Clinical trial NCT02671500: Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus Infection
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2016-02-02
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* 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)

Key Exclusion Criteria:

* 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)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
timeFrame: Posttreatment Week 12
measure: Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
timeFrame: Posttreatment Week 4
measure: Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
timeFrame: Posttreatment Week 24
measure: Percentage of Participants With HCV RNA < LLOQ On Treatment
timeFrame: Weeks 1, 2, 4, 6, 8, 10, and 12
measure: Change From Baseline in HCV RNA
timeFrame: Baseline and up to Week 12
measure: Percentage of Participants With Overall Virologic Failure
timeFrame: Up to Posttreatment Week 24
Other outcomes:
Locations:
city: Chaoyang
country: China
facility: Beijing Ditan Hospital
state: Beijing
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medicine University
state: Hubei
city: Changsha
country: China
facility: Xiangyan Hospital, Central South University
state: Hunan
city: Hongkou
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
city: Huangpu
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Beijing Friendship Hospital Affiliate of Capital Medical University
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
city: Guangdong
country: China
facility: Guangzhou Eighth People's Hospital
city: Hainan
country: China
facility: The People's Hospital of Hainan Province
city: Hunan
country: China
facility: The 2nd Xiangya Hospital of Central South University
city: Jiangsu
country: China
facility: The Second Hospital of Nanjing
city: Jilin
country: China
facility: The First Hospital of Jilin University
city: Jinan
country: China
facility: Jinan Infectious Disease Hospital
city: Liaoning
country: China
facility: Shengjing Hospital of China Medical University
city: Nanchang
country: China
facility: The First Affiliated Hospital of NanChang University
city: Shanghai
country: China
facility: Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Shanghai Renji Hospital
city: Shijiazhuang
country: China
facility: The 3rd Hospital of Hebei Medical University
city: Zhengzhou
country: China
facility: Henan Province People's Hospital
city: Kuala Lumpur
country: Malaysia
facility: University of Malaya
city: Pahang
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Bangkok
country: Thailand
facility: Chulalongkorn Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital Mahidol University
city: Bankok
country: Thailand
facility: Siriraj Hospital
city: Chiang Mai
country: Thailand
facility: Maharaj Nakhon Chiangmai Hospital
city: Songkla
country: Thailand
facility: Songklanagarind Hospital
city: Hanoi
country: Vietnam
facility: Bach Mai Hospital
city: Hanoi
country: Vietnam
facility: National Hospital for Tropical Disease
city: Ho Chi Minh City
country: Vietnam
facility: People's Hospital 115
city: Ho Chi Minh
country: Vietnam
facility: Ho Chi Minh City Hospital for Tropical Diseasees
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.