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Phase 3 Study of Sofosbuvir and Ribavirin (FISSION)

4. marts 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

527

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

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

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:

  • 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

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sofosbuvir+RBV
Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
Medicin: Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tabletter) indgivet oralt én gang dagligt
Andre navne:
  • GS-7977
  • PSI-7977
  • Sovaldi™
Medicin: 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.
Medicin: PEG
Pegyleret interferon alfa-2a (PEG) 180 μg administreret en gang om ugen ved subkutan injektion
Andre navne:
  • Pegasys®
Medicin: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
Tidsramme
Procentdel af deltagere med HCV RNA < LLOQ ved behandling
Tidsramme: Op til 12 uger
Op til 12 uger
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

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. december 2011

Primær færdiggørelse (Faktiske)

1. januar 2013

Studieafslutning (Faktiske)

1. april 2013

Datoer for studieregistrering

Først indsendt

19. december 2011

Først indsendt, der opfyldte QC-kriterier

21. december 2011

Først opslået (Skøn)

22. december 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

2. april 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. marts 2014

Sidst verificeret

1. marts 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • P7977-1231

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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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Croatia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner