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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF/VEL | Experimental | SOF/VEL FDC for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF/VEL | Drug | SOF/VEL (400/100 mg) FDC tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) | SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. | Posttreatment Week 4 |
| Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital | Chaoyang | Beijing Municipality | 100015 | China | ||
| Nanfang Hospital of Southern Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. | ||
| Result | 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. | ||
| 30555048 | Derived | 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. |
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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.
18 months after study completion
A secured external environment with username, password, and RSA code.
437 participants were screened.
Participants were enrolled at study sites in Asia. The first participant was screened on 19 April 2016. The last study visit occurred on 27 March 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF/VEL | Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Original | Jan 16, 2015 | Nov 29, 2018 |
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SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. |
| 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 | Virologic failure was defined as: (1) On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) or (2) Virologic relapse: confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. | Up to Posttreatment Week 24 |
| 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 City | 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 |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set included participants who were enrolled into the study and received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | SOF/VEL | SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| HCV genotype | Count of Participants | Participants |
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| IL28b Status | Count of Participants | Participants |
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| HCV RNA (log10 international units per milliliter [IU/mL]) | Mean | Standard Deviation | log10 IU/mL |
| ||||||||||||||||||||||
| HCV RNA Category | The CC, CT, and TT alleles are different forms of the IL28b gene. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full Analysis Set included participants who were enrolled into the study and received at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Posttreatment Week 12 |
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| Primary | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | Safety Analysis Set | Posted | Number | Percentage of participants | Up to 12 weeks |
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| Secondary | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) | SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. | Full Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of participants | Posttreatment Week 4 |
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| Secondary | Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) | SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Week 24 |
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| Secondary | Percentage of Participants With HCV RNA < LLOQ On Treatment | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of participants | Weeks 1, 2, 4, 6, 8, 10, and 12 |
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| Secondary | Change From Baseline in HCV RNA | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline and up to Week 12 |
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| Secondary | Percentage of Participants With Overall Virologic Failure | Virologic failure was defined as: (1) On-treatment virologic failure: Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment) or (2) Virologic relapse: confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. | Full Analysis Set | Posted | Number | percentage of participants | Up to Posttreatment Week 24 |
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Up to 12 weeks plus 30 days
Safety Analysis Set included participants who were enrolled into the study and received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SOL/VEL | SOL/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks. | 0 | 375 | 3 | 375 | 36 | 375 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic foot infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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| Ligament rupture | Injury, poisoning and procedural complications | MedDRA (20.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.1) | Systematic Assessment |
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After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 1 | Apr 21, 2015 | Nov 29, 2018 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 18, 2018 | Nov 29, 2018 | SAP_002.pdf |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000611331 | sofosbuvir-velpatasvir drug combination |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| China |
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| Malaysia |
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| Thailand |
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| Genotype 3 |
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| Genotype 6 |
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| Change at Week 2 |
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| Change at Week 4 |
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| Change at Week 6 |
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| Change at Week 8 |
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| Change at Week 10 |
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| Change at Week 12 |
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