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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001683-35 | EudraCT Number |
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The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF/VEL | Experimental | SOF/VEL for 12 weeks |
|
| Placebo | Placebo Comparator | SOF/VEL placebo for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF/VEL | Drug | 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 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. | Posttreatment Weeks 4 and 24 |
| Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John McNally, PhD | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Asselah T, Charlton M, Feld J, Foster GR, Mcnally J, Brainard DM, et al. The ASTRAL Studies: Evaluation of SOF/GS-5816 Single Tablet Regimen for the Treatment of Genotype 1-6 HCV Infection [Poster P1332]. J Hepatol 2015;62:S855-S6. | ||
| 26571066 | Result | Feld JJ, Jacobson IM, Hezode C, Asselah T, Ruane PJ, Gruener N, Abergel A, Mangia A, Lai CL, Chan HL, Mazzotta F, Moreno C, Yoshida E, Shafran SD, Towner WJ, Tran TT, McNally J, Osinusi A, Svarovskaia E, Zhu Y, Brainard DM, McHutchison JG, Agarwal K, Zeuzem S; ASTRAL-1 Investigators. Sofosbuvir and Velpatasvir for HCV Genotype 1, 2, 4, 5, and 6 Infection. N Engl J Med. 2015 Dec 31;373(27):2599-607. doi: 10.1056/NEJMoa1512610. Epub 2015 Nov 16. | |
| Result | Feld JJ, Agarwal K, Hezode C, Asselah T, Ruane PJ, Gruener N, et al. A Phase 3 Double-Blind Placebo-Controlled Evaluation of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Naive and Experienced Genotype 1, 2, 4, 5, 6 HCV Infected Patients with and without Cirrhosis: Results of the ASTRAL-1 Study. J Hepatol 2015;62(6) Suppl:1379A-1380A. |
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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.
847 participants were screened.
Participants were enrolled at study sites in the United States, Canada, Europe, and Asia. The first participant was screened on 18 July 2014. The last study visit occurred on 23 September 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF/VEL | Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks |
| FG001 | Placebo | SOF/VEL placebo tablet administered orally once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Placebo | Drug | Tablet administered orally once daily |
|
| Weeks 1, 2, 4, 6, 8, 10, and 12 |
| Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12 | Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12 |
| Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| Up to Posttreatment Week 24 |
| Long Beach |
| California |
| United States |
| Los Angeles | California | 90027 | United States |
| Los Angeles | California | 90036 | United States |
| Los Angeles | California | 90048 | United States |
| Palo Alto | California | United States |
| Sacramento | California | 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 | United States |
| Miami | Florida | United States |
| Orlando | Florida | United States |
| Wellington | Florida | United States |
| Atlanta | Georgia | 30308 | United States |
| Marietta | Georgia | United States |
| Chicago | Illinois | 60611 | United States |
| Indianapolis | Indiana | 46237 | United States |
| Baltimore | Maryland | United States |
| Lutherville | Maryland | 21093 | United States |
| Boston | Massachusetts | 02215 | United States |
| Detroit | Michigan | 48188 | United States |
| New York | New York | 10021 | United States |
| The Bronx | New York | 10468 | 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 | United States |
| Nashville | Tennessee | United States |
| San Antonio | Texas | 78215 | United States |
| Norfolk | Virginia | United States |
| Richmond | Virginia | United States |
| Antwerp | 2060 | Belgium |
| Brussels | 1070 | Belgium |
| Kortrijk | 8500 | Belgium |
| Calgary | Alberta | T2N 4Z6 | Canada |
| Edmonton | Alberta | T6G 2B7 | Canada |
| Vancouver | British Columbia | V5Z 1M9 | Canada |
| Vancouver | British Columbia | V6Z2C7 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Montreal | Quebec | H2X 0A9 | Canada |
| Toronto | M5T 2S8 | Canada |
| Hong Kong | China |
| 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 |
| Frankfurt am Main | Hessin | 60590 | Germany |
| Cologne | North Rhine-Westphalia | 50932 | Germany |
| Düsseldorf | North Rhine-Westphalia | 40237 | Germany |
| Hufelandstr | North Rhine-Westphalia | 45122 | Germany |
| Berlin | 12157 | Germany |
| Berlin | D-10969 | Germany |
| Hamburg | 20099 | Germany |
| Hanover | 30625 | Germany |
| München | 81377 | Germany |
| San Giovanni Rotondo | Foggia | 71013 | Italy |
| San Giovanni Rotondo | Foggia | Italy |
| Florence | 50012 | Italy |
| San Juan | 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 | SE5 9RS | United Kingdom |
| London | SW170QT | United Kingdom |
| London | W2 1NY | United Kingdom |
| Manchester | M8 5RB | United Kingdom |
| Nottingham | NG7 2UH | United Kingdom |
| Oxford | OX3 9DU | United Kingdom |
| 36740893 | Derived | Jacobson IM, Bourgeois S, Mathurin P, Thuluvath P, Ryder SD, Gerken G, Hernandez C, Vanstraelen K, Scherbakovsky S, Osinusi A, Tedesco D, Foster GR. The tolerability of sofosbuvir/velpatasvir for 12 weeks in patients treated in the ASTRAL 1, 2 and 3 studies: A pooled safety analysis. J Viral Hepat. 2023 May;30(5):448-454. doi: 10.1111/jvh.13814. Epub 2023 Mar 2. |
| 27847279 | Derived | Younossi ZM, Stepanova M, Feld J, Zeuzem S, Sulkowski M, Foster GR, Mangia A, Charlton M, O'Leary JG, Curry MP, Nader F, Henry L, Hunt S. Sofosbuvir and Velpatasvir Combination Improves Patient-reported Outcomes for Patients With HCV Infection, Without or With Compensated or Decompensated Cirrhosis. Clin Gastroenterol Hepatol. 2017 Mar;15(3):421-430.e6. doi: 10.1016/j.cgh.2016.10.037. Epub 2016 Nov 12. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set: participants who 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 administered orally once daily for 12 weeks |
| BG001 | Placebo | SOF/VEL placebo tablet administered orally once daily for 12 weeks |
| BG002 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | All randomized participants were analyzed for Region of Enrollment (N = 741). | Number | participants |
| |||||||||||||||
| Cirrhosis Status | Number | participants |
| ||||||||||||||||
| HCV Genotype | Number | participants |
| ||||||||||||||||
| IL28b Status | CC, CT, and TT alleles are different forms of the IL28b gene. | Number | participants |
| |||||||||||||||
| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| HCV RNA Category | Number | participants |
|
| 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: participants randomized or 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 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively. | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Weeks 4 and 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12 | 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 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
|
|
Up to 12 weeks plus 30 days
Safety Analysis Set
Not provided
| 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 | SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks | 15 | 624 | 393 | 624 | ||
| EG001 | Placebo | SOF/VEL placebo tablet administered orally once daily for 12 weeks | 0 | 116 | 77 | 116 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 18 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 18 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA Version 18 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA Version 18 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA Version 18 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA Version 18 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 18 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 18 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 18 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 18 | Systematic Assessment |
| |
| Vestibular neuronitis | Infections and infestations | MedDRA Version 18 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA Version 18 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA Version 18 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 18 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 18 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA Version 18 | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA Version 18 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18 | Systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA Version 18 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 18 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 18 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 18 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 18 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 18 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 18 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 18 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 18 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 18 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 18 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18 | Systematic Assessment |
|
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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000611331 | sofosbuvir-velpatasvir drug combination |
Not provided
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Asian |
|
| American Indian/ Alaska Native |
|
| Hawaiian or Pacific Islander |
|
| Other |
|
| Not Disclosed |
|
| Belgium |
|
| United States |
|
| China |
|
| Italy |
|
| United Kingdom |
|
| France |
|
| Germany |
|
| Absent |
|
| Missing |
|
| Genotype 2 |
|
| Genotype 4 |
|
| Genotype 5 |
|
| Genotype 6 |
|
| CT |
|
| TT |
|
| Missing |
|
| ≥ 800,000 IU/mL |
|
|
|
|
|
|