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Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care

23 septembre 2015 mis à jour par: Bristol-Myers Squibb

Parallel, Open-Label, Randomized Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of PSI-7977 in Combination With BMS-790052 With or Without Ribavirin in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotypes 1, 2, or 3

The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

350

Phase

  • Phase 2

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

  • Porto Rico
      • San Juan, Porto Rico, 00927
        • Local Institution
  • États-Unis
    • California
      • Coronado, California, États-Unis, 92118
        • Southern California Liver Centers
      • San Diego, California, États-Unis, 92105
        • Research and Education, Inc.
    • Colorado
      • Aurora, Colorado, États-Unis, 80045
        • University Of Colorado Denver & Hospital
    • Florida
      • Gainesville, Florida, États-Unis, 32610
        • University Of Florida Hepatology
      • Orlando, Florida, États-Unis, 32803
        • Orlando Immunology Center
      • South Miami, Florida, États-Unis, 33143
        • Miami Research Associates
    • Maryland
      • Baltimore, Maryland, États-Unis, 21202
        • Mercy Medical Center
      • Lutherville, Maryland, États-Unis, 21093
        • Johns Hopkins University
    • Michigan
      • Ann Arbor, Michigan, États-Unis, 48109
        • University of Michigan Health System
    • New York
      • Bronx, New York, États-Unis, 10468
        • Bronx Va Medical Center 3c Sub-J
      • New York, New York, États-Unis, 10021
        • Weill Cornell Medical College
    • Oklahoma
      • Tulsa, Oklahoma, États-Unis, 74104
        • Options Health Research, LLC
      • Tulsa, Oklahoma, États-Unis, 74135
        • Healthcare Research Consultants
    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19104
        • University of Pennsylvania
    • Texas
      • San Antonio, Texas, États-Unis, 78215
        • Alamo Medical Research
    • Virginia
      • Annandale, Virginia, États-Unis, 22003
        • Metropolitan Research
    • Wisconsin
      • Madison, Wisconsin, États-Unis, 53715
        • Dean Clinic

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 à 70 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Men and women, ages 18 to 70 years.
  • Participants infected with hepatitis C virus (HCV) genotype 1, 2, or 3, with no previous exposure to an interferon formulation (ie, interferon-alpha, pegylated interferon-alpha) ribavirin, or other HCV-specific direct-acting antiviral (including daclatasvir and PSI-7977).
  • Patients should have chronic hepatitis C genotype 1a, 1b, 2, or 3 as documented by: positive test results for anti-HCV antibody; HCV RNA; or a HCV genotype at least 6 months prior to screening, and HCV RNA and anti-HCV antibody at the time of screening.

Exclusion Criteria:

  • Evidence of a medical condition associate with chronic liver disease other than HCV.
  • History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis.
  • History of hemophilia.
  • History of torsade de pointes.
  • 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 enrollment.
  • History of gastrointestinal disease or surgical procedure (except cholecystectomy).
  • History of clinically significant cardiac disease.
  • Blood transfusion within 4 weeks prior to study drug administration.
  • Poor venous access.
  • Any other medical, psychiatric, and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study.

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: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Treatment A: PSI-7977 + Daclatasvir
Genotype 1a or 1b
Médicament: PSI-7977
Tablets, oral, 400 mg, once daily
Médicament: Daclatasvir
Tablets, oral, 60 mg, once daily
Autres noms:
  • BMS-790052
Expérimental: Treatment B: PSI-7977 + Daclatasvir
Genotype 2 or 3
Médicament: PSI-7977
Tablets, oral, 400 mg, once daily
Médicament: Daclatasvir
Tablets, oral, 60 mg, once daily
Autres noms:
  • BMS-790052
Expérimental: Treatment C: PSI-7977 + Daclatasvir
Genotype 1a or 1b
Médicament: PSI-7977
Tablets, oral, 400 mg, once daily
Médicament: Daclatasvir
Tablets, oral, 60 mg, once daily
Autres noms:
  • BMS-790052
Expérimental: Treatment D: PSI-7977 + Daclatasvir
Genotype 2 or 3
Médicament: PSI-7977
Tablets, oral, 400 mg, once daily
Médicament: Daclatasvir
Tablets, oral, 60 mg, once daily
Autres noms:
  • BMS-790052
Expérimental: Treatment E: PSI-7977 + Daclatasvir + Ribavirin
Genotype 1a or 1b
Médicament: PSI-7977
Tablets, oral, 400 mg, once daily
Médicament: Daclatasvir
Tablets, oral, 60 mg, once daily
Autres noms:
  • BMS-790052
Médicament: Ribavirin
Tablets, oral, 200 mg
Autres noms:
  • Copegus ®
Expérimental: Treatment F: PSI-7977 + Daclatasvir+ Ribavirin
Genotype 2 or 3
Médicament: PSI-7977
Tablets, oral, 400 mg, once daily
Médicament: Daclatasvir
Tablets, oral, 60 mg, once daily
Autres noms:
  • BMS-790052
Médicament: Ribavirin
Tablets, oral, 200 mg
Autres noms:
  • Copegus ®
Expérimental: Treatment G: PSI-7977 + Daclatasvir

Hepatitis C virus genotype 1, treatment-naive patients

Genotype 1a or 1b
Médicament: PSI-7977
Tablets, oral, 400 mg, once daily
Médicament: Daclatasvir
Tablets, oral, 60 mg, once daily
Autres noms:
  • BMS-790052
Expérimental: Treatment H: PSI-7977 + BMS-790052 + Ribavirin

Hepatitis C virus genotype 1, treatment-naive patients

Genotype 1a or 1b
Médicament: PSI-7977
Tablets, oral, 400 mg, once daily
Médicament: Daclatasvir
Tablets, oral, 60 mg, once daily
Autres noms:
  • BMS-790052
Médicament: Ribavirin
Tablets, oral, 200 mg
Autres noms:
  • Copegus ®
Expérimental: Treatment I: PSI-7977 + Daclatasvir

Patients who experienced telaprevir/boceprevir treatment failure

Genotype 1a or 1b
Médicament: PSI-7977
Tablets, oral, 400 mg, once daily
Médicament: Daclatasvir
Tablets, oral, 60 mg, once daily
Autres noms:
  • BMS-790052
Expérimental: Treatment J: PSI-7977 + Daclatasvir + Ribavirin

Patients who experienced telaprevir/boceprevir treatment failure

Genotype 1a or 1b
Médicament: PSI-7977
Tablets, oral, 400 mg, once daily
Médicament: Daclatasvir
Tablets, oral, 60 mg, once daily
Autres noms:
  • BMS-790052
Médicament: Ribavirin
Tablets, oral, 200 mg
Autres noms:
  • Copegus ®

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
Délai: Follow-up Week 12
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA <25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir.
Follow-up Week 12

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
Délai: Follow-up Week 24
SVR24 was defined as participant's hepatitis C virus RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 24. DCV=daclatasvir, SOF=sofosbuvir.
Follow-up Week 24
Percentage of Participants With Viral Breakthrough During the Treatment Period
Délai: First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)
Viral breakthrough is defined as any confirmed increase in viral load ≥1 log from nadir or any confirmed hepatitis C virus RNA levels ≥25 IU/mL on or after Week 8.
First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)
Percentage of Participants Who Experienced Viral Relapse During Follow-up Period
Délai: Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)
Viral relapse during follow-up is defined as any confirmed quantifiable hepatitis C virus (HCV) RNA ≥25 IU/mL with HCV RNA levels less than the lower limit of quantitation, target detected or target not detected, ie, HCV RNA <25 IU/mL at the end of treatment.
Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)
Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24
Délai: Baseline, Follow-up week 24
Change from baseline in log10 HCV RNA at scheduled sampling time.
Baseline, Follow-up week 24
Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy
Délai: First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)
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. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe.
First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)
Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period
Délai: AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks)
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. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe
AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Bristol-Myers Squibb

Collaborateurs

Pharmasset

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

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 juin 2011

Achèvement primaire (Réel)

1 janvier 2013

Achèvement de l'étude (Réel)

1 octobre 2013

Dates d'inscription aux études

Première soumission

23 mai 2011

Première soumission répondant aux critères de contrôle qualité

24 mai 2011

Première publication (Estimation)

25 mai 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

23 octobre 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

23 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

  • AI444-040

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 .

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