Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis
NCT ID: NCT02226549
Last Updated: 2018-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
47 participants
INTERVENTIONAL
2014-07-31
2015-02-28
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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LDV/SOF+VDV
Participants will receive LDV/SOF+VDV for 8 weeks.
LDV/SOF
LDV/SOF (90/400 mg) FDC tablet administered orally once daily
VDV
VDV 80 mg tablet administered orally once daily
LDV/SOF+VDV+RBV
Participants will receive LDV/SOF+VDV+RBV for 8 weeks.
LDV/SOF
LDV/SOF (90/400 mg) FDC tablet administered orally once daily
VDV
VDV 80 mg tablet administered orally once daily
RBV
RBV tablets 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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LDV/SOF
LDV/SOF (90/400 mg) FDC tablet administered orally once daily
VDV
VDV 80 mg tablet administered orally once daily
RBV
RBV tablets 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
* Documentation as treatment-experienced having received pegylated interferon (Peg-IFN) + RBV ≥ 4 weeks of duration without an additional agent in the regimen without achieving sustained viral response (SVR)
* Presence of compensated cirrhosis
* Screening laboratory values within defined thresholds
* Must use specific contraceptive methods if female of childbearing potential or sexually active male
* Not pregnant or a nursing female
Exclusion Criteria
* Current or prior history of clinical hepatic decompensation
* Chronic use of systemic immunosuppressive agents
* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Hyland, DPhil
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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San Antonio, Texas, United States
Countries
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Other Identifiers
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GS-US-337-1512
Identifier Type: -
Identifier Source: org_study_id
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