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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 maggio 2014 aggiornato da: 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).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

202

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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
  • Nuova Zelanda
      • Auckland, Nuova Zelanda, 1640
        • Auckland Clinical Studies Limited
      • Christchurch, Nuova Zelanda, 8011
        • Christchurch Hospital
  • Porto Rico
      • San Juan, Porto Rico, 00927
        • Fundacion De Investigacion de Diego
      • San Juan, Porto Rico, 00909-1711
        • Clinical Research Puerto Rico Inc
  • Stati Uniti
    • California
      • Coronado, California, Stati Uniti, 92118
        • Scti Research Foundation
      • Los Angeles, California, Stati Uniti, 90027
        • Kaiser Permanente
      • Los Angeles, California, Stati Uniti, 90036
        • Peter J. Ruane, MD, Inc.
      • Los Angeles, California, Stati Uniti, 90069
        • Anthony Mills MD, Inc.
      • San Diego, California, Stati Uniti, 92123
        • Medical Associates Research Group, Inc.
      • San Diego, California, Stati Uniti, 92103
        • UCSD Antiviral Research Center
      • San Diego, California, Stati Uniti, 92154
        • Kaiser Permanente
      • San Francisco, California, Stati Uniti, 94115
        • Quest Clinical Research
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • University of Colorado
      • Englewood, Colorado, Stati Uniti, 80113
        • South Denver Gastroenterology, PC
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20009
        • Whitman Walker Clinic
    • Florida
      • Gainesville, Florida, Stati Uniti, 32610-0277
        • University of Florida
      • Jacksonville, Florida, Stati Uniti, 32256
        • Borland-Groover Clinic Baptist
      • Miami, Florida, Stati Uniti, 33136
        • University of Miami
      • New Port Richey, Florida, Stati Uniti, 34653
        • Advanced Research Institute
      • Orlando, Florida, Stati Uniti, 32806
        • Internal Medicine Specialists
      • Orlando, Florida, Stati Uniti, 32803-1851
        • Orlando Immunology Center (ACH)
      • Wellington, Florida, Stati Uniti, 33414
        • South Florida Center of Gastroenterology, P.A.
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30309
        • Digestive Healthcare of Georgia
      • Marietta, Georgia, Stati Uniti, 30060
        • Gastrointestinal Specialists of Georgia, PC
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46237
        • Indianapolis Gastroenterology Research Foundation
    • Kentucky
      • Bowling Green, Kentucky, Stati Uniti, 42101
        • Graves-Gilbert Clinic
    • Louisiana
      • Baton Rouge, Louisiana, Stati Uniti, 70809
        • Gastroenterology Associates, LLC
    • Maryland
      • Lutherville, Maryland, Stati Uniti, 21093
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02114-2696
        • Massachusetts General Hospital
      • Boston, Massachusetts, Stati Uniti, 02115
        • Beth Israel Deaconess Medical Center
      • Springfield, Massachusetts, Stati Uniti, 01105
        • The Research Institute
    • Michigan
      • Novi, Michigan, Stati Uniti, 48377
        • Henry Ford Health System
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55414
        • Minnesota Gastroenterology, P.A.
    • Missouri
      • Kansas City, Missouri, Stati Uniti, 64131
        • Kansas City Gastroenterology and Hepatology
    • New Jersey
      • Berlin, New Jersey, Stati Uniti, 08009
        • Comprehensive Clinical Research
      • Hillsborough, New Jersey, Stati Uniti, 08844
        • ID Care
    • New Mexico
      • Santa Fe, New Mexico, Stati Uniti, 87505
        • Southwest C.A.R.E. Center
    • New York
      • Binghamton, New York, Stati Uniti, 13903
        • Binghamton Gastroenterology Associates
      • New York, New York, Stati Uniti, 10029
        • Mount Sinai School of Medicine
    • North Carolina
      • Asheville, North Carolina, Stati Uniti, 28801
        • Asheville Gastroenterology Associates, P.A.
      • Durham, North Carolina, Stati Uniti, 27710
        • Duke University Medical Center
      • Winston-Salem, North Carolina, Stati Uniti, 27103
        • Digestive Health Specialists, PA
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02906
        • The Miriam Hospital
      • Providence, Rhode Island, Stati Uniti, 02905
        • University Gastroenterology
    • Tennessee
      • Germantown, Tennessee, Stati Uniti, 38138
        • Gastro One
      • Nashville, Tennessee, Stati Uniti, 37211
        • Nashville Gastrointestinal Specialists, Inc
    • Texas
      • Arlington, Texas, Stati Uniti, 76012
        • Texas Clinical Research Institute, LLC
      • Dallas, Texas, Stati Uniti, 75219
        • Southwest Infectious Disease Clinical Research, Inc.
      • San Antonio, Texas, Stati Uniti, 78215
        • Alamo Medical Research
    • Virginia
      • Fairfax, Virginia, Stati Uniti, 22031
        • Metropolitan Research
      • Falls Church, Virginia, Stati Uniti, 22042
        • Inova Fairfax Hospital Center for Liver Diseases
      • Norfolk, Virginia, Stati Uniti, 23502
        • Digestive and Liver Disease Specialists
      • Richmond, Virginia, Stati Uniti, 23226
        • Bon Secours St. Mary's Hospital of Richmond, Inc.
    • Washington
      • Seattle, Washington, Stati Uniti, 98101
        • Virginia Mason Medical Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: SOF
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
Altri nomi:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Droga: 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).
Droga: Placebo to match SOF
Placebo to match SOF was administered orally once daily.
Droga: Placebo to match RBV
Placebo to match RBV was administered orally twice daily.
Sperimentale: SOF+RBV
Participants were randomized to receive SOF+RBV for 16 weeks.
Droga: SOF
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
Altri nomi:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Droga: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Achieving SVR12
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Achieving SVR4
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Gilead Sciences

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2012

Completamento primario (Effettivo)

1 febbraio 2013

Completamento dello studio (Effettivo)

1 maggio 2013

Date di iscrizione allo studio

Primo inviato

21 maggio 2012

Primo inviato che soddisfa i criteri di controllo qualità

22 maggio 2012

Primo Inserito (Stima)

24 maggio 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

28 maggio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 maggio 2014

Ultimo verificato

1 maggio 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • GS-US-334-0108

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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