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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000179-98 | EudraCT Number |
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The primary objectives of this study are to determine the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection with or without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral (DAA)-containing regimens.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF/VEL/VOX | Experimental | SOF/VEL/VOX for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF/VEL/VOX | Drug | 400/100/100 mg FDC tablet administered orally once daily with food |
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| 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 Week 12 |
| 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 HCV RNA < LLOQ On Treatment |
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Key Inclusion 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 |
|---|---|---|---|---|---|---|
| Ruane Clinical Research Group Inc. | Los Angeles | California | 90036 | United States | ||
| Cedars Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Ruane P, Strasser SJ, Gane EJ, Hyland RH, Shao J, Dvory-Sobol H, et al. Retreatment with Sofosbuvir/Velpatasvir/Voxilaprevir for 12 weeks is safe and effective for patients who have previously received Sofosbuvir/Velpatasvir or Sofosbuvir/Velpatasvir/Voxilaprevir [Abstract LBO-06]. 16th International Symposium on Viral Hepatitis and Liver Diseases (ISVHLD); 2018 14-17 June; Toronto, Canada |
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Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/about/ethics-and-code-of-conduct/policies.
18 months after study completion
A secured external environment with username, password, and RSA code.
38 participants were screened.
Participants were enrolled at study sites in North America, Europe, New Zealand, and Australia. The first participant was screened on 25 April 2017. The last study visit occurred on 19 March 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF/VEL/VOX | Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) (400/100/100 mg) fixed-dose combination (FDC) tablet 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 | Jan 19, 2017 | Feb 6, 2019 |
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| Weeks 2, 4, 8, and 12 |
| Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| Up to Posttreatment Week 12 |
| Change From Baseline in HCV RNA | Baseline; Weeks 2, 4, 8, and 12 |
| Los Angeles |
| California |
| 90048 |
| United States |
| Stanford Hospital and Clinics | Palo Alto | California | 94304 | United States |
| Inland Empire Liver Foundation | Rialto | California | 92377 | United States |
| Kaiser Permanente | San Diego | California | 92154 | United States |
| University of Colorado Denver (Leprino Building) | Aurora | Colorado | 80045 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Emory Hospital Midtown Infectious Disease Clinic | Atlanta | Georgia | 30308 | United States |
| Gastrointestinal Specialists of Georgia | Marietta | Georgia | 30060 | United States |
| Saint Louis University, Gastroenterology & Hepatology, Clinical Research Unit | St Louis | Missouri | 63104 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| Columbia University Medical Center/ New York Presbyterian | New York | New York | 10032 | United States |
| Center for Liver Diseases, Oakland | Pittsburgh | Pennsylvania | 15213 | United States |
| University Gastroenterology | Providence | Rhode Island | 02905 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| New Orleans Center for Clinical Research | Knoxville | Tennessee | 37920 | United States |
| University of Washington/Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Translational Research Centre | Darlinghurst | New South Wales | 2010 | Australia |
| Kay Edmonton Clinic | Edmonton | T6G IZI | Canada |
| Toronto Centre for Liver Disease (TCLD), Toronto General Hospital | Toronto | M5G 2C4 | Canada |
| Centre Hospitalier Universitaire de Rouen | Rouen | 76031 | France |
| Leber- and Studienzentrum am Checkpoint | Berlin | 10969 | Germany |
| Universitatsklinikum Bonn | Bonn | 53127 | Germany |
| Auckland Clinical Studies Ltd | Grafton | Auckland | 1010 | New Zealand |
| Christchurch Clinical Studies Trust, Ltd | Christchurch | 8011 | New Zealand |
| Kings College Hospital NHS Trust | London | SE5 9RS | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set included all participants who took at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | SOF/VEL/VOX | SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks |
| 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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| Ethnicity (NIH/OMB) | 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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| HCV Genotype | 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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| Cirrhosis Status | Count of Participants | Participants |
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| HCV RNA (log10 IU/mL) | 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 (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 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 | Participants in the Safety Analysis Set were analyzed. | Posted | Number | percentage of participants | Up to Week 12 |
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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. | Participants in the Full Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Week 4 |
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| Secondary | Percentage of Participants With HCV RNA < LLOQ On Treatment | Participants in the Full Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 2, 4, 8, and 12 |
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| Secondary | Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Up to Posttreatment Week 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; Weeks 2, 4, 8, and 12 |
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Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12
Safety Analysis Set included all participants who took 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 | SOF/VEL/VOX | SOF/VEL/VOX (400/100/100 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks | 0 | 31 | 1 | 31 | 17 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Version 20.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 20.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 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 |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 10, 2018 | Feb 6, 2019 | SAP_001.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 |
|---|---|
| C000654129 | sofosbuvir velpatasvir voxilaprevir drug combination |
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| Unknown or Not Reported |
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| Not Disclosed |
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| United States |
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| United Kingdom |
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| Australia |
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| France |
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| Germany |
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| Genotype 3 |
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| Genotype 4 |
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| Genotype 5 |
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| TT |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Week 2 |
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| Week 4 |
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| Week 8 |
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| Week 12 |
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| Change at Week 2 |
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| Change at Week 4 |
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| Change at Week 8 |
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| Change at Week 12 |
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