Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV
A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV
1 other identifier
interventional
375
5 countries
38
Brief Summary
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2016
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 29, 2016
CompletedFirst Posted
Study publicly available on registry
February 2, 2016
CompletedStudy Start
First participant enrolled
April 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2018
CompletedResults Posted
Study results publicly available
January 8, 2019
CompletedJanuary 8, 2019
December 1, 2018
1.7 years
January 29, 2016
December 20, 2018
December 20, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Up to 12 weeks
Secondary Outcomes (5)
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
Posttreatment Week 4
Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
Posttreatment Week 24
Percentage of Participants With HCV RNA < LLOQ On Treatment
Weeks 1, 2, 4, 6, 8, 10, and 12
Change From Baseline in HCV RNA
Baseline and up to Week 12
Percentage of Participants With Overall Virologic Failure
Up to Posttreatment Week 24
Study Arms (1)
SOF/VEL
EXPERIMENTALSOF/VEL FDC for 12 weeks
Interventions
SOF/VEL (400/100 mg) FDC tablet administered orally once daily
Eligibility Criteria
You may qualify if:
- Willing and able to provide written informed consent
- 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)
You may not qualify if:
- Current or prior history of clinically-significant illness (other than HCV), gastrointestinal disorder, clinical hepatic decompensation, or post-operative condition that could interfere with the absorption of the study drug
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (38)
Beijing Ditan Hospital
Chaoyang, Beijing Municipality, 100015, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510630, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Tongji Hospital Affiliated to Tongji Medicine University
Wuhan, Hubei, 430030, China
Xiangyan Hospital, Central South University
Changsha, Hunan, 410008, China
Shanghai Public Health Clinical Center
Hongkou, Shanghai Municipality, 200083, China
Shanghai Ruijin Hospital
Huangpu, Shanghai Municipality, 200025, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Peking University First Hospital
Beijing, 100034, China
Peking University People's Hospital
Beijing, 100044, China
Beijing Friendship Hospital Affiliate of Capital Medical University
Beijing, 100050, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, 400010, China
Guangzhou Eighth People's Hospital
Guangdong, 510060, China
The People's Hospital of Hainan Province
Hainan, 570311, China
The 2nd Xiangya Hospital of Central South University
Hunan, 410011, China
The Second Hospital of Nanjing
Jiangsu, 210003, China
The First Hospital of Jilin University
Jilin, 130021, China
Jinan Infectious Disease Hospital
Jinan, 250000, China
Shengjing Hospital of China Medical University
Liaoning, 110004, China
The First Affiliated Hospital of NanChang University
Nanchang, 330006, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, 200001, China
Shanghai Renji Hospital
Shanghai, 200001, China
The 3rd Hospital of Hebei Medical University
Shijiazhuang, 050051, China
Henan Province People's Hospital
Zhengzhou, 450016, China
University of Malaya
Kuala Lumpur, 59100, Malaysia
Hospital Tengku Ampuan Afzan
Kuala Pahang, 25100, Malaysia
National University Hospital
Singapore, 119074, Singapore
Singapore General Hospital
Singapore, 169608, Singapore
Chulalongkorn Hospital
Bangkok, 10330, Thailand
Ramathibodi Hospital Mahidol University
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Maharaj Nakhon Chiangmai Hospital
Chiang Mai, 50202, Thailand
Songklanagarind Hospital
Songkhla, 90110, Thailand
Bach Mai Hospital
Hanoi, 100000, Vietnam
National Hospital for Tropical Disease
Hanoi, 100000, Vietnam
Ho Chi Minh City Hospital for Tropical Diseasees
Ho Chi Minh City, 700000, Vietnam
People's Hospital 115
Ho Chi Minh City, 700000, Vietnam
Related Publications (3)
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.
RESULTWei 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.
RESULTWei 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.
PMID: 30555048DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 29, 2016
First Posted
February 2, 2016
Study Start
April 19, 2016
Primary Completion
January 5, 2018
Study Completion
March 27, 2018
Last Updated
January 8, 2019
Results First Posted
January 8, 2019
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 18 months after study completion
- Access Criteria
- A secured external environment with username, password, and RSA code.
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.