Sofosbuvir/Simeprevir Plus a Flat Dose of Ribavirin in Genotype 1 Elderly HCV Cirrhotic Patients
NCT ID: NCT02702739
Last Updated: 2016-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
270 participants
INTERVENTIONAL
2015-01-31
2016-02-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group I (<65 years)
Group I treated with Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks
Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks
Sofosbuvir 400 mg/day/Simeprevir 150 mg/day /Ribavirin 800/day for 12 weeks
Group II (>65 years)
Group II treated with Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks
Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks
Sofosbuvir 400 mg/day/Simeprevir 150 mg/day /Ribavirin 800/day for 12 weeks
Interventions
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Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks
Sofosbuvir 400 mg/day/Simeprevir 150 mg/day /Ribavirin 800/day for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
82 Years
ALL
No
Sponsors
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Azienda Ospedaliera San Camillo Forlanini
OTHER
Responsible Party
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Adriano Pellicelli
Director Liver Unit
Principal Investigators
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Adriano M Pellicelli, MD
Role: STUDY_DIRECTOR
AO San Camillo Forlanini ROme ITALY
Locations
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AO San Camillo Forlanini
Rome, Italy, Italy
Countries
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References
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Pellicelli AM, Romano M, Guarascio P, Vignally P. Which is the real efficacy of pegylated interferon alpha 2a or 2b plus ribavirin in HCV infected patients with advanced fibrosis? J Hepatol. 2012 Sep;57(3):704-5. doi: 10.1016/j.jhep.2012.03.008. Epub 2012 Apr 14. No abstract available.
Fontana RJ, Brown RS Jr, Moreno-Zamora A, Prieto M, Joshi S, Londono MC, Herzer K, Chacko KR, Stauber RE, Knop V, Jafri SM, Castells L, Ferenci P, Torti C, Durand CM, Loiacono L, Lionetti R, Bahirwani R, Weiland O, Mubarak A, ElSharkawy AM, Stadler B, Montalbano M, Berg C, Pellicelli AM, Stenmark S, Vekeman F, Ionescu-Ittu R, Emond B, Reddy KR. Daclatasvir combined with sofosbuvir or simeprevir in liver transplant recipients with severe recurrent hepatitis C infection. Liver Transpl. 2016 Apr;22(4):446-58. doi: 10.1002/lt.24416.
Pellicelli AM, Montalbano M, Lionetti R, Durand C, Ferenci P, D'Offizi G, Knop V, Telese A, Lenci I, Andreoli A, Zeuzem S, Angelico M. Sofosbuvir plus daclatasvir for post-transplant recurrent hepatitis C: potent antiviral activity but no clinical benefit if treatment is given late. Dig Liver Dis. 2014 Oct;46(10):923-7. doi: 10.1016/j.dld.2014.06.004. Epub 2014 Jul 3.
Pellicelli AM, Pace Palitti V, Vignally P, Ceccherini-Silberstein F, Siciliano M, Giannelli V, Moretti A, Tarquini P, Scifo G, Messina V, Ascione A, Izzi A, Marignani M, D'Ambrosio C, Fondacaro L, Ettorre GM, Ialongo P, Sacco R, Perno CF, Barbarini G; CLEO Group. Efficacy and safety of sofosbuvir/simeprevir plus flat dose ribavirin in genotype 1 elderly cirrhotic patients: A real-life study. Liver Int. 2017 May;37(5):653-661. doi: 10.1111/liv.13288. Epub 2016 Dec 15.
Other Identifiers
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FDAAA 801
Identifier Type: -
Identifier Source: org_study_id
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