Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease
NCT ID: NCT03036852
Last Updated: 2020-03-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
59 participants
INTERVENTIONAL
2017-03-22
2018-11-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SOF/VEL
SOF/VEL for 12 weeks
SOF/VEL
400/100 mg fixed-dose combination (FDC) tablet(s) administered orally once daily
Interventions
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SOF/VEL
400/100 mg fixed-dose combination (FDC) tablet(s) administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Royal Adelaide Hospital
Adelaide, South Australia, Australia
Kaye Edmonton Clinic
Edmonton, Alberta, Canada
Gordon and Leslie Diamond Health Care Center, Vancouver General Hospital, UBC Division of Gastroenterology
Vancouver, British Columbia, Canada
William Osler Health System- Brampton Civic Hospital
Brampton, Ontario, Canada
Hamilton Health Sciences - McMaster University Medical Centre Site
Hamilton, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)
Montreal, Quebec, Canada
Shaare Zedek Medical Center
Jerusalem, , Israel
The Chaim Sheba Medical Centre
Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Auckland City Hospital
Grafton, Auckland, New Zealand
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Gartnavel General Hospital
Glasgow, , United Kingdom
Barts Health NHS Trust
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Chelsea and Westminster Hospital
London, , United Kingdom
Imperial College Healthcare NHS Trust
London, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Countries
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References
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Borgia SM, Dearden J, Lurie Y, Shafran SD, Brown A, Hyland RH, et al. Sofosbuvir/Velpatasvir for 12 Weeks Is Safe and Effective in Patients Undergoing Dialysis. American Association for the Study of Liver Diseases (AASLD); 2018 09-13 November; San Francisco, CA.
Borgia SM, Dearden J, Yoshida EM, Shafran SD, Brown A, Ben-Ari Z, Cramp ME, Cooper C, Foxton M, Rodriguez CF, Esteban R, Hyland R, Lu S, Kirby BJ, Meng A, Markova S, Dvory-Sobol H, Osinusi AO, Bruck R, Ampuero J, Ryder SD, Agarwal K, Fox R, Shaw D, Haider S, Willems B, Lurie Y, Calleja JL, Gane EJ. Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis. J Hepatol. 2019 Oct;71(4):660-665. doi: 10.1016/j.jhep.2019.05.028. Epub 2019 Jun 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003625-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-342-4062
Identifier Type: -
Identifier Source: org_study_id
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