Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study
NCT ID: NCT02300103
Last Updated: 2018-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
69 participants
INTERVENTIONAL
2014-12-01
2016-09-15
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+RBV
Participants will receive SOF/VEL fixed dose combination (FDC) and RBV for 24 weeks.
SOF/VEL
400/100 mg FDC tablet administered orally once daily
RBV
Tablet (s) administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Interventions
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SOF/VEL
400/100 mg FDC tablet administered orally once daily
RBV
Tablet (s) administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCV genotype determined by the Central Laboratory
* HCV RNA \> LLOQ at screening
* Participated and completed a Gilead sponsored HCV treatment study of direct acting antiviral (DAA) containing regimens.
* Male and female of childbearing potential must agree to use protocol specified method(s) of contraception
Exclusion Criteria
* Screening ECG with clinically significant abnormalities
* Laboratory results outside of acceptable ranges at screening
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
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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San Diego, California, United States
San Marcos, California, United States
Aurora, Colorado, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Wellington, Florida, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Hillsborough, New Jersey, United States
Manhasset, New York, United States
Durham, North Carolina, United States
Fayetteville, North Carolina, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Germantown, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Falls Church, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Darlinghurst, New South Wales, Australia
Fitzroy, Victoria, Australia
Melbourne, Victoria, Australia
Murdoch, Western Australia, Australia
Auckland, , New Zealand
Christchurch, , New Zealand
San Juan, , Puerto Rico
Countries
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References
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Gane EJ, Shiffman ML, Etzkorn K, Morelli G, Stedman C, Davis MN, et al. Sofosbuvir/Velpatasvir in Combination With Ribavirin for 24 Weeks is Effective Retreatment for Patients Who Failed Prior NS5A Containing DAA Regimens: Results of the GS-US-342-1553 Study [Abstract PS024]. J Hepatology 2016;64:S147-S8.
Other Identifiers
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GS-US-342-1553
Identifier Type: -
Identifier Source: org_study_id
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