Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination in Participants With Chronic Hepatitis C Virus Infection
NCT ID: NCT02722837
Last Updated: 2018-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
119 participants
INTERVENTIONAL
2016-04-04
2017-09-13
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 FDC tablet administered orally once daily
Interventions
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SOF/VEL
400/100 mg FDC tablet administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
Exclusion Criteria
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Clinical hepatic decompensation
* Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
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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Central Research Institute of Epidemiology
Moscow, , Russia
Central Scientific-Research Institute of Epidemiology
Moscow, , Russia
City Clinical Hospital # 24
Moscow, , Russia
First Moscow Medical University I.M.Sechenov.
Moscow, , Russia
First Moscow State Medical University I.M. Sechenov
Moscow, , Russia
Limited Liability Company "Clinic Tour"
Moscow, , Russia
Scientific Research Institute of Nutrition
Moscow, , Russia
Sklifosovsky Scientific Research Institution of Emergency Care
Moscow, , Russia
Krasnoyarsk Regional Center of AIDS Prevention
Krasnoyarsk, , Russia
Center for Prevention and Control of AIDS and Infectious Diseases
Saint Petersburg, , Russia
Kirov Medical Military Academy
Saint Petersburg, , Russia
North-Western State Medical University named after I.I. Mechnikov
Saint Petersburg, , Russia
LLC Medical Company "Hepatolog"
Samara, , Russia
Sahlgrenska Universitetsjukhuset
Gothenburg, , Sweden
Karolinska University Hospital Huddinge
Stockholm, , Sweden
Countries
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References
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Weiland O, Zhdanov K, Chulanov VP, McNabb BL, Lu S, Svarovskaia EU, et al. Safety and Efficacy of Sofosbuvir/Velpatasvir in a Genotype 1-3 HCV Infected Russian and Swedish Population: Results from a Phase 3, Prospective Trial [Abstract 1186]. Hepatology 2017;66 (1):639A.
Isakov V, Chulanov V, Abdurakhmanov D, Burnevich E, Nurmukhametova E, Kozhevnikova G, Gankina N, Zhuravel S, Romanova S, Hyland RH, Lu S, Svarovskaia ES, McNally J, Brainard DM, Ivashkin V, Morozov V, Bakulin I, Lagging M, Zhdanov K, Weiland O. Sofosbuvir/velpatasvir for the treatment of HCV: excellent results from a phase-3, open-label study in Russia and Sweden. Infect Dis (Lond). 2019 Feb;51(2):131-139. doi: 10.1080/23744235.2018.1535186. Epub 2018 Nov 30.
Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-003001-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-342-1522
Identifier Type: -
Identifier Source: org_study_id
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