Ledipasvir/Sofosbuvir Fixed-Dose Combination With Ribavirin or GS-9669 in Subjects With Chronic Genotype 1 HCV Infection
NCT ID: NCT01984294
Last Updated: 2018-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
101 participants
INTERVENTIONAL
2013-10-31
2014-07-31
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+RBV
Participants will receive LDV/SOF plus RBV for 8 weeks.
LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet administered orally once daily
RBV
Ribavirin (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)
LDV/SOF + GS-9669 250 mg
Participants will receive LDV/SOF plus GS-9669 250 mg for 8 weeks.
LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet administered orally once daily
GS-9669
GS-9669 tablet(s) administered orally once daily
LDV/SOF + GS-9669 500 mg
Participants will receive LDV/SOF plus GS-9669 500 mg (2 x 250 mg) for 8 weeks.
LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet administered orally once daily
GS-9669
GS-9669 tablet(s) administered orally once daily
Interventions
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LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet administered orally once daily
RBV
Ribavirin (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)
GS-9669
GS-9669 tablet(s) administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen
* HCV RNA \> 10,000 IU/mL at Screening
* Presence of compensated cirrhosis
* Screening laboratory values within defined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria
* Co-infection with HIV or hepatitis B virus (HBV)
* 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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Rob 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-337-0133
Identifier Type: -
Identifier Source: org_study_id
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