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Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications

26 aprile 2017 aggiornato da: Bristol-Myers Squibb

Open-Label, Multiple-Dose, Dose Escalation Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Coadministration of BMS-650032, BMS-790052, and BMS-791325 When Administered for 24 or 12 Weeks in Treatment-Naïve Subjects Infected With Hepatitis C Virus Genotype 1

The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA < LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 & Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null responders to pegIFN/ribavirin

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

IND numbers: 79,599; 101,943

Tipo di studio

Interventistico

Iscrizione (Effettivo)

320

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Francia
      • Clichy Cedex, Francia, 92118
        • Local Institution
      • Creteil Cedex, Francia, 9410
        • Local Institution
      • Limoges, Francia, 87042
        • Local Institution
      • Marseille Cedex 08, Francia, 13285
        • Local Institution
      • Paris Cedex 14, Francia, 75679
        • Local Institution
  • Porto Rico
      • San Juan, Porto Rico, 00927
        • Fundacion de Investigacion de Diego
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35294
        • The Kirklin Clinic
    • California
      • Coronado, California, Stati Uniti, 92118
        • Southern California Research Center
      • Los Angeles, California, Stati Uniti, 90073
        • VA Greater Los Angeles Healthcare System
      • Los Angeles, California, Stati Uniti, 90036
        • Peter J Ruane Md Inc
      • San Diego, California, Stati Uniti, 92105
        • Research and Education, Inc.
      • San Diego, California, Stati Uniti, 92123
        • Medical Associates Research Group
      • San Diego, California, Stati Uniti, 92114
        • Precision Research Institute, LLC
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • University of Colorado Denver and Hospital
    • District of Columbia
      • Washington, D.C., District of Columbia, Stati Uniti, 20007
        • MedStar Georgetown University Hospital
    • Florida
      • Orlando, Florida, Stati Uniti, 32803
        • Orlando Immunology Center
      • South Miami, Florida, Stati Uniti, 33143
        • Miami Research Associates
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30308
        • Atlanta Gastroenterology Associates, LLC
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21202
        • Mercy Medical Center, Inc.
      • Lutherville, Maryland, Stati Uniti, 21093
        • Johns Hopkins University
    • New Jersey
      • Hillsborough, New Jersey, Stati Uniti, 08844
        • ID Care
    • New Mexico
      • Santa Fe, New Mexico, Stati Uniti, 87505
        • Southwest CARE Center
    • New York
      • The Bronx, New York, Stati Uniti, 10468
        • James J Peters VAMC
    • Oklahoma
      • Tulsa, Oklahoma, Stati Uniti, 74104
        • Options Health Research, LLC
      • Tulsa, Oklahoma, Stati Uniti, 74135
        • Healthcare Research Consultants
    • Texas
      • Arlington, Texas, Stati Uniti, 76012
        • Texas Clinical Research Institute
      • Houston, Texas, Stati Uniti, 77030
        • Research Specialists of Texas
      • San Antonio, Texas, Stati Uniti, 78215
        • Alamo Medical Research
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84106
        • Lifetree Clinical Research
    • Virginia
      • Fairfax, Virginia, Stati Uniti, 22031
        • Metropolitan Research
      • Falls Church, Virginia, Stati Uniti, 22042
        • Inova Fairfax Hospital
    • Wisconsin
      • Madison, Wisconsin, Stati Uniti, 53715
        • Dean Clinic

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Men and women, ages ≥18 years of age
  • Subjects who are naive to HCV treatment, defined as no previous exposure to an Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or experimental therapy or subjects who are null responders to previous pegylated Interferon alfa (pegIFNα) plus Ribavirin (RBV) treatment

  • Subjects should have chronic hepatitis C (CHC) as documented by:

    1. Positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to screening, and positive for HCV RNA and Anti-HCV antibody at the time of screening, or
    2. Positive for anti-HCV antibody and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrollment with evidence of CHC disease, such as the presence of fibrosis)
  • HCV genotype 1a, 1b or 4 only
  • HCV RNA viral load of ≥10,000 IU/mL at screening

  • Have one of the following:

    1. Documented Fibrotest score of ≤0.72 and aspartate transferase (transminase) to platelet ratio index (APRI) ≤2; OR
    2. Documented liver biopsy within 36 months preceding Day 1 showing absence of cirrhosis OR
    3. Documented Fibroscan® ultrasound (where approved) within 12 months of screening showing absence of cirrhosis
  • Body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive
  • Subjects with compensated Child-Pugh A cirrhosis as documented by history of cirrhosis with any prior liver biopsy or Fibroscan® ultrasound (where approved) within 12 months prior to screening

Exclusion Criteria:

  • Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis,metabolic liver disease, alcoholic liver disease, toxin exposures)
  • History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
  • 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
  • Documented or suspected hepatocellular carcinoma (HCC)
  • Positive for hepatitis B surface antigen (HBsAg)
  • Positive for Human Immunodeficiency Virus-1 (HIV-1) and/or Human Immunodeficiency Virus-2 (HIV-2) antibodies
  • Alanine transferase (transminase) (ALT) >5x upper limit of normal (ULN)
  • Total Bilirubin ≥2 mg/dL

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Group 1:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(75mg)

BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks

BMS-790052 60 mg tablet by mouth once daily for 24 Weeks

BMS 791325 75 mg table by mouth twice daily for 24 Weeks
Droga: BMS-791325
Droga: BMS-650032
Altri nomi:
  • Asunaprevir (ASV)
Droga: BMS-790052
Altri nomi:
  • Daclatasvir (DCV)
Sperimentale: Group 2:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(75mg)

BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks

BMS-790052 60 mg tablet by mouth once daily for 12 Weeks

BMS 791325 75 mg table by mouth twice daily for 12 Weeks
Droga: BMS-791325
Droga: BMS-650032
Altri nomi:
  • Asunaprevir (ASV)
Droga: BMS-790052
Altri nomi:
  • Daclatasvir (DCV)
Sperimentale: Group 3:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(150mg)

* Contingent upon review of safety data from all available treated subjects from Groups 1 and 2

BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks

BMS-790052 60 mg tablet by mouth once daily for 24 Weeks

BMS 791325 150 mg table by mouth twice daily for 24 Weeks
Droga: BMS-791325
Droga: BMS-650032
Altri nomi:
  • Asunaprevir (ASV)
Droga: BMS-790052
Altri nomi:
  • Daclatasvir (DCV)
Sperimentale: Group 4:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(150mg)

* Contingent upon review of safety data from all available treated subjects from Groups 1 and 2

BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks

BMS-790052 60 mg tablet by mouth once daily for 12 Weeks

BMS 791325 150 mg table by mouth twice daily for 12 Weeks
Droga: BMS-791325
Droga: BMS-650032
Altri nomi:
  • Asunaprevir (ASV)
Droga: BMS-790052
Altri nomi:
  • Daclatasvir (DCV)
Sperimentale: Group 5:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)

* Genotype 1 treatment-naive subjects

BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks

BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks

BMS 791325 75 mg table by mouth twice daily for 12 Weeks
Droga: BMS-791325
Droga: BMS-650032
Altri nomi:
  • Asunaprevir (ASV)
Droga: BMS-790052
Altri nomi:
  • Daclatasvir (DCV)
Sperimentale: Group 6:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)

* Genotype 1 treatment-naive subjects

BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks

BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks

BMS 791325 150 mg table by mouth twice daily for 12 Weeks
Droga: BMS-791325
Droga: BMS-650032
Altri nomi:
  • Asunaprevir (ASV)
Droga: BMS-790052
Altri nomi:
  • Daclatasvir (DCV)
Sperimentale: Group 7:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)

* Genotype 4 treatment-naive subjects

BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks

BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks

BMS 791325 75 mg table by mouth twice daily for 12 Weeks
Droga: BMS-791325
Droga: BMS-650032
Altri nomi:
  • Asunaprevir (ASV)
Droga: BMS-790052
Altri nomi:
  • Daclatasvir (DCV)
Sperimentale: Group 8:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)

* Genotype 4 treatment-naive subjects

BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks

BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks

BMS 791325 150 mg table by mouth twice daily for 12 Weeks
Droga: BMS-791325
Droga: BMS-650032
Altri nomi:
  • Asunaprevir (ASV)
Droga: BMS-790052
Altri nomi:
  • Daclatasvir (DCV)
Sperimentale: Group 9:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)

* Genotype 1 treatment-null/non-responder subjects

BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks

BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks

BMS 791325 75 mg table by mouth twice daily for 12 Weeks
Droga: BMS-791325
Droga: BMS-650032
Altri nomi:
  • Asunaprevir (ASV)
Droga: BMS-790052
Altri nomi:
  • Daclatasvir (DCV)
Sperimentale: Group10:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)

* Genotype 1 treatment-null/non-responder subjects

BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks

BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks

BMS 791325 150 mg table by mouth twice daily for 12 Weeks
Droga: BMS-791325
Droga: BMS-650032
Altri nomi:
  • Asunaprevir (ASV)
Droga: BMS-790052
Altri nomi:
  • Daclatasvir (DCV)
Sperimentale: Group11:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)

* Genotype 1 treatment-null/non-responder subjects

BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks

BMS-790052 30 mg tablet by mouth twice daily for 24 Weeks

BMS 791325 75 mg table by mouth twice daily for 24 Weeks
Droga: BMS-791325
Droga: BMS-650032
Altri nomi:
  • Asunaprevir (ASV)
Droga: BMS-790052
Altri nomi:
  • Daclatasvir (DCV)
Sperimentale: Group12:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)

* Genotype 1 treatment-null/non-responder subjects

BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks

BMS-790052 30 mg tablet by mouth twice daily for 24 Weeks

BMS 791325 150 mg table by mouth twice daily for 24 Weeks
Droga: BMS-791325
Droga: BMS-650032
Altri nomi:
  • Asunaprevir (ASV)
Droga: BMS-790052
Altri nomi:
  • Daclatasvir (DCV)
Sperimentale: Grp13:BMS-650032(200mg)+BMS-790052(30mg)+BMS-791325(75mg)+RBV

* Genotype 1 treatment-naive subjects

BMS-650032 200 mg tablets orally twice daily 12 weeks

BMS-790052 30 mg tablets orally twice daily 12 weeks

BMS-791325 75 mg tablets orally twice daily 12 weeks

Ribavirin (RBV) tablets orally weight based dosing daily 12 weeks [if subject is < 75 kg: 1000 mg per day orally (2 x 200 mg tablets in AM and 3 x 200 mg tablets in PM), or if ≥ 75 kg: 1200 mg per day orally (3 x 200 mg tablets in AM and 3 x 200 mg tablets in PM]
Droga: BMS-791325
Droga: Ribavirina
Altri nomi:
  • Copego®
Droga: BMS-650032
Altri nomi:
  • Asunaprevir (ASV)
Droga: BMS-790052
Altri nomi:
  • Daclatasvir (DCV)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Sustained virologic response (SVR) at 12 weeks post-treatment (SVR12)
Lasso di tempo: 12 weeks post-treatment
12 weeks post-treatment

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of subjects with HCV ribonucleic acid (RNA) < limit of quantification (LOQ) (detectable and undetectable)
Lasso di tempo: Weeks 1, 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22 and 24 weeks of therapy; at end of treatment (EOT) (following 12 or 24 weeks of treatment, by Group); and Weeks 4, 12, 24, 36, and 48 weeks post-treatment
Weeks 1, 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22 and 24 weeks of therapy; at end of treatment (EOT) (following 12 or 24 weeks of treatment, by Group); and Weeks 4, 12, 24, 36, and 48 weeks post-treatment
Proportion of subjects with HCV ribonucleic acid (RNA) undetectable
Lasso di tempo: Weeks 1, 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22 and 24 weeks of therapy; at end of treatment (EOT) (following 12 or 24 weeks of treatment, by Group); and Weeks 4, 12, 24, 36, and 48 weeks post-treatment
Weeks 1, 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22 and 24 weeks of therapy; at end of treatment (EOT) (following 12 or 24 weeks of treatment, by Group); and Weeks 4, 12, 24, 36, and 48 weeks post-treatment
Proportion of subjects who experience viral breakthrough
Lasso di tempo: Formal analysis at SVR12, Week 48 of follow up period (or upon occurrence)

viral breakthrough defined as:

  • Any increase in HCV RNA ≥ 1 log10 from nadir or
  • Any quantifiable HCV RNA ≥ 25 IU/mL (> LOQ) on or after Week 8
Formal analysis at SVR12, Week 48 of follow up period (or upon occurrence)
Proportion of subjects who experience viral relapse defined as confirmed quantifiable HCV RNA ≥ 25 IU/mL (>LOQ) in a subject with HCV RNA < LOQ or undetectable at End of treatment (EOT)
Lasso di tempo: End of treatment (Maximum up to 24 Weeks)
End of treatment (Maximum up to 24 Weeks)
Maximum observed plasma concentration (Cmax) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Lasso di tempo: Day 1 and Day 14
Day 1 and Day 14
Observed plasma concentration at 12 hours (C12) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Lasso di tempo: Day 1 and Day 14
Day 1 and Day 14
Observed plasma concentration at 24 hours (C24) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Lasso di tempo: Day 1 and Day 14
Day 1 and Day 14
Trough observed plasma concentration (Ctrough) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Lasso di tempo: Day 1 and Day 14
Day 1 and Day 14
Time of maximum observed plasma concentration (Tmax) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Lasso di tempo: Day 1 and Day 14
Day 1 and Day 14
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
Lasso di tempo: Day 1 and Day 14
Day 1 and Day 14
HCV genomic substitutions associated with exposure of BMS-650032, BMS-790052, and BMS-791325
Lasso di tempo: At the time of viral breakthrough or relapse
At the time of viral breakthrough or relapse
Frequency of deaths, serious adverse events (SAEs), discontinuations due to adverse events (AEs), severity Grade 3/4 AEs, and severity Grade 3/4 laboratory abnormalities
Lasso di tempo: Formal analysis at week 48 of follow up period (or upon occurrence)
Formal analysis at week 48 of follow up period (or upon occurrence)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bristol-Myers Squibb

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 novembre 2011

Completamento primario (Effettivo)

31 marzo 2014

Completamento dello studio (Effettivo)

31 luglio 2015

Date di iscrizione allo studio

Primo inviato

18 ottobre 2011

Primo inviato che soddisfa i criteri di controllo qualità

18 ottobre 2011

Primo Inserito (Stima)

19 ottobre 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 aprile 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 aprile 2017

Ultimo verificato

1 aprile 2017

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AI443-014
  • 2011-002788-11 (Numero EudraCT)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Epatite cronica C

Prove cliniche su BMS-791325

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Sponsor e collaboratori

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CROs by country

CROs in India

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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