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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 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

350

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

  • 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

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: Treatment A: PSI-7977 + Daclatasvir
Genotype 1a or 1b
Medicin: PSI-7977
Tablets, oral, 400 mg, once daily
Medicin: Daclatasvir
Tablets, oral, 60 mg, once daily
Andre navne:
  • BMS-790052
Eksperimentel: Treatment B: PSI-7977 + Daclatasvir
Genotype 2 or 3
Medicin: PSI-7977
Tablets, oral, 400 mg, once daily
Medicin: Daclatasvir
Tablets, oral, 60 mg, once daily
Andre navne:
  • BMS-790052
Eksperimentel: Treatment C: PSI-7977 + Daclatasvir
Genotype 1a or 1b
Medicin: PSI-7977
Tablets, oral, 400 mg, once daily
Medicin: Daclatasvir
Tablets, oral, 60 mg, once daily
Andre navne:
  • BMS-790052
Eksperimentel: Treatment D: PSI-7977 + Daclatasvir
Genotype 2 or 3
Medicin: PSI-7977
Tablets, oral, 400 mg, once daily
Medicin: Daclatasvir
Tablets, oral, 60 mg, once daily
Andre navne:
  • BMS-790052
Eksperimentel: Treatment E: PSI-7977 + Daclatasvir + Ribavirin
Genotype 1a or 1b
Medicin: PSI-7977
Tablets, oral, 400 mg, once daily
Medicin: Daclatasvir
Tablets, oral, 60 mg, once daily
Andre navne:
  • BMS-790052
Medicin: Ribavirin
Tablets, oral, 200 mg
Andre navne:
  • Copegus ®
Eksperimentel: Treatment F: PSI-7977 + Daclatasvir+ Ribavirin
Genotype 2 or 3
Medicin: PSI-7977
Tablets, oral, 400 mg, once daily
Medicin: Daclatasvir
Tablets, oral, 60 mg, once daily
Andre navne:
  • BMS-790052
Medicin: Ribavirin
Tablets, oral, 200 mg
Andre navne:
  • Copegus ®
Eksperimentel: Treatment G: PSI-7977 + Daclatasvir

Hepatitis C virus genotype 1, treatment-naive patients

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

Hepatitis C virus genotype 1, treatment-naive patients

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

Patients who experienced telaprevir/boceprevir treatment failure

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

Patients who experienced telaprevir/boceprevir treatment failure

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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)

Samarbejdspartnere og efterforskere

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

Sponsor

Bristol-Myers Squibb

Samarbejdspartnere

Pharmasset

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

1. juni 2011

Primær færdiggørelse (Faktiske)

1. januar 2013

Studieafslutning (Faktiske)

1. oktober 2013

Datoer for studieregistrering

Først indsendt

23. maj 2011

Først indsendt, der opfyldte QC-kriterier

24. maj 2011

Først opslået (Skøn)

25. maj 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. oktober 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. september 2015

Sidst verificeret

1. september 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AI444-040

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 Kronisk hepatitis C

Kliniske forsøg med PSI-7977

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Sponsorer og samarbejdspartnere

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CROs by country

CROs in Türkiye

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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