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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. april 2017 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

IND numbers: 79,599; 101,943

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

320

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

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

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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
Medicin: BMS-791325
Medicin: BMS-650032
Andre navne:
  • Asunaprevir (ASV)
Medicin: BMS-790052
Andre navne:
  • Daclatasvir (DCV)
Eksperimentel: 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
Medicin: BMS-791325
Medicin: BMS-650032
Andre navne:
  • Asunaprevir (ASV)
Medicin: BMS-790052
Andre navne:
  • Daclatasvir (DCV)
Eksperimentel: 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
Medicin: BMS-791325
Medicin: BMS-650032
Andre navne:
  • Asunaprevir (ASV)
Medicin: BMS-790052
Andre navne:
  • Daclatasvir (DCV)
Eksperimentel: 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
Medicin: BMS-791325
Medicin: BMS-650032
Andre navne:
  • Asunaprevir (ASV)
Medicin: BMS-790052
Andre navne:
  • Daclatasvir (DCV)
Eksperimentel: 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
Medicin: BMS-791325
Medicin: BMS-650032
Andre navne:
  • Asunaprevir (ASV)
Medicin: BMS-790052
Andre navne:
  • Daclatasvir (DCV)
Eksperimentel: 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
Medicin: BMS-791325
Medicin: BMS-650032
Andre navne:
  • Asunaprevir (ASV)
Medicin: BMS-790052
Andre navne:
  • Daclatasvir (DCV)
Eksperimentel: 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
Medicin: BMS-791325
Medicin: BMS-650032
Andre navne:
  • Asunaprevir (ASV)
Medicin: BMS-790052
Andre navne:
  • Daclatasvir (DCV)
Eksperimentel: 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
Medicin: BMS-791325
Medicin: BMS-650032
Andre navne:
  • Asunaprevir (ASV)
Medicin: BMS-790052
Andre navne:
  • Daclatasvir (DCV)
Eksperimentel: 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
Medicin: BMS-791325
Medicin: BMS-650032
Andre navne:
  • Asunaprevir (ASV)
Medicin: BMS-790052
Andre navne:
  • Daclatasvir (DCV)
Eksperimentel: 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
Medicin: BMS-791325
Medicin: BMS-650032
Andre navne:
  • Asunaprevir (ASV)
Medicin: BMS-790052
Andre navne:
  • Daclatasvir (DCV)
Eksperimentel: 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
Medicin: BMS-791325
Medicin: BMS-650032
Andre navne:
  • Asunaprevir (ASV)
Medicin: BMS-790052
Andre navne:
  • Daclatasvir (DCV)
Eksperimentel: 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
Medicin: BMS-791325
Medicin: BMS-650032
Andre navne:
  • Asunaprevir (ASV)
Medicin: BMS-790052
Andre navne:
  • Daclatasvir (DCV)
Eksperimentel: 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]
Medicin: BMS-791325
Medicin: Ribavirin
Andre navne:
  • Copegus®
Medicin: BMS-650032
Andre navne:
  • Asunaprevir (ASV)
Medicin: BMS-790052
Andre navne:
  • Daclatasvir (DCV)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Sustained virologic response (SVR) at 12 weeks post-treatment (SVR12)
Tidsramme: 12 weeks post-treatment
12 weeks post-treatment

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of subjects with HCV ribonucleic acid (RNA) < limit of quantification (LOQ) (detectable and undetectable)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Day 1 and Day 14
Day 1 and Day 14
HCV genomic substitutions associated with exposure of BMS-650032, BMS-790052, and BMS-791325
Tidsramme: 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
Tidsramme: Formal analysis at week 48 of follow up period (or upon occurrence)
Formal analysis at week 48 of follow up period (or upon occurrence)

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.

Generelle publikationer

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 (Faktiske)

30. november 2011

Primær færdiggørelse (Faktiske)

31. marts 2014

Studieafslutning (Faktiske)

31. juli 2015

Datoer for studieregistrering

Først indsendt

18. oktober 2011

Først indsendt, der opfyldte QC-kriterier

18. oktober 2011

Først opslået (Skøn)

19. oktober 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AI443-014
  • 2011-002788-11 (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 .

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