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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

512

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

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
  • Australien
    • New South Wales
      • Randwick, New South Wales, Australien, 2031
        • Local Institution
    • Victoria
      • Clayton, Victoria, Australien, 3168
        • Local Institution
      • Heidelberg, Victoria, Australien, 3084
        • Local Institution
      • Prahan, Victoria, Australien, 3004
        • Local Institution
    • Western Australia
      • Fremantle, Western Australia, Australien, 6160
        • Local Institution
      • Perth, Western Australia, Australien, 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
  • Forenede Stater
    • Alabama
      • Montgomery, Alabama, Forenede Stater, 36116
        • Alabama Liver & Digestive Specialists (Alds)
    • California
      • La Jolla, California, Forenede Stater, 92037
        • Scripps Clinic
      • Los Angeles, California, Forenede Stater, 90048
        • CLI
      • San Diego, California, Forenede Stater, 92114
        • Desta Digestive Disease Medical Center
      • San Francisco, California, Forenede Stater, 94115
        • California Pacific Medical Center
      • San Francisco, California, Forenede Stater, 94110
        • University of California at San Francisco
      • San Francisco, California, Forenede Stater, 94118
        • Kaiser Permanente Medical Center
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Transplant Center And Hepatology Clinic, B-154
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520
        • Yale University School of Medicine
    • Florida
      • Gainesville, Florida, Forenede Stater, 32610-0277
        • University Of Florida Hepatology
      • South Miami, Florida, Forenede Stater, 33143
        • Miami Research Associates
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana University
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21202
        • Mercy Medical Center
      • Baltimore, Maryland, Forenede Stater, 21229
        • Digestive Disease Associates, P.A.
      • Lutherville, Maryland, Forenede Stater, 21093
        • Johns Hopkins Medical Institutions
    • Massachusetts
      • Springfield, Massachusetts, Forenede Stater, 01105
        • The Research Institute
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63104
        • Saint Louis University
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Samuel S. Stratton Vamc
      • Bronx, New York, Forenede Stater, 10468
        • James J Peters VAMC
      • Great Neck, New York, Forenede Stater, 11201
        • James Sungsik Park, M.D. C.N.S.C.
      • Monticello, New York, Forenede Stater, 12701
        • Upper Delaware Valley Infectious Diseases, Pc
      • Rochester, New York, Forenede Stater, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599-7584
        • University of North Carolina, Chapel Hill
      • Statesville, North Carolina, Forenede Stater, 28677
        • Carolinas Center For Liver Disease
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74135
        • Healthcare Research Consultants
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02905
        • University Gastroenterology
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37205
        • Nashville Medical Research Institute
    • Texas
      • Arlington, Texas, Forenede Stater, 76012
        • North Texas Research Institute
      • Houston, Texas, Forenede Stater, 77030
        • Liver Associates of Texas
      • Houston, Texas, Forenede Stater, 77030
        • St. Luke'S Episcopal Hospital - Baylor College Of Medicine
      • San Antonio, Texas, Forenede Stater, 78215
        • Alamo Medical Research
    • Virginia
      • Fairfax, Virginia, Forenede Stater, 22031
        • Metropolitan Research
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53715
        • Dean Clinic
  • Frankrig
      • Clichy Cedex, Frankrig, 92118
        • Local Institution
      • Creteil Cedex, Frankrig, 94010
        • Local Institution
      • Lyon Cedex 04, Frankrig, 69317
        • Local Institution
      • Nice Cedex 03, Frankrig, 06202
        • Local Institution
      • Paris Cedex, Frankrig, 75013
        • Local Institution
      • Paris Cedex 14, Frankrig, 75679
        • Local Institution
      • Vandoeuvre Les Nancy, Frankrig, 54511
        • Local Institution
  • Italien
      • Cisanello (pisa), Italien, 56124
        • Local Institution
      • Pavia, Italien, 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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bristol-Myers Squibb

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. august 2010

Primær færdiggørelse (Faktiske)

1. juni 2012

Studieafslutning (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

16. juli 2010

Først indsendt, der opfyldte QC-kriterier

26. juli 2010

Først opslået (Skøn)

28. juli 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. oktober 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. september 2015

Sidst verificeret

1. september 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Hepatitis C virus

Kliniske forsøg med BMS-790052

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Betingelser

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