
- Texas Clinical Research Institute, LLC
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San Antonio、Texas、アメリカ、78215
- American Research Corporation
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Utah
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Murray、Utah、アメリカ、84123
- Clinical Research Centers Of America
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Salt Lake City、Utah、アメリカ、84106
- Lifetree Clinical Research
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Virginia
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Falls Church、Virginia、アメリカ、22042
- Inova Fairfax Hospital
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Washington
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Seattle、Washington、アメリカ、98101
- Virginia Mason Medical Center
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San Juan、プエルトリコ、00927
- Fundacion De Investigacion de Diego
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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他の名前：
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実験的：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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他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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)
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2014年1月1日
一次修了 (実際)
2014年9月1日
研究の完了 (実際)
2014年12月1日
試験登録日
最初に提出
2014年1月9日
QC基準を満たした最初の提出物
2014年1月9日
最初の投稿 (見積もり)
2014年1月10日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年10月1日
QC基準を満たした最後の更新が送信されました
2015年9月29日
最終確認日
2015年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- AI444-218
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。