Efficacy and Safety of Sofosbuvir/Ledipasvir ± Ribavirin in Japanese Participants With Chronic Genotype 1 HCV Infection
NCT ID: NCT01975675
Last Updated: 2018-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
341 participants
INTERVENTIONAL
2013-10-31
2014-08-31
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 (treatment naive)
Treatment-naive participants will receive LDV/SOF for 12 weeks.
LDV/SOF
LDV/SOF 90/400 mg FDC tablet administered orally once daily
LDV/SOF+RBV (treatment naive)
Treatment-naive participants will receive LDV/SOF plus RBV for 12 weeks.
LDV/SOF
LDV/SOF 90/400 mg FDC tablet administered orally once daily
RBV
RBV tablets 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)
LDV/SOF (treatment experienced)
Treatment-experienced participants will receive LDV/SOF for 12 weeks.
LDV/SOF
LDV/SOF 90/400 mg FDC tablet administered orally once daily
LDV/SOF+RBV (treatment experienced)
Treatment-experienced participants will receive LDV/SOF plus RBV for 12 weeks.
LDV/SOF
LDV/SOF 90/400 mg FDC tablet administered orally once daily
RBV
RBV tablets 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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LDV/SOF
LDV/SOF 90/400 mg FDC tablet administered orally once daily
RBV
RBV tablets 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
* HCV RNA ≥ 10\^5 IU/mL at screening
Exclusion Criteria
* Pregnant or nursing female or male with pregnant female partner
* Chronic liver disease of a non-HCV etiology
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
20 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Steven Knox
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Ichikawa, Chiba, Japan
Kurume, Fukuoka, Japan
Ōgaki, Gifu, Japan
Sapporo, Hokkaido, Japan
Nishinomiya, Hyōgo, Japan
Matsumoto, Nagano, Japan
Ōmura, Nagasaki, Japan
Suita, Osaka, Japan
Izunokuni, Shizuoka, Japan
Chiyoda-ku, Tokyo, Japan
Itabashi-ku, Tokyo, Japan
Musashino, Tokyo, Japan
Shinjuku, Tokyo, Japan
Kofu, Yamanashi, Japan
Akita, , Japan
Chiba, , Japan
Gifu, , Japan
Okayama, , Japan
Yamagata, , Japan
Countries
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References
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Mizokami M, Yokosuka O, Takehara T, Sakamoto N, Korenaga M, Mochizuki H, Nakane K, Enomoto H, Ikeda F, Yanase M, Toyoda H, Genda T, Umemura T, Yatsuhashi H, Ide T, Toda N, Nirei K, Ueno Y, Nishigaki Y, Betular J, Gao B, Ishizaki A, Omote M, Mo H, Garrison K, Pang PS, Knox SJ, Symonds WT, McHutchison JG, Izumi N, Omata M. Ledipasvir and sofosbuvir fixed-dose combination with and without ribavirin for 12 weeks in treatment-naive and previously treated Japanese patients with genotype 1 hepatitis C: an open-label, randomised, phase 3 trial. Lancet Infect Dis. 2015 Jun;15(6):645-53. doi: 10.1016/S1473-3099(15)70099-X. Epub 2015 Apr 8.
Other Identifiers
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GS-US-337-0113
Identifier Type: -
Identifier Source: org_study_id
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