Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
NCT ID: NCT02822794
Last Updated: 2018-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
117 participants
INTERVENTIONAL
2016-07-25
2017-08-25
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 FDC + RBV 12 weeks
SOF/VEL FDC + RBV for 12 weeks in participants with genotype 1 or 2 HCV infection
SOF/VEL
400/100 mg tablet administered orally once daily
RBV
Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, \> 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)
SOF/VEL FDC + RBV 24 weeks
SOF/VEL FDC + RBV for 24 weeks in participants with genotype 1 or 2 HCV infection
SOF/VEL
400/100 mg tablet administered orally once daily
RBV
Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, \> 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)
Interventions
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SOF/VEL
400/100 mg tablet administered orally once daily
RBV
Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, \> 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic HCV infection (≥ 6 months prior to screening) documented by prior medical history or liver biopsy
* Previously treated with a DAA-containing regimen of at least 4 week duration
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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Ehime, , Japan
Hiroshima, , Japan
Ichikawa-shi, , Japan
Iruma-gun, , Japan
Kashihara, , Japan
Kurume-shi, , Japan
Kyoto, , Japan
Maebashi, , Japan
Musashino-shi, , Japan
Nagoya, , Japan
Nishinomiya, , Japan
Okayama, , Japan
Ōgaki, , Japan
Ōmura, , Japan
Sapporo, , Japan
Suita, , Japan
Takamatsu, , Japan
Yamagata, , Japan
Countries
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Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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GS-US-342-3921
Identifier Type: -
Identifier Source: org_study_id
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