Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV (ALLY 3)
29 septembre 2015 mis à jour par: 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
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
173
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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San Juan, Porto Rico, 00927
- Fundacion De Investigacion de Diego
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California
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La Jolla, California, États-Unis, 92037
- Scripps Clinic
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Los Angeles, California, États-Unis, 90057
- National Research Institute
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Los Angeles, California, États-Unis, 90036
- Peter J Ruane Md Inc
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Los Angeles, California, États-Unis, 90069
- Anthony M. Mills Md Inc
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Pasadena, California, États-Unis, 91105
- Huntington Medical Research Institutes
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San Diego, California, États-Unis, 92123
- Medical Associates Research Group
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San Diego, California, États-Unis, 92114
- Precision Research Institute, LLC
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San Francisco, California, États-Unis, 94115
- Quest Clinical Research
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Florida
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Deland, Florida, États-Unis, 32720
- Midland Florida Clinical Research Center, LLC
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Gainesville, Florida, États-Unis, 32610
- University of Florida Hepatology Research
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Georgia
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Atlanta, Georgia, États-Unis, 30308
- Atlanta Gastroenterology Associates
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Marietta, Georgia, États-Unis, 30060
- Gastrointestinal Specialists of Georgia
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Illinois
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Downers Grove, Illinois, États-Unis, 60515
- DuPage Medical Group
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Maryland
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Baltimore, Maryland, États-Unis, 21202
- Mercy Medical Center, Inc.
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Baltimore, Maryland, États-Unis, 21229
- Digestive Disease Associates, P.A.
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Missouri
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Kansas City, Missouri, États-Unis, 64131
- Kansas City Research Institute
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New Mexico
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Santa Fe, New Mexico, États-Unis, 87505
- Southwest CARE Center
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New York
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Manhasset, New York, États-Unis, 11030
- North Shore University Hospital
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Poughkeepsie, New York, États-Unis, 12601
- Premier Medical Group of the Hudson Valley, PC
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North Carolina
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Asheville, North Carolina, États-Unis, 28801
- Asheville Gastroenterology Associates, PA
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Winston-salem, North Carolina, États-Unis, 27103
- Digestive Health Specialists, PA
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Pennsylvania
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Perkasie, Pennsylvania, États-Unis, 18944
- Main Line Gastroenterology Associates Pc
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Pittsburgh, Pennsylvania, États-Unis, 15213
- Center For Liver Diseases
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Tennessee
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Germantown, Tennessee, États-Unis, 38138
- Gastro One
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Texas
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Arlington, Texas, États-Unis, 76012
- Texas Clinical Research Institute, LLC
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San Antonio, Texas, États-Unis, 78215
- American Research Corporation
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Utah
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Murray, Utah, États-Unis, 84123
- Clinical Research Centers Of America
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Salt Lake City, Utah, États-Unis, 84106
- Lifetree Clinical Research
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Virginia
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Falls Church, Virginia, États-Unis, 22042
- INOVA Fairfax Hospital
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Washington
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Seattle, Washington, États-Unis, 98101
- Virginia Mason Medical Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Autres noms:
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Expérimental: 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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Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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)
Délai: 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)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2014
Achèvement primaire (Réel)
1 septembre 2014
Achèvement de l'étude (Réel)
1 décembre 2014
Dates d'inscription aux études
Première soumission
9 janvier 2014
Première soumission répondant aux critères de contrôle qualité
9 janvier 2014
Première publication (Estimation)
10 janvier 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
1 octobre 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 septembre 2015
Dernière vérification
1 septembre 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AI444-218
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .