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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003898-42 | EudraCT Number |
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The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1, 2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study GS-US-342-1138.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF/VEL | Experimental | SOF/VEL for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF/VEL | Drug | 400/100 mg tablet administered orally once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. | 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 Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. | Posttreatment Weeks 4 and 24 |
| Percentage of Participants With HCV RNA < LLOQ While on Treatment |
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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 |
|---|---|---|---|---|---|---|
| Long Beach | California | 90822 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Asselah T, Shafran S, Bourgeois S, Lai CL, Cramp M, Mathurin P, et al. Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in HCV Infected Patients Previously Treated With Placebo: Results of the Deferred Treatment Study (GS-US-342-1446 Study) [Abstract SAT-279]. J Hepatology 2016;64:S827-8. | ||
| 31216086 | Derived | Asselah T, Shafran SD, Bourgeois S, Lai CL, Mathurin P, Willems B, Nguyen MH, Davis MN, Huang KC, Svarovskaia E, Osinusi A, McNally J, Brainard DM, Shaikh OS, Tran TT. Deferred treatment with a fixed-dose combination of sofosbuvir-velpatasvir for chronic hepatitis C virus genotype 1, 2, 4 and 6 infection. J Viral Hepat. 2019 Oct;26(10):1229-1232. doi: 10.1111/jvh.13159. Epub 2019 Aug 4. |
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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.
116 participants were screened.
Participants were enrolled at study sites in North America, Europe, and Asia Pacific. The first participant was screened on 23 February 2015. The last study visit occurred on 15 June 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF/VEL 12 Weeks | Sofosbuvir/velpatasvir (SOF/VEL; Epclusa®) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline to Week 12 |
| HCV RNA Change From Baseline | Baseline to Week 12 |
| Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| Up to Posttreatment Week 24 |
| Los Angeles |
| California |
| 90027 |
| United States |
| Los Angeles | California | 90036 | United States |
| Los Angeles | California | 90048 | United States |
| Palo Alto | California | 94304 | United States |
| Sacramento | California | 95817 | United States |
| San Diego | California | 92123 | United States |
| San Diego | California | 92154 | United States |
| Aurora | Colorado | 80045 | United States |
| Gainesville | Florida | 32610-0272 | United States |
| Jacksonville | Florida | 32256 | United States |
| Miami | Florida | 33136 | United States |
| Wellington | Florida | 33414 | United States |
| Atlanta | Georgia | 30308 | United States |
| Marietta | Georgia | 30066 | United States |
| Indianapolis | Indiana | 46237 | United States |
| Baltimore | Maryland | 21202 | United States |
| Boston | Massachusetts | 02129 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Pittsburgh | Pennsylvania | 15240 | United States |
| Providence | Rhode Island | 02905 | United States |
| Germantown | Tennessee | 38138 | United States |
| Nashville | Tennessee | 37211 | United States |
| Richmond | Virginia | 23226 | United States |
| Antwerp | 2060 | Belgium |
| Brussels | 1070 | Belgium |
| Edmonton | Alberta | T6G 2B7 | Canada |
| Vancouver | British Columbia | V5Z 1M9 | Canada |
| Vancouver | British Columbia | V6Z2C7 | Canada |
| Montreal | Quebec | H2X 0A9 | Canada |
| Toronto | M5T 2S8 | Canada |
| Clermont-Ferrand | 63000 | France |
| Clichy | 92110 | France |
| Créteil | 94000 | France |
| Lille | 59037 | France |
| Limoges | 87042 | France |
| Lyon | 69004 | France |
| Marseille | 13008 | France |
| Paris | 75014 | France |
| Pessac | 33604 | France |
| Toulouse | 31059 | France |
| Villejuif | 94804 | France |
| Cologne | North Rhine-Westphalia | 50932 | Germany |
| Düsseldorf | North Rhine-Westphalia | 40237 | Germany |
| Berlin | D-10969 | Germany |
| Hamburg | 20099 | Germany |
| Hanover | 30625 | Germany |
| München | 81377 | Germany |
| Hong Kong | Hong Kong |
| San Giovanni Rotondo | Foggia | 71013 | Italy |
| Florence | 50012 | Italy |
| San Juan | 09027 | Puerto Rico |
| Plymouth | Devon | PL6 8DH | United Kingdom |
| Portsmouth | Hampshire | PO6 3LY | United Kingdom |
| Glasgow | G12 0YN | United Kingdom |
| London | E1 4AT | United Kingdom |
| London | NW3 2PF | United Kingdom |
| London | W2 1NY | United Kingdom |
| Manchester | M8 5RB | United Kingdom |
| Oxford | OX3 9DU | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set included participants who took at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | SOF/VEL 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| IL28b Status | The CC, CT, and TT alleles are different forms of the IL28b gene. | Count of Participants | Participants |
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| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
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| HCV RNA Category | 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 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. | Full Analysis Set (FAS) included all enrolled participants who took 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 Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Weeks 4 and 24 |
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| Secondary | Percentage of Participants With HCV RNA < LLOQ While on Treatment | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Week 12 |
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| Secondary | HCV RNA Change From Baseline | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline to Week 12 |
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| Secondary | Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| 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
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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 | SOF/VEL 12 Weeks | SOF/VEL (400/100 mg) FDC tablet orally once daily | 5 | 111 | 46 | 111 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Lymphangitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Gallbladder adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
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| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | 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 | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D005355 | Fibrosis |
| 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000611331 | sofosbuvir-velpatasvir drug combination |
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| Asian |
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| Native Hawaiian or Pacific Islander |
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| Other |
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| United States |
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| China |
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| United Kingdom |
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| Italy |
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| France |
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| Germany |
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| Hong Kong |
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| Puerto Rico |
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| TT |
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| Title | Denominators | Categories | ||||
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| SVR4 |
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| SVR24 |
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| Week 12 |
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| Change at Week 1 |
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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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