Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection
NCT ID: NCT01682720
Last Updated: 2014-10-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
421 participants
INTERVENTIONAL
2012-09-30
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo 12 Weeks (GT2/3)
Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
Placebo to match SOF
Placebo to match SOF administered orally once daily
Placebo to match RBV
Placebo to match RBV administered orally in a divided daily dose
SOF 12 Weeks (GT2/3)
Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
RBV
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
SOF 24 Weeks (GT3)
SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
RBV
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Interventions
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SOF
Sofosbuvir (SOF) 400 mg tablet administered orally once daily
RBV
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Placebo to match SOF
Placebo to match SOF administered orally once daily
Placebo to match RBV
Placebo to match RBV administered orally in a divided daily dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCV RNA \> 10,000 IU/mL at screening
* Subjects must be treatment naive or treatment experienced
* Presence or absence of cirrhosis; a liver biopsy may be required
* Healthy according to medical history and physical examination with the exception of HCV diagnosis
* Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication
Exclusion Criteria
* History of any other clinically significant chronic liver disease
* Evidence of or history of decompensated liver disease
* HIV or chronic hepatitis B virus (HBV) infection
* Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
* Chronic use of immunosuppressive agents or immunomodulatory agents
* History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study or not be in the best interest of the subject in the opinion of the investigator
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Rob Hyland, DPhil
Role: STUDY_DIRECTOR
Gilead Sciences Study Director
Locations
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Medizinische Universitat Graz
Graz, , Austria
Medizinische Universitat Wien
Vienna, , Austria
Wilhelminenspital
Vienna, , Austria
West Tallinn Central Hospital
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
CHRU de Lille, Hopital Claude Huriez
CHRU Lille, , France
CHU Estaing
Clermont-Ferrand, , France
Hopital Beaujon
Clichy, , France
Hopital Henri Mondor
Créteil, , France
Département Hépatogastroentérologie - CHU de Grenoble
Grenoble, , France
Hopital Saint Joseph
Marseille, , France
Hopital Saint Eloi
Montpellier, , France
Hopital de l Archet 2
Nice, , France
Hopital Saint Antoine
Paris, , France
Hopital Pitie Salpetriere
Paris, , France
Hopitaux Universitaires
Paris, , France
Groupe Hospitalier Sud - Hôpital Haut-Lévêque - USN
Pessac, , France
CHU Pontchaillou - Hématologie Clinique
Rennes, , France
Centre Hospitalier Universitaire de Strasbourg
Strasbourg, , France
CHU de Nancy, Hôpital de Brabois
Vandœuvre-lès-Nancy, , France
Praxiszentrum
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Leber- and Studienzentrum am Checkpoint
Berlin, , Germany
Universitaetsklinikum Bonn
Bonn, , Germany
Heinrich Heine Unversitat
Düsseldorf, , Germany
JWG-Universität Frankfurt
Frankfurt am Main, , Germany
Asklepios Klinik Sankt Georg H
Hamburg, , Germany
Universitatsklinikum
Hamburg, , Germany
Medizinische Hochschule Hannov
Hanover, , Germany
Medizinische Klinik IV, Dep. o
Heidelberg, , Germany
Gastroenterologische Gemeinsch
Herne, , Germany
Leberstudienzentrum Kiel
Kiel, , Germany
Universitaetsklinikum Leipzig
Leipzig, , Germany
Klinikum der Universität Münch
München, , Germany
Centrum fuer interdisziplinaere Medizin Muenster GmbH
Münster, , Germany
Ospedale Casa Sollievo
San Giovanni Rotondo, Foggia, Italy
Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi
Bologna, , Italy
Ospedale S. Annunziata
Florence, , Italy
Ente Ospedaliero Ospedali Galliera
Genova, , Italy
Fondazione IRCCS CA Granada - Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera Ospedale Niguarda Cà Granda
Milan, , Italy
University of Padova
Padua, , Italy
University of Palermo
Palermo, , Italy
Azienda Ospedaliero Universitaria di Parma
Parma, , Italy
Fondazione PTV - Policlinico Tor Vergata
Roma, , Italy
INMI "Lazzaro Spallanzani" I.R.C.C.S.
Roma, , Italy
Azienda Ospedaliera Universitaria San Giovanni Battista di Torino
Torino, , Italy
Academisch Medisch Centrum
Amsterdam, , Netherlands
Leids Universitair Medisch Centrum
Leiden, , Netherlands
UMC St. Radboud - Gastroenterology
Nijmegen, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Wojewodzki Szpital Specjalistyczny im Dluskeigo
Bialystok, , Poland
Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
Lodz, , Poland
SP ZOZ Wojewodzki Szpital Zakazny w Warszawie
Warsaw, , Poland
NZOZ Centrum Badan Klinicznych
Wroclaw, , Poland
Hospital Universitari Vall d'H
Barcelona, , Spain
Hospital Casa de la Maternidad
Barcelona, , Spain
Hospital Carlos III
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Puerta de Hierro Maja
Majadahonda, , Spain
Complejo Hospitalario de Especialidades Virgen de la Victoria
Málaga, , Spain
Hospital Universitario Marques
Santander, , Spain
Valme Hospital
Seville, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Sahlgrenska University Hospital
Gothenburg, , Sweden
Skånes Universitetssjukhus, Lund
Lund, , Sweden
Skanes Universitetssjukhus
Malmo, , Sweden
Karolinska Instituet
Stockholm, , Sweden
University of Birmingham
Edgbaston, Birmingham, United Kingdom
Southampton University Hospital NHS Trust
Southhampton, Hampshire, United Kingdom
King's College Hospital
Denmark Hill, London, United Kingdom
The Liver Unit
Paddington, London, United Kingdom
North Manchester General Hospital
Crumpsall, Manchester, United Kingdom
Bristol Royal Infirmary
Bristol, , United Kingdom
Queen Marys University of London
London, , United Kingdom
Royal Free Hospital and University College London Hospital
London, , United Kingdom
Chelsea & Westminster Hospital
London, , United Kingdom
Nottingham University Hospitals-NHS
Nottingham, , United Kingdom
Countries
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References
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Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, Illeperuma A, Svarovskaia E, Brainard DM, Symonds WT, Subramanian GM, McHutchison JG, Weiland O, Reesink HW, Ferenci P, Hezode C, Esteban R; VALENCE Investigators. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med. 2014 May 22;370(21):1993-2001. doi: 10.1056/NEJMoa1316145. Epub 2014 May 4.
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.
Other Identifiers
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2012-001942-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-334-0133
Identifier Type: -
Identifier Source: org_study_id
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