Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis
NCT ID: NCT04112303
Last Updated: 2022-04-20
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
37 participants
INTERVENTIONAL
2019-10-16
2021-06-25
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
Participants received SOF/VEL (400/100 mg) orally once daily for up to 12 weeks.
SOF/VEL
Tablets administered orally once daily
Interventions
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SOF/VEL
Tablets administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment-naïve or treatment-experienced individuals
* Compensated cirrhosis at Screening
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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Chiba University Hospital
Chiba, , Japan
Fukui-ken Saiseikai Hospital
Fukui, , Japan
Japanese Red Cross Fukuoka Hospital
Fukuoka, , Japan
Hiroshima University Hospital Institution Review Board
Hiroshima, , Japan
Iizuka Hospital
Iizuka, , Japan
Nippon Medical School Hospital
Inzai-shi, , Japan
Saitama Medical University Hospital
Iruma, , Japan
Juntendo University Shizuoka Hospital
Izunokuni, , Japan
Nara Medical University Hospital
Kashihara-shi, , Japan
Toranomon Hospital Kajigaya
Kawasaki-shi, , Japan
Kumamoto Shinto General Hospital
Kumamoto, , Japan
Kurme University Hospital
Kurume-shi, , Japan
Matsuyama Red Cross Hospital
Matsuyama, , Japan
Japanese Red Cross Musashino Hospital
Musashino, , Japan
Hyogo College of Medicine Hospital Institutional Review Board
Nishinomiya, , Japan
National Hospital Organization Nagasaki Medical Center
Omura-shi, , Japan
Osaka Red Cross Hospital
Osaka, , Japan
Osaka City University Hospital
Osaka, , Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Sapporo, , Japan
Osaka University Hospital
Suita-shi, , Japan
Kagawa Prefectural Central Hospital
Takamatsu, , Japan
Toranomon Hospital
Tokyo, , Japan
Countries
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References
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Takehara T, Izumi N, Mochida S, Genda T, Fujiyama S, Notsumata K, Tamori A, Suzuki F, Suri V, Mercier RC, Matsuda T, Matsuda K, Kato N, Chayama K, Kumada H. Sofosbuvir-velpatasvir in adults with hepatitis C virus infection and compensated cirrhosis in Japan. Hepatol Res. 2022 Oct;52(10):833-840. doi: 10.1111/hepr.13810. Epub 2022 Aug 8.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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JapicCTI-194989
Identifier Type: REGISTRY
Identifier Source: secondary_id
GS-US-342-5531
Identifier Type: -
Identifier Source: org_study_id
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