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Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment (HEPCAT)

11 settembre 2015 aggiornato da: Bristol-Myers Squibb

A Phase 2B Study of BMS-790052 in Combination With Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who Are Null or Partial Responders to Prior Treatment With Peginterferon Alfa Plus Ribavirin Therapy

The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

512

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

  • Argentina
    • Buenos Aires
      • Ciudad De Buenos Aires, Buenos Aires, Argentina, C1121ABE
        • Local Institution
      • Ciudad De Buenos Aires, Buenos Aires, Argentina, C1181ACH
        • Local Institution
    • Santa Fe
      • Prov De Santa Fe, Santa Fe, Argentina, 2000
        • Local Institution
  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Local Institution
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Local Institution
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution
      • Prahan, Victoria, Australia, 3004
        • Local Institution
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Local Institution
      • Perth, Western Australia, Australia, 6001
        • Local Institution
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Local Institution
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • Local Institution
      • Victoria, British Columbia, Canada, V8V 3P9
        • Local Institution
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
        • Local Institution
      • Toronto, Ontario, Canada, M5T 2S8
        • Local Institution
  • Danimarca
      • Aarhus, Danimarca, 8200
        • Local Institution
      • Hvidovre, Danimarca, 2650
        • Local Institution
      • Odense, Danimarca, 5000
        • Local Institution
  • Francia
      • Clichy Cedex, Francia, 92118
        • Local Institution
      • Creteil Cedex, Francia, 94010
        • Local Institution
      • Lyon Cedex 04, Francia, 69317
        • Local Institution
      • Nice Cedex 03, Francia, 06202
        • Local Institution
      • Paris Cedex, Francia, 75013
        • Local Institution
      • Paris Cedex 14, Francia, 75679
        • Local Institution
      • Vandoeuvre Les Nancy, Francia, 54511
        • Local Institution
  • Germania
      • Essen, Germania, 45122
        • Local Institution
      • Frankfurt, Germania, 60590
        • Local Institution
      • Hamburg, Germania, 20099
        • Local Institution
      • Hannover, Germania, 30625
        • Local Institution
  • Italia
      • Cisanello (pisa), Italia, 56124
        • Local Institution
      • Pavia, Italia, 27100
        • Local Institution
  • Messico
    • Jalisco
      • Guadalajara, Jalisco, Messico, 44160
        • Local Institution
    • Morelos
      • Cuernavaca, Morelos, Messico, 62170
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Messico, 64710
        • Local Institution
  • Porto Rico
      • Ponce, Porto Rico, 00780
        • Instituto De Investigacion Cientifica Del Sur
      • San Juan, Porto Rico, 00927
        • Local Institution
  • Stati Uniti
    • Alabama
      • Montgomery, Alabama, Stati Uniti, 36116
        • Alabama Liver & Digestive Specialists (Alds)
    • California
      • La Jolla, California, Stati Uniti, 92037
        • Scripps Clinic
      • Los Angeles, California, Stati Uniti, 90048
        • CLI
      • San Diego, California, Stati Uniti, 92114
        • Desta Digestive Disease Medical Center
      • San Francisco, California, Stati Uniti, 94115
        • California Pacific Medical Center
      • San Francisco, California, Stati Uniti, 94110
        • University of California at San Francisco
      • San Francisco, California, Stati Uniti, 94118
        • Kaiser Permanente Medical Center
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • Transplant Center And Hepatology Clinic, B-154
    • Connecticut
      • New Haven, Connecticut, Stati Uniti, 06520
        • Yale University School of Medicine
    • Florida
      • Gainesville, Florida, Stati Uniti, 32610-0277
        • University Of Florida Hepatology
      • South Miami, Florida, Stati Uniti, 33143
        • Miami Research Associates
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Indiana University
    • Louisiana
      • New Orleans, Louisiana, Stati Uniti, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21202
        • Mercy Medical Center
      • Baltimore, Maryland, Stati Uniti, 21229
        • Digestive Disease Associates, P.A.
      • Lutherville, Maryland, Stati Uniti, 21093
        • Johns Hopkins Medical Institutions
    • Massachusetts
      • Springfield, Massachusetts, Stati Uniti, 01105
        • The Research Institute
    • Missouri
      • St. Louis, Missouri, Stati Uniti, 63104
        • Saint Louis University
    • New York
      • Albany, New York, Stati Uniti, 12208
        • Samuel S. Stratton Vamc
      • Bronx, New York, Stati Uniti, 10468
        • James J Peters VAMC
      • Great Neck, New York, Stati Uniti, 11201
        • James Sungsik Park, M.D. C.N.S.C.
      • Monticello, New York, Stati Uniti, 12701
        • Upper Delaware Valley Infectious Diseases, Pc
      • Rochester, New York, Stati Uniti, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27599-7584
        • University of North Carolina, Chapel Hill
      • Statesville, North Carolina, Stati Uniti, 28677
        • Carolinas Center For Liver Disease
    • Oklahoma
      • Tulsa, Oklahoma, Stati Uniti, 74135
        • Healthcare Research Consultants
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02905
        • University Gastroenterology
    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37205
        • Nashville Medical Research Institute
    • Texas
      • Arlington, Texas, Stati Uniti, 76012
        • North Texas Research Institute
      • Houston, Texas, Stati Uniti, 77030
        • Liver Associates of Texas
      • Houston, Texas, Stati Uniti, 77030
        • St. Luke'S Episcopal Hospital - Baylor College Of Medicine
      • San Antonio, Texas, Stati Uniti, 78215
        • Alamo Medical Research
    • Virginia
      • Fairfax, Virginia, Stati Uniti, 22031
        • Metropolitan Research
    • Wisconsin
      • Madison, Wisconsin, Stati Uniti, 53715
        • Dean Clinic
  • Svezia
      • Gothenburg, Svezia, SE-416 85
        • Local Institution
      • Stockholm, Svezia, 14186
        • Local Institution

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

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Subjects chronically infected with HCV genotype 1
  • Non-responder to prior therapy with peginterferon alfa and ribavirin
  • HCV RNA viral load of 100,00 IU/mL
  • Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic HCV infection; for compensated cirrhotics can be any time prior to randomization (compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study population)
  • Ultrasound, CT scan or MRI results 12 months prior to randomization that do not demonstrate hepatocellular carcinoma
  • Body Mass Index (BMI) of 18 to 35 kg/m2

Exclusion Criteria:

  • Positive for Hepatitis B infection (HBsAg) or HIV-1/HIV-2 antibody at screening
  • Evidence of medical condition associated with chronic liver disease other than HCV
  • Evidence of decompensated cirrhosis based on radiologic criteria or biopsy

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: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior null responders)
Droga: BMS-790052
Film coated tablet, Oral, 20 mg, once daily, 24 weeks
Droga: BMS-790052
Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
Droga: peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
Altri nomi:
  • Pegasys®
Droga: ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Altri nomi:
  • Copego®
Sperimentale: Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior null responders)
Droga: BMS-790052
Film coated tablet, Oral, 20 mg, once daily, 24 weeks
Droga: BMS-790052
Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
Droga: peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
Altri nomi:
  • Pegasys®
Droga: ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Altri nomi:
  • Copego®
Sperimentale: Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior partial responders)
Droga: BMS-790052
Film coated tablet, Oral, 20 mg, once daily, 24 weeks
Droga: BMS-790052
Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
Droga: peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
Altri nomi:
  • Pegasys®
Droga: ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Altri nomi:
  • Copego®
Sperimentale: Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior partial responders)
Droga: BMS-790052
Film coated tablet, Oral, 20 mg, once daily, 24 weeks
Droga: BMS-790052
Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
Droga: peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
Altri nomi:
  • Pegasys®
Droga: ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Altri nomi:
  • Copego®
Sperimentale: Arm 5: Placebo plus peginterferon alfa-2a and ribavirin
(prior partial responders only)
Droga: peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
Altri nomi:
  • Pegasys®
Droga: ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Altri nomi:
  • Copego®
Droga: Placebo
Film coated tablet, Oral, 0mg, Once daily, 24 weeks

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Lasso di tempo: Week 4, Week 12
eRVR was defined as undetectable Hepatitis C virus RNA at both Weeks 4 and 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Week 4, Week 12
Percentage of Participants With 24-week Sustained Virologic Response (SVR24)
Lasso di tempo: Follow-up Week 24
SVR24 was defined as undetectable RNA (Hepatitis C Virus [HCV] RNA <lower limit of quantitation [LLOQ], target not detected [TND]) at follow-up Week 24. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Follow-up Week 24
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs) and Who Died On-treatment
Lasso di tempo: From first dose to last dose plus 7 days, up to 49 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. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity; or was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
From first dose to last dose plus 7 days, up to 49 weeks
Number of Participants With Serious Adverse Events (SAEs) and Who Died During Follow-up Period
Lasso di tempo: From day 8 post last dose of treatment up-to Week 72
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. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
From day 8 post last dose of treatment up-to Week 72

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With Rapid Virologic Response (RVR)
Lasso di tempo: Week 4
RVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation [LLOQ], target not detected (TND) at Week 4. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
Week 4
Percentage of Participants With Complete Early Virologic Response (cEVR)
Lasso di tempo: Week 12
cEVR was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation [LLOQ], target not detected (TND) at Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
Week 12
Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12)
Lasso di tempo: Follow-up Week 12
SVR12 was defined as undetectable RNA ie., Hepatitis C virus (HCV) RNA <lower limit of quantitation (LLOQ), target not detected (TND) at follow-up Week 12. TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Follow-up Week 12
Number of Participants With Genotypic-1A Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Lasso di tempo: Baseline to follow-up Week 48
Non-structural protein 5A of HCV resistance associated polymorphism in GT-1a samples included M28L/T/V, Q30H, L31M, H54Y, H58C/D/N/P/Q, E62D and Y93C.
Baseline to follow-up Week 48
Number of Participants With Genotypic-1B Substitution at Baseline, On-treatment and During Follow-up Associated With Virologic Failures
Lasso di tempo: Baseline to follow-up Week 48
Non-structural protein 5A of HCV resistance associated polymorphisms in GT-1b samples, included L28M/V, R30H/Q, L31M, Q54H/N/Y, P58A/Q/S, Q62E/K/N/R/S, A92T/V and Y93F/H.
Baseline to follow-up Week 48

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.

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

1 agosto 2010

Completamento primario (Effettivo)

1 giugno 2012

Completamento dello studio (Effettivo)

1 dicembre 2012

Date di iscrizione allo studio

Primo inviato

16 luglio 2010

Primo inviato che soddisfa i criteri di controllo qualità

26 luglio 2010

Primo Inserito (Stima)

28 luglio 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

12 ottobre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 settembre 2015

Ultimo verificato

1 settembre 2015

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • AI444-011
  • 2010-019378-34 (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 Virus dell'epatite C

Prove cliniche su BMS-790052

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Sponsor e collaboratori

Condizioni mediche

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CROs by country

CROs in Ghana

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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