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Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon (POSITRON)

8. maj 2014 opdateret af: Gilead Sciences

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 HCV Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon

This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to match SOF+placebo to match RBV. Randomization was stratified by presence/absence of cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Participants who were randomized to the placebo arm and completed all scheduled study procedures were eligible to receive active SOF+RBV in open-label Study GS-US-334-0109.

Participants who do not achieve sustained virologic response (SVR) were eligible for enrollment in the Sequence Registry Study GS-US-248-0123. The purpose of the Sequence Registry Study is to monitor the persistence of resistant mutations for up to 3 years.

Participants who achieved SVR were eligible for enrollment in the SVR Registry Study GS-US-248-0122. The purpose of the SVR Registry Study is to evaluate durability of SVR for up to 3 years after treatment.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

278

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Australien
      • Melbourne, Australien, 3168
        • Monash Medical Centre
      • Melbourne, Australien, 3065
        • St. Vincent's Hospital
    • New South Wales
      • Westmead,, New South Wales, Australien, 2145
        • Westmead Hospital
    • Queensland
      • Herston, Queensland, Australien, 4029
        • Royal Brisbane & Women's Hospital
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University Of Calgary
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Gordon & Leslie Diamond Health Care Centre
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • (G.I.R.I.) Gastrointestinal Research Institute
    • Ontario
      • Toronto, Ontario, Canada, M6H 3M1
        • Toronto Liver Centre
    • Quebec
      • Montreal, Quebec, Canada, H2X 3J4
        • CHUM - The Research Centre
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294-2170
        • University of Alabama Birmingham
    • California
      • Coronado, California, Forenede Stater, 92118
        • SCTI Research Foundation Liver Center
      • Los Angeles, California, Forenede Stater, 90027
        • Kaiser Permanente
      • Los Angeles, California, Forenede Stater, 90069
        • Anthony Mills MD, Inc.
      • Los Angeles, California, Forenede Stater, 90036
        • Lightspeed Medical
      • San Diego, California, Forenede Stater, 92103
        • UCSD Antiviral Research Center
      • San Diego, California, Forenede Stater, 92154
        • Kaiser Permanente
      • San Diego, California, Forenede Stater, 912123
        • Medical Associates Research Group
      • San Francisco, California, Forenede Stater, 94115
        • Quest Clinical Research
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • University of Colorado
      • Englewood, Colorado, Forenede Stater, 80113
        • South Denver Gastroenterology
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20009
        • Whitman Walker Clinic
    • Florida
      • Gainesville, Florida, Forenede Stater, 32610-0277
        • University of Florida
      • Jacksonville, Florida, Forenede Stater, 32256
        • Borland-Groover Clinic
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami, Center for Liver Diseases
      • New Port Richey, Florida, Forenede Stater, 34653
        • Advanced Research Institute
      • Orlando, Florida, Forenede Stater, 32806
        • Internal Medicine Specialists
      • Orlando, Florida, Forenede Stater, 32803-1851
        • Orlando Immunology Center (ACH)
      • Wellington, Florida, Forenede Stater, 33414
        • South Florida Center of Gastroenterology, P.A.
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30309
        • Digestive Healthcare of Georgia
      • Marietta, Georgia, Forenede Stater, 30060
        • Gastrointestinal Specialists of Georgia, PC
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46237
        • Indianapolis Gastroenterology Research Foundation
    • Kentucky
      • Bowling Green, Kentucky, Forenede Stater, 42101
        • Graves-Gilbert Clinic
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70809
        • Gastroenterology Associates, LLC
    • Maryland
      • Lutherville, Maryland, Forenede Stater, 21093
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114-2696
        • Massachusetts General Hospital
      • Boston, Massachusetts, Forenede Stater, 02115
        • Beth Israel Deaconess Medical Center
      • Springfield, Massachusetts, Forenede Stater, 01105
        • The Research Institute
    • Michigan
      • Novi, Michigan, Forenede Stater, 48377
        • Henry Ford Health System
    • Minnesota
      • St. Paul, Minnesota, Forenede Stater, 55407
        • Minnesota Gastroenterology, P.A.
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64131
        • Kansas City Gastroenterology and Hepatology
    • New Jersey
      • Berlin, New Jersey, Forenede Stater, 08009
        • Comprehensive Clinical Research
      • Hillsborough, New Jersey, Forenede Stater, 08844
        • ID care
    • New York
      • Binghamton, New York, Forenede Stater, 13903
        • Binghamton Gastroenterology Associates
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai School of Medicine
      • New York, New York, Forenede Stater, 10021
        • Weill Cornell Medical College
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University
      • Winston-Salem, North Carolina, Forenede Stater, 27103
        • Digestive Health Specialists, PA
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02905
        • University Gastroenterology
    • Tennessee
      • Germantown, Tennessee, Forenede Stater, 38138
        • Gastro One
      • Nashville, Tennessee, Forenede Stater, 37211
        • Nashville Gastrointestinal Specialists, Inc
    • Texas
      • Dallas, Texas, Forenede Stater, 75219
        • Southwest Infectious Disease Clinical Research, Inc.
      • Houston, Texas, Forenede Stater, 77004
        • Therapeutic Concepts, PA
      • San Antonio, Texas, Forenede Stater, 78215
        • Alamo Medical Research
    • Virginia
      • Fairfax, Virginia, Forenede Stater, 22031
        • Metropolitan Research
      • Falls Church, Virginia, Forenede Stater, 22042
        • Inova Fairfax Hospital Center for Liver Diseases
      • Newport News, Virginia, Forenede Stater, 23602
        • Liver Institute of Virginia, Bon Secours St.Mary's
      • Norfolk, Virginia, Forenede Stater, 23502
        • Digestive and Liver Disease Specialists
    • Washington
      • Seattle, Washington, Forenede Stater, 98101
        • Virginia Mason Medical Center
  • New Zealand
      • Auckland, New Zealand, 1640
        • Auckland Clinical Studies Limited
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Fundacion De Investigacion de Diego
      • San Juan, Puerto Rico, 00909-1711
        • Clinical Research Puerto Rico Inc

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:

  • Infection with HCV genotype 2 or 3
  • Cirrhosis determination

  • Subject meets one of the following classifications:

    1. IFN unwilling
    2. IFN ineligible
    3. IFN intolerant
  • Screening laboratory values within defined thresholds
  • Subject has not been treated with any investigational drug or device within 30 days of the Screening visit
  • Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

  • Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
  • Pregnant or nursing female or male with pregnant female partner
  • Current or prior history of clinical hepatic decompensation
  • History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
  • Excessive alcohol ingestion or significant drug abuse

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: SOF+RBV
Participants were randomized to receive SOF+RBV for 12 weeks.
Medicin: SOF
Sofosbuvir (SOF) 400 mg tablet indgivet oralt én gang dagligt
Andre navne:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Medicin: RBV
Ribavirin (RBV) was administered as a tablet orally according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Placebo komparator: Placebo
Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks.
Medicin: Placebo to match SOF
Placebo to match SOF was administered orally once daily.
Medicin: Placebo to match RBV
Placebo to match RBV was administered orally twice daily.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving SVR12
Tidsramme: Post-treatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy
Post-treatment Week 12
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Tidsramme: Baseline to Week 12
The number of subjects experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment.
Baseline to Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving SVR4
Tidsramme: Post-treatment Week 4
SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy
Post-treatment Week 4
Percentage of Participants Achieving SVR24
Tidsramme: Post-treatment Week 24
SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy
Post-treatment Week 24
Percentage of Participants Experiencing Viral Breakthrough
Tidsramme: Baseline to Week 12
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values
Baseline to Week 12
Percentage of Participants Experiencing Viral Relapse
Tidsramme: End of treatment to post-treatment Week 24
Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement
End of treatment to post-treatment Week 24

Samarbejdspartnere og efterforskere

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

Sponsor

Gilead Sciences

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

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. marts 2012

Primær færdiggørelse (Faktiske)

1. november 2012

Studieafslutning (Faktiske)

1. februar 2013

Datoer for studieregistrering

Først indsendt

17. februar 2012

Først indsendt, der opfyldte QC-kriterier

1. marts 2012

Først opslået (Skøn)

2. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

19. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. maj 2014

Sidst verificeret

1. maj 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • GS-US-334-0107

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 .

Abonner