Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis
NCT ID: NCT02996682
Last Updated: 2019-02-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
102 participants
INTERVENTIONAL
2016-12-26
2018-05-08
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
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
SOF/VEL + RBV
SOF/VEL + RBV for 12 weeks
SOF/VEL
400/100 mg FDC tablet administered orally once daily
RBV
Capsules administered orally in a divided daily dose
Interventions
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SOF/VEL
400/100 mg FDC tablet administered orally once daily
RBV
Capsules administered orally in a divided daily dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment naive or treatment experienced individuals
* Child-Pugh-Turcotte Score 7-12 at screening
20 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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Shimonoseki, Yamaguchi, Japan
Bunkyō City, , Japan
Chiba, , Japan
Chūō, , Japan
Ehime, , Japan
Fukui, , Japan
Fukuyama-shi, , Japan
Hiroshima, , Japan
Ibaraki, , Japan
Ichikawa, , Japan
Iizuka, , Japan
Iruma, , Japan
Izunokuni, , Japan
Kashibara, , Japan
Kofu, , Japan
Kumamoto, , Japan
Kurume, , Japan
Kyoto, , Japan
Miyazaki, , Japan
Morioka, , Japan
Musashino, , Japan
Nagoya, , Japan
Nishinomiya, , Japan
Okayama, , Japan
Osaka, , Japan
Ōmura, , Japan
Sapporo, , Japan
Sendai, , Japan
Shimotsuga-gun, , Japan
Suita, , Japan
Takamatsu, , Japan
Ube, , Japan
Yamagata, , Japan
Countries
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References
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Takehara T, Kurosaki M, Tanaka Y, Tatsumi T, Ikeda F, Takikawa Y, et al. Sofosbuvir/Velpatasvir with or without Ribavirin for 12 Weeks in HCV-Infected Japanese Subjects with Decompensated Cirrhosis [Presentation]. 54th Annual Meeting of Japan Society of Hepatology; 2018 June 15; Osaka, Japan.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GS-US-342-4019
Identifier Type: -
Identifier Source: org_study_id
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