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Phase 3 Study of Sofosbuvir and Ribavirin (FISSION)

4. mars 2014 oppdatert av: Gilead Sciences

A Phase 3, Multicenter, Randomized, Active-Controlled Study to Investigate the Safety and Efficacy of PSI-7977 and Ribavirin for 12 Weeks Compared to Pegylated Interferon and Ribavirin for 24 Weeks in Treatment-Naïve Patients With Chronic Genotype 2 or 3 HCV Infection

This study was to assess the safety and efficacy of sofosbuvir (GS-7977; PSI-7977) in combination with ribavirin (RBV) administered for 12 weeks compared with pegylated interferon (PEG)/RBV administered for 24 weeks in treatment-naive patients with Hepatitis C (HCV) genotype 2 or 3. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12). This was a non-inferiority study, and if non-inferiority was demonstrated, the study was then allowed to test for superiority.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

527

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Canberra Hospital
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Concord, New South Wales, Australia, 2137
        • Concord Repatriation General Hospital
      • Kogarah, New South Wales, Australia, 2217
        • St. George Hospital
    • Queensland
      • Greenslopes, Queensland, Australia, 4120
        • Gallipoli MRF
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane Hospital Research Foundation
      • Woollongabba, Queensland, Australia, 4102
        • Princess Alexandria
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Heidelberg, Victoria, Australia, 3084
        • Austin Hospital
      • Melbourne, Victoria, Australia, 3004
        • The Alfred
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Hospital
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner
      • Perth, Western Australia, Australia, 6000
        • Royal Perth Hospital
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • (G.I.R.I.) Gastrointestinal Research Institute
    • Ontario
      • Toronto, Ontario, Canada, M6H 3M1
        • Toronto Liver Centre
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
      • Toronto, Ontario, Canada, M5G 2N2
        • University Health Network-Toronto Western Hospital
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Toronto Digestive Disease Associates, Inc.
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35294
        • University of Alabama at Birmingham
      • Montgomery, Alabama, Forente stater, 36116
        • Alabama Liver & Digestive Specialist
    • California
      • Bakersfield, California, Forente stater, 93301
        • Franco Felizarta, MD
      • Beverly Hills, California, Forente stater, 90210
        • California Liver Institute
      • Colton, California, Forente stater, 92324
        • Arrowhead Regional Medical Center
      • Coronado, California, Forente stater, 92118
        • Scti Research Foundation
      • La Mesa, California, Forente stater, 91940
        • eStudy Site
      • Los Angeles, California, Forente stater, 90036
        • Peter J. Ruane, M.D. Inc.
      • Oceanside, California, Forente stater, 92056
        • eStudySite
      • Sacramento, California, Forente stater, 95817
        • University of California, Davis - Health System
      • San Diego, California, Forente stater, 92105
        • Research and Education, Inc.
      • San Diego, California, Forente stater, 92123
        • Medical Associates Research Group, Inc.
      • San Diego, California, Forente stater, 92103
        • University of California San Diego Medical Center
      • San Francisco, California, Forente stater, 94115
        • Quest Clinical Research
    • Colorado
      • Englewood, Colorado, Forente stater, 80113
        • South Denver Gastroenterology, PC
    • Florida
      • Bradenton, Florida, Forente stater, 34209
        • Pointe West Infectious Diseases
      • Fort Pierce, Florida, Forente stater, 34982
        • Midway Immunology & Research Center, LLC
      • Gainesville, Florida, Forente stater, 32610
        • University of Florida College of Medicine
      • Jacksonville, Florida, Forente stater, 32256
        • Borland-Groover Clinic Baptist
      • Miami, Florida, Forente stater, 33136
        • University of Miami, School of Medicine
      • Orlando, Florida, Forente stater, 32803
        • Orlando Immunology Center
      • Orlando, Florida, Forente stater, 32806
        • Internal Medicine Specialists
      • Trinity, Florida, Forente stater, 34655
        • Advanced Research Institute
      • Wellington, Florida, Forente stater, 33414
        • South Florida Center of Gastroenterology
    • Georgia
      • Atlanta, Georgia, Forente stater, 30308
        • Atlanta Gastroenterology Associates
      • Atlanta, Georgia, Forente stater, 30308
        • AIDS Research Consortium of Atlanta, Inc.
      • Marietta, Georgia, Forente stater, 30060
        • Gastrointestinal Specialists of Georgia, PC
    • Illinois
      • Chicago, Illinois, Forente stater, 60637
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46237
        • Indianapolis Gastroenterology Research Foundation
    • Maryland
      • Baltimore, Maryland, Forente stater, 21229
        • Digestive Disease Associates, P.A.
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02115
        • Beth Israel Deaconess Medical Center
      • Springfield, Massachusetts, Forente stater, 01105
        • The Research Institute
      • Worcester, Massachusetts, Forente stater, 01655
        • University of Massachusetts, Worcester
      • Worcester, Massachusetts, Forente stater, 01608-1320
        • Partners in Internal Medicine, PC
    • Michigan
      • Detroit, Michigan, Forente stater, 48202
        • Henry Ford Health System
    • Mississippi
      • Tupelo, Mississippi, Forente stater, 38801
        • Digestive Health Specialists, PA
    • New Jersey
      • East Orange, New Jersey, Forente stater, 07018
        • Veterans Affairs Medical Center
      • Egg Harbor Township, New Jersey, Forente stater, 08234
        • AGA Clinical Research Associates, LLC
      • Hillsborough, New Jersey, Forente stater, 08844
        • ID Care
      • Morristown, New Jersey, Forente stater, 07960
        • Atlantic Research Affiliates, LLC
    • New Mexico
      • Santa Fe, New Mexico, Forente stater, 87505
        • Southwest C.A.R.E. Center
    • New York
      • Manhasset, New York, Forente stater, 11030
        • North Shore University Hospital
      • New York, New York, Forente stater, 10029
        • Mount Sinai School of Medicine
      • New York, New York, Forente stater, 10021
        • Weill Cornell Medical College
      • Rochester, New York, Forente stater, 14662
        • University of Rochester
    • North Carolina
      • Asheville, North Carolina, Forente stater, 28801
        • Asheville Gastroenterology Associates, P.A.
      • Durham, North Carolina, Forente stater, 27710
        • Duke University Medical Center
      • Statesville, North Carolina, Forente stater, 28677
        • Carolinas Center For Liver Disease
      • Winston-Salem, North Carolina, Forente stater, 27103
        • Digestive Health Specialists, PA
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45267
        • University of Cincinnati
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74135
        • Gastroenterology United of Tulsa
    • Oregon
      • Medford, Oregon, Forente stater, 97504
        • Schleinitz Research and Gastroenterology LLC
    • Pennsylvania
      • Lancaster, Pennsylvania, Forente stater, 17604
        • Regional Gastroenterology Associates of Lancaster, Ltd.
      • Pittsburgh, Pennsylvania, Forente stater, 15213
        • UPMC Center for Liver Diseases
    • Rhode Island
      • Warwick, Rhode Island, Forente stater, 02886
        • 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, 75246
        • Baylor University Medical Center
      • Houston, Texas, Forente stater, 77030
        • Research Specialists of Texas
      • Houston, Texas, Forente stater, 77030
        • VAMC & Baylor College
      • Houston, Texas, Forente stater, 77005
        • Kelsey-Seybold Clinic PA
      • San Antonio, Texas, Forente stater, 78215
        • Alamo Medical Research
    • Virginia
      • Fairfax, Virginia, Forente stater, 22031
        • Metropolitan Research
      • Norfolk, Virginia, Forente stater, 23502
        • Digestive and Liver Disease Specialists
      • Norfolk, Virginia, Forente stater, 23502
        • Digestive and Liver Disease Specialist, Ltd.
    • Washington
      • Seattle, Washington, Forente stater, 98101
        • Virginia Mason Medical Center
  • Italia
      • San Giovanni Rotondo, Italia, 71013
        • Casa Sollievo della Sofferenza Hospital
  • Nederland
      • Amsterdam, Nederland, 1105 AZ
        • Academish Medisch Centrum
  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand
        • Auckland City Hospital
    • BOP
      • Tauranga, BOP, New Zealand, 3143
        • Tauranga Hospital
    • Canterbury
      • Chrischurch, Canterbury, New Zealand, 8001
        • Christchurch Hospital
    • OTA
      • Dunedin, OTA, New Zealand, 9010
        • Mercy Hospital
    • WGN
      • Newtown, WGN, New Zealand, 6021
        • Wellington Hospital
    • Waikato
      • Hamilton, Waikato, New Zealand, 3240
        • Waikato Hospital (District Health Board)
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Fundacion De Investigacion de Diego
  • Sverige
      • Göteborg, Sverige, 41685
        • Sahlgrenska Universitetssjukhuset, Östra Sjukhus
      • Stockholm, Sverige, 171 76
        • Karolinska Universitetssjukhuset, Solna

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:

  • Chronic Genotype 2 or 3 HCV-infection
  • Naive to all HCV antiviral treatment(s)

Exclusion Criteria:

  • Positive test at Screening for HBsAg, anti-hepatitis B core immunoglobulin M antibody (anti-HBc IgM Ab), or anti-HIV Ab
  • History of any other clinically significant chronic liver disease
  • A history consistent with decompensated liver disease
  • History or current evidence of psychiatric illness, immunologic disorder, hemoglobinopathy, pulmonary or cardiac disease, seizure disorder or anticonvulsant use, poorly controlled diabetes, cancer, or a history of malignancy, that makes the subject unsuitable for the study.
  • Participation in a clinical study within 3 months prior to first dose

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: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Sofosbuvir+RBV
Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
Legemiddel: Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tabletter) administrert oralt én gang daglig
Andre navn:
  • GS-7977
  • PSI-7977
  • Sovaldi™
Legemiddel: RBV

Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose

  • Dose of sofosbuvir+RBV group based on baseline weight: < 75kg = 1000 mg and ≥ 75 kg = 1200 mg
  • Dose of PEG+RBV group: 800 mg
Aktiv komparator: PEG+RBV
Participants were randomized to receive PEG+RBV for 24 weeks.
Legemiddel: KNAGG
Pegylert interferon alfa-2a (PEG) 180 μg administrert en gang ukentlig ved subkutan injeksjon
Andre navn:
  • Pegasys®
Legemiddel: RBV

Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose

  • Dose of sofosbuvir+RBV group based on baseline weight: < 75kg = 1000 mg and ≥ 75 kg = 1200 mg
  • Dose of PEG+RBV group: 800 mg

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants With Sustained Virologic Response 12 Weeks After Stopping All Study Drugs (SVR12)
Tidsramme: Post-treatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; < 25 IU/mL) 12 weeks after study drug cessation.
Post-treatment Week 12

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prosentandel av deltakere med HCV RNA < LLOQ ved behandling
Tidsramme: Opptil 12 uker
Opptil 12 uker
Number of Participants Who Experienced Adverse Events (AEs) and Graded Laboratory Abnormalities
Tidsramme: Up to 24 weeks plus 30 days following the last dose of study drug
Up to 24 weeks plus 30 days following the last dose of study drug
Percentage of Participants With Sustained Virologic Response 24 Weeks After Stopping All Study Drugs (SVR24)
Tidsramme: Post-treatment Week 24
SVR24 was defined as HCV RNA < LLOQ 24 weeks after study drug cessation.
Post-treatment Week 24
Change From Baseline in HCV RNA
Tidsramme: Baseline to Week 12
Baseline to Week 12
Percentage of Participants With Virologic Failure During Treatment
Tidsramme: Baseline up to Week 24

Virologic failure was defined as either

  • Viral breakthrough: HCV RNA ≥ 25 IU/mL after having previously had HCV RNA < 25 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement
  • Viral rebound: > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement
  • Non-response: HCV RNA persistently ≥ 25 IU/ml while on treatment (through Week 12)
Baseline up to Week 24
Percentage of Participants With Viral Relapse Following Treatment
Tidsramme: Up to Post-treatment Week 24
Viral relapse was defined as HCV RNA ≥ 25 IU/mL in post-treatment after having achieved < LLOQ at last on-treatment measurement, confirmed with 2 consecutive values or last available measurement.
Up to Post-treatment 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. desember 2011

Primær fullføring (Faktiske)

1. januar 2013

Studiet fullført (Faktiske)

1. april 2013

Datoer for studieregistrering

Først innsendt

19. desember 2011

Først innsendt som oppfylte QC-kriteriene

21. desember 2011

Først lagt ut (Anslag)

22. desember 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

2. april 2014

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. mars 2014

Sist bekreftet

1. mars 2014

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • P7977-1231

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. .

Kliniske studier på Hepatitt C

Kliniske studier på KNAGG

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Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Latvia

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

Abonnere