Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION) (FUSION)
9 mai 2014 mis à jour par: 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).
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
202
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
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
-
-
-
-
-
Auckland, Nouvelle-Zélande, 1640
- Auckland Clinical Studies Limited
-
Christchurch, Nouvelle-Zélande, 8011
- Christchurch Hospital
-
-
-
-
-
San Juan, Porto Rico, 00927
- Fundacion De Investigacion de Diego
-
San Juan, Porto Rico, 00909-1711
- Clinical Research Puerto Rico Inc
-
-
-
-
California
-
Coronado, California, États-Unis, 92118
- Scti Research Foundation
-
Los Angeles, California, États-Unis, 90027
- Kaiser Permanente
-
Los Angeles, California, États-Unis, 90036
- Peter J. Ruane, MD, Inc.
-
Los Angeles, California, États-Unis, 90069
- Anthony Mills MD, Inc.
-
San Diego, California, États-Unis, 92123
- Medical Associates Research Group, Inc.
-
San Diego, California, États-Unis, 92103
- UCSD Antiviral Research Center
-
San Diego, California, États-Unis, 92154
- Kaiser Permanente
-
San Francisco, California, États-Unis, 94115
- Quest Clinical Research
-
-
Colorado
-
Aurora, Colorado, États-Unis, 80045
- University of Colorado
-
Englewood, Colorado, États-Unis, 80113
- South Denver Gastroenterology, PC
-
-
District of Columbia
-
Washington, District of Columbia, États-Unis, 20009
- Whitman Walker Clinic
-
-
Florida
-
Gainesville, Florida, États-Unis, 32610-0277
- University of Florida
-
Jacksonville, Florida, États-Unis, 32256
- Borland-Groover Clinic Baptist
-
Miami, Florida, États-Unis, 33136
- University of Miami
-
New Port Richey, Florida, États-Unis, 34653
- Advanced Research Institute
-
Orlando, Florida, États-Unis, 32806
- Internal Medicine Specialists
-
Orlando, Florida, États-Unis, 32803-1851
- Orlando Immunology Center (ACH)
-
Wellington, Florida, États-Unis, 33414
- South Florida Center of Gastroenterology, P.A.
-
-
Georgia
-
Atlanta, Georgia, États-Unis, 30309
- Digestive Healthcare of Georgia
-
Marietta, Georgia, États-Unis, 30060
- Gastrointestinal Specialists of Georgia, PC
-
-
Indiana
-
Indianapolis, Indiana, États-Unis, 46237
- Indianapolis Gastroenterology Research Foundation
-
-
Kentucky
-
Bowling Green, Kentucky, États-Unis, 42101
- Graves-Gilbert Clinic
-
-
Louisiana
-
Baton Rouge, Louisiana, États-Unis, 70809
- Gastroenterology Associates, LLC
-
-
Maryland
-
Lutherville, Maryland, États-Unis, 21093
- Johns Hopkins University
-
-
Massachusetts
-
Boston, Massachusetts, États-Unis, 02114-2696
- Massachusetts General Hospital
-
Boston, Massachusetts, États-Unis, 02115
- Beth Israel Deaconess Medical Center
-
Springfield, Massachusetts, États-Unis, 01105
- The Research Institute
-
-
Michigan
-
Novi, Michigan, États-Unis, 48377
- Henry Ford Health System
-
-
Minnesota
-
Minneapolis, Minnesota, États-Unis, 55414
- Minnesota Gastroenterology, P.A.
-
-
Missouri
-
Kansas City, Missouri, États-Unis, 64131
- Kansas City Gastroenterology and Hepatology
-
-
New Jersey
-
Berlin, New Jersey, États-Unis, 08009
- Comprehensive Clinical Research
-
Hillsborough, New Jersey, États-Unis, 08844
- ID care
-
-
New Mexico
-
Santa Fe, New Mexico, États-Unis, 87505
- Southwest C.A.R.E. Center
-
-
New York
-
Binghamton, New York, États-Unis, 13903
- Binghamton Gastroenterology Associates
-
New York, New York, États-Unis, 10029
- Mount Sinai School of Medicine
-
-
North Carolina
-
Asheville, North Carolina, États-Unis, 28801
- Asheville Gastroenterology Associates, P.A.
-
Durham, North Carolina, États-Unis, 27710
- Duke University Medical Center
-
Winston-Salem, North Carolina, États-Unis, 27103
- Digestive Health Specialists, PA
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, États-Unis, 19104
- University of Pennsylvania
-
-
Rhode Island
-
Providence, Rhode Island, États-Unis, 02906
- The Miriam Hospital
-
Providence, Rhode Island, États-Unis, 02905
- University Gastroenterology
-
-
Tennessee
-
Germantown, Tennessee, États-Unis, 38138
- Gastro One
-
Nashville, Tennessee, États-Unis, 37211
- Nashville Gastrointestinal Specialists, Inc
-
-
Texas
-
Arlington, Texas, États-Unis, 76012
- Texas Clinical Research Institute, LLC
-
Dallas, Texas, États-Unis, 75219
- Southwest Infectious Disease Clinical Research, Inc.
-
San Antonio, Texas, États-Unis, 78215
- Alamo Medical Research
-
-
Virginia
-
Fairfax, Virginia, États-Unis, 22031
- Metropolitan Research
-
Falls Church, Virginia, États-Unis, 22042
- Inova Fairfax Hospital Center for Liver Diseases
-
Norfolk, Virginia, États-Unis, 23502
- Digestive and Liver Disease Specialists
-
Richmond, Virginia, États-Unis, 23226
- Bon Secours St. Mary's Hospital of Richmond, Inc.
-
-
Washington
-
Seattle, Washington, États-Unis, 98101
- Virginia Mason Medical Center
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
Autres noms:
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).
Placebo to match SOF was administered orally once daily.
Placebo to match RBV was administered orally twice daily.
|
|
Expérimental: SOF+RBV
Participants were randomized to receive SOF+RBV for 16 weeks.
|
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
Autres noms:
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).
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Participants Achieving SVR12
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Participants Achieving SVR4
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Younossi ZM, Stepanova M, Sulkowski M, Naggie S, Puoti M, Orkin C, Hunt SL. Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected With Hepatitis C Virus and HIV: The Impact on Patient-Reported Outcomes. J Infect Dis. 2015 Aug 1;212(3):367-77. doi: 10.1093/infdis/jiv005. Epub 2015 Jan 12.
- Stepanova M, Nader F, Cure S, Bourhis F, Hunt S, Younossi ZM. Patients' preferences and health utility assessment with SF-6D and EQ-5D in patients with chronic hepatitis C treated with sofosbuvir regimens. Aliment Pharmacol Ther. 2014 Sep;40(6):676-85. doi: 10.1111/apt.12880. Epub 2014 Jul 15.
- Jacobson IM, Gordon SC, Kowdley KV, Yoshida EM, Rodriguez-Torres M, Sulkowski MS, Shiffman ML, Lawitz E, Everson G, Bennett M, Schiff E, Al-Assi MT, Subramanian GM, An D, Lin M, McNally J, Brainard D, Symonds WT, McHutchison JG, Patel K, Feld J, Pianko S, Nelson DR; POSITRON Study; FUSION Study. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med. 2013 May 16;368(20):1867-77. doi: 10.1056/NEJMoa1214854. Epub 2013 Apr 23.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juin 2012
Achèvement primaire (Réel)
1 février 2013
Achèvement de l'étude (Réel)
1 mai 2013
Dates d'inscription aux études
Première soumission
21 mai 2012
Première soumission répondant aux critères de contrôle qualité
22 mai 2012
Première publication (Estimation)
24 mai 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
28 mai 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
9 mai 2014
Dernière vérification
1 mai 2014
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Infections par virus à ARN
- Maladies virales
- Infections
- Infections transmissibles par le sang
- Maladies transmissibles
- Maladies du foie
- Infections à Flaviviridae
- Hépatite, virale, humaine
- Hépatite chronique
- Hépatite
- Hépatite C
- Hépatite C chronique
- Agents anti-infectieux
- Agents antiviraux
- Sofosbuvir
Autres numéros d'identification d'étude
- GS-US-334-0108
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .