Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV
NCT ID: NCT02671500
Last Updated: 2019-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
375 participants
INTERVENTIONAL
2016-04-19
2018-03-27
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
SOF/VEL FDC for 12 weeks
SOF/VEL
SOF/VEL (400/100 mg) FDC tablet administered orally once daily
Interventions
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SOF/VEL
SOF/VEL (400/100 mg) FDC tablet administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCV RNA ≥ 10\^4 IU/mL at screening
* Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
* Any HCV genotype (1, 2, 3, 4, 5, 6 or indeterminate)
* HCV treatment-naive or treatment-experienced
* Liver imaging within 6 months of Day 1 is required in cirrhotic patients only to exclude hepatocellular carcinoma (HCC)
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)
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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Beijing Ditan Hospital
Chaoyang, Beijing Municipality, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Tongji Hospital Affiliated to Tongji Medicine University
Wuhan, Hubei, China
Xiangyan Hospital, Central South University
Changsha, Hunan, China
Shanghai Public Health Clinical Center
Hongkou, Shanghai Municipality, China
Shanghai Ruijin Hospital
Huangpu, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Peking University First Hospital
Beijing, , China
Peking University People's Hospital
Beijing, , China
Beijing Friendship Hospital Affiliate of Capital Medical University
Beijing, , China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, , China
Guangzhou Eighth People's Hospital
Guangdong, , China
The People's Hospital of Hainan Province
Hainan, , China
The 2nd Xiangya Hospital of Central South University
Hunan, , China
The Second Hospital of Nanjing
Jiangsu, , China
The First Hospital of Jilin University
Jilin, , China
Jinan Infectious Disease Hospital
Jinan, , China
Shengjing Hospital of China Medical University
Liaoning, , China
The First Affiliated Hospital of NanChang University
Nanchang, , China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Shanghai Renji Hospital
Shanghai, , China
The 3rd Hospital of Hebei Medical University
Shijiazhuang, , China
Henan Province People's Hospital
Zhengzhou, , China
University of Malaya
Kuala Lumpur, , Malaysia
Hospital Tengku Ampuan Afzan
Kuala Pahang, , Malaysia
National University Hospital
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Chulalongkorn Hospital
Bangkok, , Thailand
Ramathibodi Hospital Mahidol University
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Maharaj Nakhon Chiangmai Hospital
Chiang Mai, , Thailand
Songklanagarind Hospital
Songkhla, , Thailand
Bach Mai Hospital
Hanoi, , Vietnam
National Hospital for Tropical Disease
Hanoi, , Vietnam
Ho Chi Minh City Hospital for Tropical Diseasees
Ho Chi Minh City, , Vietnam
People's Hospital 115
Ho Chi Minh City, , Vietnam
Countries
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References
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Lim SG, Rosmawati M, Phuong L, Hoi PT, McNabb BL, Lu S, et al. Safety and Efficacy of Sofosbuvir/Velpatasvir in a Genotype 1-6 HCV Infected Population from Singapore, Malaysia, Thailand, and Vietnam: Results from a Phase 3, Clinical Trial [Abstract 1094]. Hepatology 2017; 66 (1 Suppl): 586A.
Wei L, Xie Q, Huang Y, Wu S, Xu M, Tang H, et al. Safety and Efficacy of Sofosbuvir/Velpatasvir in Genotype 1-6 HCV-Infected Patients in China: Results from a Phase 3 Clinical Trial. [Abstract 637]. Hepatology 2018; 68 (1 Suppl): 379A.
Wei L, Lim SG, Xie Q, Van KN, Piratvisuth T, Huang Y, Wu S, Xu M, Tang H, Cheng J, Le Manh H, Gao Y, Mou Z, Sobhonslidsuk A, Dou X, Thongsawat S, Nan Y, Tan CK, Ning Q, Tee HP, Mao Y, Stamm LM, Lu S, Dvory-Sobol H, Mo H, Brainard DM, Yang YF, Dao L, Wang GQ, Tanwandee T, Hu P, Tangkijvanich P, Zhang L, Gao ZL, Lin F, Le TTP, Shang J, Gong G, Li J, Su M, Duan Z, Mohamed R, Hou JL, Jia J. Sofosbuvir-velpatasvir for treatment of chronic hepatitis C virus infection in Asia: a single-arm, open-label, phase 3 trial. Lancet Gastroenterol Hepatol. 2019 Feb;4(2):127-134. doi: 10.1016/S2468-1253(18)30343-1. Epub 2018 Dec 14.
Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Statistical Analysis Plan
Other Identifiers
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GS-US-342-1518
Identifier Type: -
Identifier Source: org_study_id
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