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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 uppdaterad 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

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

350

Fas

  • Fas 2

Kontakter och platser

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

Studieorter

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

  • 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

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: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Treatment A: PSI-7977 + Daclatasvir
Genotype 1a or 1b
Läkemedel: PSI-7977
Tablets, oral, 400 mg, once daily
Läkemedel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andra namn:
  • BMS-790052
Experimentell: Treatment B: PSI-7977 + Daclatasvir
Genotype 2 or 3
Läkemedel: PSI-7977
Tablets, oral, 400 mg, once daily
Läkemedel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andra namn:
  • BMS-790052
Experimentell: Treatment C: PSI-7977 + Daclatasvir
Genotype 1a or 1b
Läkemedel: PSI-7977
Tablets, oral, 400 mg, once daily
Läkemedel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andra namn:
  • BMS-790052
Experimentell: Treatment D: PSI-7977 + Daclatasvir
Genotype 2 or 3
Läkemedel: PSI-7977
Tablets, oral, 400 mg, once daily
Läkemedel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andra namn:
  • BMS-790052
Experimentell: Treatment E: PSI-7977 + Daclatasvir + Ribavirin
Genotype 1a or 1b
Läkemedel: PSI-7977
Tablets, oral, 400 mg, once daily
Läkemedel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andra namn:
  • BMS-790052
Läkemedel: Ribavirin
Tablets, oral, 200 mg
Andra namn:
  • Copegus ®
Experimentell: Treatment F: PSI-7977 + Daclatasvir+ Ribavirin
Genotype 2 or 3
Läkemedel: PSI-7977
Tablets, oral, 400 mg, once daily
Läkemedel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andra namn:
  • BMS-790052
Läkemedel: Ribavirin
Tablets, oral, 200 mg
Andra namn:
  • Copegus ®
Experimentell: Treatment G: PSI-7977 + Daclatasvir

Hepatitis C virus genotype 1, treatment-naive patients

Genotype 1a or 1b
Läkemedel: PSI-7977
Tablets, oral, 400 mg, once daily
Läkemedel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andra namn:
  • BMS-790052
Experimentell: Treatment H: PSI-7977 + BMS-790052 + Ribavirin

Hepatitis C virus genotype 1, treatment-naive patients

Genotype 1a or 1b
Läkemedel: PSI-7977
Tablets, oral, 400 mg, once daily
Läkemedel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andra namn:
  • BMS-790052
Läkemedel: Ribavirin
Tablets, oral, 200 mg
Andra namn:
  • Copegus ®
Experimentell: Treatment I: PSI-7977 + Daclatasvir

Patients who experienced telaprevir/boceprevir treatment failure

Genotype 1a or 1b
Läkemedel: PSI-7977
Tablets, oral, 400 mg, once daily
Läkemedel: Daclatasvir
Tablets, oral, 60 mg, once daily
Andra namn:
  • BMS-790052
Experimentell: Treatment J: PSI-7977 + Daclatasvir + Ribavirin

Patients who experienced telaprevir/boceprevir treatment failure

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

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

Sponsor

Bristol-Myers Squibb

Samarbetspartners

Pharmasset

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.

Allmänna publikationer

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 juni 2011

Primärt slutförande (Faktisk)

1 januari 2013

Avslutad studie (Faktisk)

1 oktober 2013

Studieregistreringsdatum

Först inskickad

23 maj 2011

Först inskickad som uppfyllde QC-kriterierna

24 maj 2011

Första postat (Uppskatta)

25 maj 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

23 oktober 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 september 2015

Senast verifierad

1 september 2015

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • AI444-040

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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