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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 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

512

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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
  • Danmark
      • Aarhus, Danmark, 8200
        • Local Institution
      • Hvidovre, Danmark, 2650
        • Local Institution
      • Odense, Danmark, 5000
        • Local Institution
  • 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
  • Förenta staterna
    • Alabama
      • Montgomery, Alabama, Förenta staterna, 36116
        • Alabama Liver & Digestive Specialists (Alds)
    • California
      • La Jolla, California, Förenta staterna, 92037
        • Scripps Clinic
      • Los Angeles, California, Förenta staterna, 90048
        • CLI
      • San Diego, California, Förenta staterna, 92114
        • Desta Digestive Disease Medical Center
      • San Francisco, California, Förenta staterna, 94115
        • California Pacific Medical Center
      • San Francisco, California, Förenta staterna, 94110
        • University of California at San Francisco
      • San Francisco, California, Förenta staterna, 94118
        • Kaiser Permanente Medical Center
    • Colorado
      • Aurora, Colorado, Förenta staterna, 80045
        • Transplant Center And Hepatology Clinic, B-154
    • Connecticut
      • New Haven, Connecticut, Förenta staterna, 06520
        • Yale University School of Medicine
    • Florida
      • Gainesville, Florida, Förenta staterna, 32610-0277
        • University Of Florida Hepatology
      • South Miami, Florida, Förenta staterna, 33143
        • Miami Research Associates
    • Indiana
      • Indianapolis, Indiana, Förenta staterna, 46202
        • Indiana University
    • Louisiana
      • New Orleans, Louisiana, Förenta staterna, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21202
        • Mercy Medical Center
      • Baltimore, Maryland, Förenta staterna, 21229
        • Digestive Disease Associates, P.A.
      • Lutherville, Maryland, Förenta staterna, 21093
        • Johns Hopkins Medical Institutions
    • Massachusetts
      • Springfield, Massachusetts, Förenta staterna, 01105
        • The Research Institute
    • Missouri
      • St. Louis, Missouri, Förenta staterna, 63104
        • Saint Louis University
    • New York
      • Albany, New York, Förenta staterna, 12208
        • Samuel S. Stratton Vamc
      • Bronx, New York, Förenta staterna, 10468
        • James J Peters VAMC
      • Great Neck, New York, Förenta staterna, 11201
        • James Sungsik Park, M.D. C.N.S.C.
      • Monticello, New York, Förenta staterna, 12701
        • Upper Delaware Valley Infectious Diseases, Pc
      • Rochester, New York, Förenta staterna, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, Förenta staterna, 27599-7584
        • University of North Carolina, Chapel Hill
      • Statesville, North Carolina, Förenta staterna, 28677
        • Carolinas Center For Liver Disease
    • Oklahoma
      • Tulsa, Oklahoma, Förenta staterna, 74135
        • Healthcare Research Consultants
    • Pennsylvania
      • Philadelphia, Pennsylvania, Förenta staterna, 19104
        • University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, Förenta staterna, 02905
        • University Gastroenterology
    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37205
        • Nashville Medical Research Institute
    • Texas
      • Arlington, Texas, Förenta staterna, 76012
        • North Texas Research Institute
      • Houston, Texas, Förenta staterna, 77030
        • Liver Associates of Texas
      • Houston, Texas, Förenta staterna, 77030
        • St. Luke'S Episcopal Hospital - Baylor College Of Medicine
      • San Antonio, Texas, Förenta staterna, 78215
        • Alamo Medical Research
    • Virginia
      • Fairfax, Virginia, Förenta staterna, 22031
        • Metropolitan Research
    • Wisconsin
      • Madison, Wisconsin, Förenta staterna, 53715
        • Dean Clinic
  • Italien
      • Cisanello (pisa), Italien, 56124
        • Local Institution
      • Pavia, Italien, 27100
        • Local Institution
  • Kanada
    • Alberta
      • Edmonton, Alberta, Kanada, T6G 2B7
        • Local Institution
    • British Columbia
      • Vancouver, British Columbia, Kanada, V6Z 2K5
        • Local Institution
      • Victoria, British Columbia, Kanada, V8V 3P9
        • Local Institution
    • Ontario
      • Toronto, Ontario, Kanada, M5G 2N2
        • Local Institution
      • Toronto, Ontario, Kanada, M5T 2S8
        • Local Institution
  • Mexiko
    • Jalisco
      • Guadalajara, Jalisco, Mexiko, 44160
        • Local Institution
    • Morelos
      • Cuernavaca, Morelos, Mexiko, 62170
        • Local Institution
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexiko, 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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants With Rapid Virologic Response (RVR)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Bristol-Myers Squibb

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 augusti 2010

Primärt slutförande (Faktisk)

1 juni 2012

Avslutad studie (Faktisk)

1 december 2012

Studieregistreringsdatum

Först inskickad

16 juli 2010

Först inskickad som uppfyllde QC-kriterierna

26 juli 2010

Första postat (Uppskatta)

28 juli 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

12 oktober 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 september 2015

Senast verifierad

1 september 2015

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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