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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 bijgewerkt door: 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

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

350

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Treatment A: PSI-7977 + Daclatasvir
Genotype 1a or 1b
Geneesmiddel: PSI-7977
Tablets, oral, 400 mg, once daily
Geneesmiddel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andere namen:
  • GBS-790052
Experimenteel: Treatment B: PSI-7977 + Daclatasvir
Genotype 2 or 3
Geneesmiddel: PSI-7977
Tablets, oral, 400 mg, once daily
Geneesmiddel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andere namen:
  • GBS-790052
Experimenteel: Treatment C: PSI-7977 + Daclatasvir
Genotype 1a or 1b
Geneesmiddel: PSI-7977
Tablets, oral, 400 mg, once daily
Geneesmiddel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andere namen:
  • GBS-790052
Experimenteel: Treatment D: PSI-7977 + Daclatasvir
Genotype 2 or 3
Geneesmiddel: PSI-7977
Tablets, oral, 400 mg, once daily
Geneesmiddel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andere namen:
  • GBS-790052
Experimenteel: Treatment E: PSI-7977 + Daclatasvir + Ribavirin
Genotype 1a or 1b
Geneesmiddel: PSI-7977
Tablets, oral, 400 mg, once daily
Geneesmiddel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andere namen:
  • GBS-790052
Geneesmiddel: Ribavirin
Tablets, oral, 200 mg
Andere namen:
  • Copegus ®
Experimenteel: Treatment F: PSI-7977 + Daclatasvir+ Ribavirin
Genotype 2 or 3
Geneesmiddel: PSI-7977
Tablets, oral, 400 mg, once daily
Geneesmiddel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andere namen:
  • GBS-790052
Geneesmiddel: Ribavirin
Tablets, oral, 200 mg
Andere namen:
  • Copegus ®
Experimenteel: Treatment G: PSI-7977 + Daclatasvir

Hepatitis C virus genotype 1, treatment-naive patients

Genotype 1a or 1b
Geneesmiddel: PSI-7977
Tablets, oral, 400 mg, once daily
Geneesmiddel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andere namen:
  • GBS-790052
Experimenteel: Treatment H: PSI-7977 + BMS-790052 + Ribavirin

Hepatitis C virus genotype 1, treatment-naive patients

Genotype 1a or 1b
Geneesmiddel: PSI-7977
Tablets, oral, 400 mg, once daily
Geneesmiddel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andere namen:
  • GBS-790052
Geneesmiddel: Ribavirin
Tablets, oral, 200 mg
Andere namen:
  • Copegus ®
Experimenteel: Treatment I: PSI-7977 + Daclatasvir

Patients who experienced telaprevir/boceprevir treatment failure

Genotype 1a or 1b
Geneesmiddel: PSI-7977
Tablets, oral, 400 mg, once daily
Geneesmiddel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andere namen:
  • GBS-790052
Experimenteel: Treatment J: PSI-7977 + Daclatasvir + Ribavirin

Patients who experienced telaprevir/boceprevir treatment failure

Genotype 1a or 1b
Geneesmiddel: PSI-7977
Tablets, oral, 400 mg, once daily
Geneesmiddel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andere namen:
  • GBS-790052
Geneesmiddel: Ribavirin
Tablets, oral, 200 mg
Andere namen:
  • Copegus ®

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Bristol-Myers Squibb

Medewerkers

Pharmasset

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2011

Primaire voltooiing (Werkelijk)

1 januari 2013

Studie voltooiing (Werkelijk)

1 oktober 2013

Studieregistratiedata

Eerst ingediend

23 mei 2011

Eerst ingediend dat voldeed aan de QC-criteria

24 mei 2011

Eerst geplaatst (Schatting)

25 mei 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

23 oktober 2015

Laatste update ingediend die voldeed aan QC-criteria

23 september 2015

Laatst geverifieerd

1 september 2015

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AI444-040

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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