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Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION) (FUSION)

9. maj 2014 opdateret af: Gilead Sciences

A Phase 3, Multicenter, Randomized, Double-Blind, Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection

This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus (HCV) infection as assessed by the proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

202

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary
      • Edmonton, Alberta, Canada, T6G 2X8
        • University of Alberta Hospital
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Gordon & Leslie Diamond Health Care Centre
      • Vancouver, British Columbia, Canada, V6Z 2C9
        • University of British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • (G.I.R.I.) Gastrointestinal Research Institute
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • University of Manitoba Health Sciences Center
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
      • Toronto, Ontario, Canada, M6H 3M1
        • Toronto Liver Centre
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
    • Quebec
      • Montreal, Quebec, Canada, H2X 3J4
        • Hopital St. Luc
  • Forenede Stater
    • California
      • Coronado, California, Forenede Stater, 92118
        • Scti Research Foundation
      • Los Angeles, California, Forenede Stater, 90027
        • Kaiser Permanente
      • Los Angeles, California, Forenede Stater, 90036
        • Peter J. Ruane, MD, Inc.
      • Los Angeles, California, Forenede Stater, 90069
        • Anthony Mills MD, Inc.
      • San Diego, California, Forenede Stater, 92123
        • Medical Associates Research Group, Inc.
      • San Diego, California, Forenede Stater, 92103
        • UCSD Antiviral Research Center
      • San Diego, California, Forenede Stater, 92154
        • Kaiser Permanente
      • 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, PC
    • 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 Baptist
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami
      • 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
      • Minneapolis, Minnesota, Forenede Stater, 55414
        • 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 Mexico
      • Santa Fe, New Mexico, Forenede Stater, 87505
        • Southwest C.A.R.E. Center
    • New York
      • Binghamton, New York, Forenede Stater, 13903
        • Binghamton Gastroenterology Associates
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai School of Medicine
    • North Carolina
      • Asheville, North Carolina, Forenede Stater, 28801
        • Asheville Gastroenterology Associates, P.A.
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University Medical Center
      • 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, 02906
        • The Miriam Hospital
      • 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
      • Arlington, Texas, Forenede Stater, 76012
        • Texas Clinical Research Institute, LLC
      • Dallas, Texas, Forenede Stater, 75219
        • Southwest Infectious Disease Clinical Research, Inc.
      • 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
      • Norfolk, Virginia, Forenede Stater, 23502
        • Digestive and Liver Disease Specialists
      • Richmond, Virginia, Forenede Stater, 23226
        • Bon Secours St. Mary's Hospital of Richmond, Inc.
    • 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
  • Had cirrhosis determination
  • Prior treatment failure
  • Screening laboratory values within defined thresholds
  • Subject had 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 have interfered 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+placebo
Participants were randomized to receive SOF+RBV for 12 weeks followed by placebo to match SOF plus placebo to match RBV for 4 weeks.
Medicin: SOF
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
Andre navne:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Medicin: RBV
Ribavirin (RBV) tablets was administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
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.
Eksperimentel: SOF+RBV
Participants were randomized to receive SOF+RBV for 16 weeks.
Medicin: SOF
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
Andre navne:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Medicin: RBV
Ribavirin (RBV) tablets was administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving SVR12
Tidsramme: Posttreatment Week 12

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy.

For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Posttreatment Week 12
Adverse Events Leading to Permanent Discontinuation of Study Drug
Tidsramme: Baseline to Week 16
Adverse events which led to permanent discontinuation of study drug may or may not have been related to study treatment.
Baseline to Week 16

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants Achieving SVR4
Tidsramme: Posttreatment Week 4

SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy.

For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Posttreatment Week 4
Percentage of Participants Achieving SVR24
Tidsramme: Posttreatment Week 24

SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy.

For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Posttreatment Week 24
Percentage of Participants With Viral Breakthrough
Tidsramme: Up to 16 weeks

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.

For the purposes of this efficacy analysis, assessments were made during active treatment (up to Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Up to 16 weeks
Percentage of Participants With Viral Relapse
Tidsramme: End of treatment to posttreatment 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.

For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
End of treatment to posttreatment 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. juni 2012

Primær færdiggørelse (Faktiske)

1. februar 2013

Studieafslutning (Faktiske)

1. maj 2013

Datoer for studieregistrering

Først indsendt

21. maj 2012

Først indsendt, der opfyldte QC-kriterier

22. maj 2012

Først opslået (Skøn)

24. maj 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. 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-334-0108

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 .

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