Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection
NCT ID: NCT02021656
Last Updated: 2020-03-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
384 participants
INTERVENTIONAL
2013-12-10
2017-09-29
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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LDV/SOF
Treatment-experienced and treatment-naive participants will receive LDV/SOF for 12 weeks.
LDV/SOF
90/400 mg FDC tablet administered orally once daily without regard to food
Interventions
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LDV/SOF
90/400 mg FDC tablet administered orally once daily without regard to food
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCV RNA ≥ 10\^4 IU/mL at screening
* HCV treatment-naive, as defined as no prior exposure to any interferon (IFN) or other approved or experimental HCV-specific direct-acting antiviral agent; OR HCV treatment-experienced with medical records that include sufficient detail of prior IFN-based treatment to allow for categorization of prior response as either intolerant, non-responder, or experienced viral breakthrough or relapse.
* Genotype 1 HCV at screening
* HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy
Exclusion Criteria
* Chronic liver disease of a non-HCV etiology
* Current or prior history of any clinically-significant illness (other than HCV)
* 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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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Beijing, , China
Chongqing, , China
Guangdong, , China
Guangxi, , China
Hubei, , China
Hunan, , China
Jiangxi, , China
Jiangxi, , China
Jilin, , China
Shandong, , China
Shanghai, , China
Shanghai, , China
Shijiazhuang, , China
Sichuan, , China
Ansan-si, Gyeonggi-do, South Korea
Bucheon-si, Gyeonggi-do, South Korea
Incheon, Gyeonggi-do, South Korea
Seongnam-si, Gyeonggi-do, South Korea
Busan, , South Korea
Busan, , South Korea
Busan, , South Korea
Daegu, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Changhua, , Taiwan
Kaohsiung City, , Taiwan
Kaohsiung City, , Taiwan
Kaohsiung City, , Taiwan
Keelung, , Taiwan
Taichung, , Taiwan
Tainan City, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Countries
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References
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Wei L, Xie Q, Hou JL, et al. Safety and Efficacy of Ledipasvir/Sofosbuvir in a Genotype 1 HCV Infected Chinese Population: Results from a Phase 3 Clinical Trial. Poster No. 1191, AASLD 2017.
Lim YS, Ahn SH, Lee KS, Paik SW, Lee YJ, Jeong SH, Kim JH, Yoon SK, Yim HJ, Tak WY, Han SY, Yang JC, Mo H, Garrison KL, Gao B, Knox SJ, Pang PS, Kim YJ, Byun KS, Kim YS, Heo J, Han KH. A phase IIIb study of ledipasvir/sofosbuvir fixed-dose combination tablet in treatment-naive and treatment-experienced Korean patients chronically infected with genotype 1 hepatitis C virus. Hepatol Int. 2016 Nov;10(6):947-955. doi: 10.1007/s12072-016-9726-5. Epub 2016 May 20.
Chuang WL, Chien RN, Peng CY, Chang TT, Lo GH, Sheen IS, Wang HY, Chen JJ, Yang JC, Knox SJ, Gao B, Garrison KL, Mo H, Pang PS, Hsu YC, Hu TH, Chu CJ, Kao JH. Ledipasvir/sofosbuvir fixed-dose combination tablet in Taiwanese patients with chronic genotype 1 hepatitis C virus. J Gastroenterol Hepatol. 2016 Jul;31(7):1323-9. doi: 10.1111/jgh.13305.
Wei L, Xie Q, Hou JL, et al. Safety and Efficacy of Ledipasvir/Sofosbuvir in a Genotype 1 HCV Infected Chinese Population: Results from a Phase 3 Clinical Trial., [Abstract 1191]. The Liver Meeting® 2017 - The 68th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2017 20-24 October; Washington, D. C.
Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 2
Document Type: Study Protocol: Amendment 3
Document Type: Statistical Analysis Plan
Other Identifiers
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GS-US-337-0131
Identifier Type: -
Identifier Source: org_study_id
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