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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. mai 2014 oppdatert av: 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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

202

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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
  • Forente stater
    • California
      • Coronado, California, Forente stater, 92118
        • Scti Research Foundation
      • Los Angeles, California, Forente stater, 90027
        • Kaiser Permanente
      • Los Angeles, California, Forente stater, 90036
        • Peter J. Ruane, MD, Inc.
      • Los Angeles, California, Forente stater, 90069
        • Anthony Mills MD, Inc.
      • San Diego, California, Forente stater, 92123
        • Medical Associates Research Group, Inc.
      • San Diego, California, Forente stater, 92103
        • UCSD Antiviral Research Center
      • San Diego, California, Forente stater, 92154
        • Kaiser Permanente
      • San Francisco, California, Forente stater, 94115
        • Quest Clinical Research
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • University of Colorado
      • Englewood, Colorado, Forente stater, 80113
        • South Denver Gastroenterology, PC
    • District of Columbia
      • Washington, District of Columbia, Forente stater, 20009
        • Whitman Walker Clinic
    • Florida
      • Gainesville, Florida, Forente stater, 32610-0277
        • University of Florida
      • Jacksonville, Florida, Forente stater, 32256
        • Borland-Groover Clinic Baptist
      • Miami, Florida, Forente stater, 33136
        • University of Miami
      • New Port Richey, Florida, Forente stater, 34653
        • Advanced Research Institute
      • Orlando, Florida, Forente stater, 32806
        • Internal Medicine Specialists
      • Orlando, Florida, Forente stater, 32803-1851
        • Orlando Immunology Center (ACH)
      • Wellington, Florida, Forente stater, 33414
        • South Florida Center of Gastroenterology, P.A.
    • Georgia
      • Atlanta, Georgia, Forente stater, 30309
        • Digestive Healthcare of Georgia
      • Marietta, Georgia, Forente stater, 30060
        • Gastrointestinal Specialists of Georgia, PC
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46237
        • Indianapolis Gastroenterology Research Foundation
    • Kentucky
      • Bowling Green, Kentucky, Forente stater, 42101
        • Graves-Gilbert Clinic
    • Louisiana
      • Baton Rouge, Louisiana, Forente stater, 70809
        • Gastroenterology Associates, Llc
    • Maryland
      • Lutherville, Maryland, Forente stater, 21093
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114-2696
        • Massachusetts General Hospital
      • Boston, Massachusetts, Forente stater, 02115
        • Beth Israel Deaconess Medical Center
      • Springfield, Massachusetts, Forente stater, 01105
        • The Research Institute
    • Michigan
      • Novi, Michigan, Forente stater, 48377
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, Forente stater, 55414
        • Minnesota Gastroenterology, P.A.
    • Missouri
      • Kansas City, Missouri, Forente stater, 64131
        • Kansas City Gastroenterology and Hepatology
    • New Jersey
      • Berlin, New Jersey, Forente stater, 08009
        • Comprehensive Clinical Research
      • Hillsborough, New Jersey, Forente stater, 08844
        • ID Care
    • New Mexico
      • Santa Fe, New Mexico, Forente stater, 87505
        • Southwest C.A.R.E. Center
    • New York
      • Binghamton, New York, Forente stater, 13903
        • Binghamton Gastroenterology Associates
      • New York, New York, Forente stater, 10029
        • Mount Sinai School of Medicine
    • North Carolina
      • Asheville, North Carolina, Forente stater, 28801
        • Asheville Gastroenterology Associates, P.A.
      • Durham, North Carolina, Forente stater, 27710
        • Duke University Medical Center
      • Winston-Salem, North Carolina, Forente stater, 27103
        • Digestive Health Specialists, PA
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19104
        • University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, Forente stater, 02906
        • The Miriam Hospital
      • Providence, Rhode Island, Forente stater, 02905
        • University Gastroenterology
    • Tennessee
      • Germantown, Tennessee, Forente stater, 38138
        • Gastro One
      • Nashville, Tennessee, Forente stater, 37211
        • Nashville Gastrointestinal Specialists, Inc
    • Texas
      • Arlington, Texas, Forente stater, 76012
        • Texas Clinical Research Institute, LLC
      • Dallas, Texas, Forente stater, 75219
        • Southwest Infectious Disease Clinical Research, Inc.
      • San Antonio, Texas, Forente stater, 78215
        • Alamo Medical Research
    • Virginia
      • Fairfax, Virginia, Forente stater, 22031
        • Metropolitan Research
      • Falls Church, Virginia, Forente stater, 22042
        • Inova Fairfax Hospital Center for Liver Diseases
      • Norfolk, Virginia, Forente stater, 23502
        • Digestive and Liver Disease Specialists
      • Richmond, Virginia, Forente stater, 23226
        • Bon Secours St. Mary's Hospital of Richmond, Inc.
    • Washington
      • Seattle, Washington, Forente 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: SOF
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
Andre navn:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Legemiddel: 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).
Legemiddel: Placebo to match SOF
Placebo to match SOF was administered orally once daily.
Legemiddel: Placebo to match RBV
Placebo to match RBV was administered orally twice daily.
Eksperimentell: SOF+RBV
Participants were randomized to receive SOF+RBV for 16 weeks.
Legemiddel: SOF
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
Andre navn:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Legemiddel: 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).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Gilead Sciences

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2012

Primær fullføring (Faktiske)

1. februar 2013

Studiet fullført (Faktiske)

1. mai 2013

Datoer for studieregistrering

Først innsendt

21. mai 2012

Først innsendt som oppfylte QC-kriteriene

22. mai 2012

Først lagt ut (Anslag)

24. mai 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

28. mai 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. mai 2014

Sist bekreftet

1. mai 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • GS-US-334-0108

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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