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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. september 2015 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

512

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • 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
  • Danmark
      • Aarhus, Danmark, 8200
        • Local Institution
      • Hvidovre, Danmark, 2650
        • Local Institution
      • Odense, Danmark, 5000
        • Local Institution
  • Forente stater
    • Alabama
      • Montgomery, Alabama, Forente stater, 36116
        • Alabama Liver & Digestive Specialists (Alds)
    • California
      • La Jolla, California, Forente stater, 92037
        • Scripps Clinic
      • Los Angeles, California, Forente stater, 90048
        • CLI
      • San Diego, California, Forente stater, 92114
        • Desta Digestive Disease Medical Center
      • San Francisco, California, Forente stater, 94115
        • California Pacific Medical Center
      • San Francisco, California, Forente stater, 94110
        • University of California at San Francisco
      • San Francisco, California, Forente stater, 94118
        • Kaiser Permanente Medical Center
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • Transplant Center And Hepatology Clinic, B-154
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06520
        • Yale University School Of Medicine
    • Florida
      • Gainesville, Florida, Forente stater, 32610-0277
        • University Of Florida Hepatology
      • South Miami, Florida, Forente stater, 33143
        • Miami Research Associates
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202
        • Indiana University
    • Louisiana
      • New Orleans, Louisiana, Forente stater, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, Forente stater, 21202
        • Mercy Medical Center
      • Baltimore, Maryland, Forente stater, 21229
        • Digestive Disease Associates, P.A.
      • Lutherville, Maryland, Forente stater, 21093
        • Johns Hopkins Medical Institutions
    • Massachusetts
      • Springfield, Massachusetts, Forente stater, 01105
        • The Research Institute
    • Missouri
      • St. Louis, Missouri, Forente stater, 63104
        • Saint Louis University
    • New York
      • Albany, New York, Forente stater, 12208
        • Samuel S. Stratton Vamc
      • Bronx, New York, Forente stater, 10468
        • James J Peters VAMC
      • Great Neck, New York, Forente stater, 11201
        • James Sungsik Park, M.D. C.N.S.C.
      • Monticello, New York, Forente stater, 12701
        • Upper Delaware Valley Infectious Diseases, Pc
      • Rochester, New York, Forente stater, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Forente stater, 27599-7584
        • University of North Carolina, Chapel Hill
      • Statesville, North Carolina, Forente stater, 28677
        • Carolinas Center For Liver Disease
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74135
        • Healthcare Research Consultants
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02905
        • University Gastroenterology
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37205
        • Nashville Medical Research Institute
    • Texas
      • Arlington, Texas, Forente stater, 76012
        • North Texas Research Institute
      • Houston, Texas, Forente stater, 77030
        • Liver Associates of Texas
      • Houston, Texas, Forente stater, 77030
        • St. Luke'S Episcopal Hospital - Baylor College Of Medicine
      • San Antonio, Texas, Forente stater, 78215
        • Alamo Medical Research
    • Virginia
      • Fairfax, Virginia, Forente stater, 22031
        • Metropolitan Research
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53715
        • Dean Clinic
  • Frankrike
      • Clichy Cedex, Frankrike, 92118
        • Local Institution
      • Creteil Cedex, Frankrike, 94010
        • Local Institution
      • Lyon Cedex 04, Frankrike, 69317
        • Local Institution
      • Nice Cedex 03, Frankrike, 06202
        • Local Institution
      • Paris Cedex, Frankrike, 75013
        • Local Institution
      • Paris Cedex 14, Frankrike, 75679
        • Local Institution
      • Vandoeuvre Les Nancy, Frankrike, 54511
        • Local Institution
  • Italia
      • Cisanello (pisa), Italia, 56124
        • Local Institution
      • Pavia, Italia, 27100
        • Local Institution
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44160
        • Local Institution
    • Morelos
      • Cuernavaca, Morelos, Mexico, 62170
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64710
        • Local Institution
  • Puerto Rico
      • Ponce, Puerto Rico, 00780
        • Instituto De Investigacion Cientifica Del Sur
      • San Juan, Puerto Rico, 00927
        • Local Institution
  • Sverige
      • Gothenburg, Sverige, SE-416 85
        • Local Institution
      • Stockholm, Sverige, 14186
        • Local Institution
  • Tyskland
      • Essen, Tyskland, 45122
        • Local Institution
      • Frankfurt, Tyskland, 60590
        • Local Institution
      • Hamburg, Tyskland, 20099
        • Local Institution
      • Hannover, Tyskland, 30625
        • Local Institution

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm 1: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior null responders)
Legemiddel: BMS-790052
Film coated tablet, Oral, 20 mg, once daily, 24 weeks
Legemiddel: BMS-790052
Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
Legemiddel: peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
Andre navn:
  • Pegasys®
Legemiddel: ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Andre navn:
  • Copegus®
Eksperimentell: Arm 2: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior null responders)
Legemiddel: BMS-790052
Film coated tablet, Oral, 20 mg, once daily, 24 weeks
Legemiddel: BMS-790052
Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
Legemiddel: peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
Andre navn:
  • Pegasys®
Legemiddel: ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Andre navn:
  • Copegus®
Eksperimentell: Arm 3: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior partial responders)
Legemiddel: BMS-790052
Film coated tablet, Oral, 20 mg, once daily, 24 weeks
Legemiddel: BMS-790052
Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
Legemiddel: peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
Andre navn:
  • Pegasys®
Legemiddel: ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Andre navn:
  • Copegus®
Eksperimentell: Arm 4: BMS-790052 plus peginterferon alfa-2a and ribavirin
(prior partial responders)
Legemiddel: BMS-790052
Film coated tablet, Oral, 20 mg, once daily, 24 weeks
Legemiddel: BMS-790052
Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
Legemiddel: peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
Andre navn:
  • Pegasys®
Legemiddel: ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Andre navn:
  • Copegus®
Eksperimentell: Arm 5: Placebo plus peginterferon alfa-2a and ribavirin
(prior partial responders only)
Legemiddel: peginterferon alfa-2a
Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
Andre navn:
  • Pegasys®
Legemiddel: ribavirin
Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
Andre navn:
  • Copegus®
Legemiddel: Placebo
Film coated tablet, Oral, 0mg, Once daily, 24 weeks

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Rapid Virologic Response (RVR)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Bristol-Myers Squibb

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2010

Primær fullføring (Faktiske)

1. juni 2012

Studiet fullført (Faktiske)

1. desember 2012

Datoer for studieregistrering

Først innsendt

16. juli 2010

Først innsendt som oppfylte QC-kriteriene

26. juli 2010

Først lagt ut (Anslag)

28. juli 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

12. oktober 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. september 2015

Sist bekreftet

1. september 2015

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AI444-011
  • 2010-019378-34 (EudraCT-nummer)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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