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Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care

23. september 2015 oppdatert av: Bristol-Myers Squibb

Parallel, Open-Label, Randomized Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of PSI-7977 in Combination With BMS-790052 With or Without Ribavirin in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotypes 1, 2, or 3

The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

350

Fase

  • Fase 2

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • California
      • Coronado, California, Forente stater, 92118
        • Southern California Liver Centers
      • San Diego, California, Forente stater, 92105
        • Research and Education, Inc.
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • University Of Colorado Denver & Hospital
    • Florida
      • Gainesville, Florida, Forente stater, 32610
        • University Of Florida Hepatology
      • Orlando, Florida, Forente stater, 32803
        • Orlando Immunology Center
      • South Miami, Florida, Forente stater, 33143
        • Miami Research Associates
    • Maryland
      • Baltimore, Maryland, Forente stater, 21202
        • Mercy Medical Center
      • Lutherville, Maryland, Forente stater, 21093
        • Johns Hopkins University
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan Health System
    • New York
      • Bronx, New York, Forente stater, 10468
        • Bronx Va Medical Center 3c Sub-J
      • New York, New York, Forente stater, 10021
        • Weill Cornell Medical College
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74104
        • Options Health Research, LLC
      • Tulsa, Oklahoma, Forente stater, 74135
        • Healthcare Research Consultants
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • University of Pennsylvania
    • Texas
      • San Antonio, Texas, Forente stater, 78215
        • Alamo Medical Research
    • Virginia
      • Annandale, Virginia, Forente stater, 22003
        • Metropolitan Research
    • Wisconsin
      • Madison, Wisconsin, Forente stater, 53715
        • Dean Clinic
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • 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:

  • Men and women, ages 18 to 70 years.
  • Participants infected with hepatitis C virus (HCV) genotype 1, 2, or 3, with no previous exposure to an interferon formulation (ie, interferon-alpha, pegylated interferon-alpha) ribavirin, or other HCV-specific direct-acting antiviral (including daclatasvir and PSI-7977).
  • Patients should have chronic hepatitis C genotype 1a, 1b, 2, or 3 as documented by: positive test results for anti-HCV antibody; HCV RNA; or a HCV genotype at least 6 months prior to screening, and HCV RNA and anti-HCV antibody at the time of screening.

Exclusion Criteria:

  • Evidence of a medical condition associate with chronic liver disease other than HCV.
  • History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis.
  • History of hemophilia.
  • History of torsade de pointes.
  • 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.
  • History of gastrointestinal disease or surgical procedure (except cholecystectomy).
  • History of clinically significant cardiac disease.
  • Blood transfusion within 4 weeks prior to study drug administration.
  • Poor venous access.
  • Any other medical, psychiatric, and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study.

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: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Treatment A: PSI-7977 + Daclatasvir
Genotype 1a or 1b
Legemiddel: PSI-7977
Tablets, oral, 400 mg, once daily
Legemiddel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andre navn:
  • BMS-790052
Eksperimentell: Treatment B: PSI-7977 + Daclatasvir
Genotype 2 or 3
Legemiddel: PSI-7977
Tablets, oral, 400 mg, once daily
Legemiddel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andre navn:
  • BMS-790052
Eksperimentell: Treatment C: PSI-7977 + Daclatasvir
Genotype 1a or 1b
Legemiddel: PSI-7977
Tablets, oral, 400 mg, once daily
Legemiddel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andre navn:
  • BMS-790052
Eksperimentell: Treatment D: PSI-7977 + Daclatasvir
Genotype 2 or 3
Legemiddel: PSI-7977
Tablets, oral, 400 mg, once daily
Legemiddel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andre navn:
  • BMS-790052
Eksperimentell: Treatment E: PSI-7977 + Daclatasvir + Ribavirin
Genotype 1a or 1b
Legemiddel: PSI-7977
Tablets, oral, 400 mg, once daily
Legemiddel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andre navn:
  • BMS-790052
Legemiddel: Ribavirin
Tablets, oral, 200 mg
Andre navn:
  • Copegus ®
Eksperimentell: Treatment F: PSI-7977 + Daclatasvir+ Ribavirin
Genotype 2 or 3
Legemiddel: PSI-7977
Tablets, oral, 400 mg, once daily
Legemiddel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andre navn:
  • BMS-790052
Legemiddel: Ribavirin
Tablets, oral, 200 mg
Andre navn:
  • Copegus ®
Eksperimentell: Treatment G: PSI-7977 + Daclatasvir

Hepatitis C virus genotype 1, treatment-naive patients

Genotype 1a or 1b
Legemiddel: PSI-7977
Tablets, oral, 400 mg, once daily
Legemiddel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andre navn:
  • BMS-790052
Eksperimentell: Treatment H: PSI-7977 + BMS-790052 + Ribavirin

Hepatitis C virus genotype 1, treatment-naive patients

Genotype 1a or 1b
Legemiddel: PSI-7977
Tablets, oral, 400 mg, once daily
Legemiddel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andre navn:
  • BMS-790052
Legemiddel: Ribavirin
Tablets, oral, 200 mg
Andre navn:
  • Copegus ®
Eksperimentell: Treatment I: PSI-7977 + Daclatasvir

Patients who experienced telaprevir/boceprevir treatment failure

Genotype 1a or 1b
Legemiddel: PSI-7977
Tablets, oral, 400 mg, once daily
Legemiddel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andre navn:
  • BMS-790052
Eksperimentell: Treatment J: PSI-7977 + Daclatasvir + Ribavirin

Patients who experienced telaprevir/boceprevir treatment failure

Genotype 1a or 1b
Legemiddel: PSI-7977
Tablets, oral, 400 mg, once daily
Legemiddel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andre navn:
  • BMS-790052
Legemiddel: Ribavirin
Tablets, oral, 200 mg
Andre navn:
  • Copegus ®

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
Tidsramme: Follow-up Week 12
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA <25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir.
Follow-up Week 12

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
Tidsramme: Follow-up Week 24
SVR24 was defined as participant's hepatitis C virus RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 24. DCV=daclatasvir, SOF=sofosbuvir.
Follow-up Week 24
Percentage of Participants With Viral Breakthrough During the Treatment Period
Tidsramme: First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)
Viral breakthrough is defined as any confirmed increase in viral load ≥1 log from nadir or any confirmed hepatitis C virus RNA levels ≥25 IU/mL on or after Week 8.
First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)
Percentage of Participants Who Experienced Viral Relapse During Follow-up Period
Tidsramme: Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)
Viral relapse during follow-up is defined as any confirmed quantifiable hepatitis C virus (HCV) RNA ≥25 IU/mL with HCV RNA levels less than the lower limit of quantitation, target detected or target not detected, ie, HCV RNA <25 IU/mL at the end of treatment.
Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)
Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24
Tidsramme: Baseline, Follow-up week 24
Change from baseline in log10 HCV RNA at scheduled sampling time.
Baseline, Follow-up week 24
Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy
Tidsramme: First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)
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 with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe.
First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)
Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period
Tidsramme: AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 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 with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe
AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks)

Samarbeidspartnere og etterforskere

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

Sponsor

Bristol-Myers Squibb

Samarbeidspartnere

Pharmasset

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.

Generelle publikasjoner

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. juni 2011

Primær fullføring (Faktiske)

1. januar 2013

Studiet fullført (Faktiske)

1. oktober 2013

Datoer for studieregistrering

Først innsendt

23. mai 2011

Først innsendt som oppfylte QC-kriteriene

24. mai 2011

Først lagt ut (Anslag)

25. mai 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

23. oktober 2015

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. september 2015

Sist bekreftet

1. september 2015

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AI444-040

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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