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The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC in participants with chronic HCV infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF/VEL | Experimental | Participants with chronic HCV infection (genotype 1 or 2), who are treatment-naive or treatment-experienced with interferon (IFN)-based treatments will receive SOF/VEL for 12 weeks. |
|
| SOF/VEL/VOX | Experimental | Participants with chronic HCV infection (genotype 1), who are treatment-experienced with nonstructural protein 5A (NS5A) direct-acting antiviral (DAA)-based treatments of at least 4 weeks duration will receive SOF/VEL/VOX for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF/VEL | Drug | 400/100 mg FDC tablet orally once daily. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Study Treatment | SVR12 was defined as HCV RNA < LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment. | Posttreatment Week 12 |
| Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event | First dose date up to 12 weeks plus 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With SVR < LLOQ 4 Weeks After Discontinuation of Study Treatment | SVR4 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) 4 weeks after stopping study treatment. | Posttreatment Week 4 |
| Percentage of Participants With Virologic Failure |
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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 |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-D | 13620 | South Korea | ||
| Inje University Busan Paik Hospital |
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
18 months after study completion
A secured external environment with username, password, and RSA code.
96 participants were screened.
Participants were enrolled at study sites in South Korea. The first participant was screened on 03 January 2020. The last study visit occurred on 12 November 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF/VEL | Participants with chronic hepatitis C virus (HCV) infection (genotype 1 or 2), who were treatment-naive or treatment-experienced with interferon (IFN)-based treatments received sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks. |
| FG001 |
| 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 | Oct 4, 2019 | Aug 31, 2021 |
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| SOF/VEL/VOX | Drug | 400/100/100 mg FDC tablet orally once daily. |
|
|
Virologic failure was defined as: On-treatment virologic failure:
Virologic relapse: • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit |
| Baseline up to Posttreatment Week 12 |
| Percentage of Participants With HCV RNA < LLOQ on Treatment | LLOQ was 15 IU/mL. | Week 2, Week 4, Week 8, Week 12 |
| Change From Baseline in HCV RNA | Baseline, Week 2, Week 4, Week 8, Week 12 |
| Number of Participants With Alanine Aminotransferase (ALT) Normalization | Number of participants with ALT normalization, defined as ALT > upper limit of normal (ULN) (ULN = 43 U/L) at baseline and ALT ≤ ULN, at each visit was presented. | Baseline, Week 2, Week 4, Week 8, Week 12 |
| Busan |
| 47392 |
| South Korea |
| Dong-A University Hospital | Busan | 48789 | South Korea |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Kyungpook National University Hospital | Daegu | 41944 | South Korea |
| Keimyung University Dongsan Hospital | Daegu | 42601 | South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| Chosun University Hospital | Gwangju | 501-717 | South Korea |
| The Catholic University of Korea, Incheon St. Mary's Hospital | Incheon | 21431 | South Korea |
| Gachon University Gil Medical Center | Incheon | 405-760 | South Korea |
| Chonbuk National University Hospital | Jeonju | 54907 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| VHS (Veterans Health Service) Medical Center | Seoul | 05368 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea, Seoul Saint Mary's Hospital | Seoul | 06591 | South Korea |
| Chung-Ang University Hospital | Seoul | 06973 | South Korea |
| SMG-SNU Boramae Medical Center | Seoul | 07061 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| Ulsan University Hospital | Ulsan | 44033 | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | 50612 | South Korea |
| SOF/VEL/VOX |
Participants with chronic HCV infection (genotype 1 or 2), who were treatment-experienced with nonstructural protein 5A (NS5A) direct-acting antiviral (DAA)-based treatments of at least a 4 weeks duration received sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) (400/100/100 mg) FDC tablet orally once daily for 12 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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The Safety Analysis Set included all participants who took at least 1 dose of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | SOF/VEL | Participants with chronic HCV infection (genotype 1 or 2), who were treatment-naive or treatment-experienced with IFN-based treatments received SOF/VEL 400/100 mg FDC tablet orally once daily for 12 weeks. |
| BG001 | SOF/VEL/VOX | Participants with chronic HCV infection (genotype 1 or 2), who were treatment-experienced with NS5A DAA-based treatments of at least a 4 weeks duration received SOF/VEL/VOX 400/100/100 mg FDC tablet 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, Categorical | Count of Participants | Participants | No |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||||
| Race/Ethnicity, Customized | Ethnicity Not Permitted: local regulators did not allow collection of ethnicity information. | Count of Participants | Participants | No |
| ||||||||||||||||
| Interleukin-28B gene (IL28b) Status | The CC, CT, and TT alleles are different forms of the IL28b gene. | Number | participants |
| |||||||||||||||||
| HCV RNA Category | Number | participants |
| ||||||||||||||||||
| Genotype | 1 participant with Genotype 2 in SOF/VEL/VOX arm was included because of eligibility criteria deviation. | Count of Participants | Participants | No |
|
| 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) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Study Treatment | SVR12 was defined as HCV RNA < LLOQ (i.e., 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 and had detectable HCV RNA at baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Week 12 |
|
|
| ||||||||||||||||||||||||||||
| Primary | Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event | Safety Analysis Set included all participants who took at least 1 dose of the study drug. | Posted | Number | percentage of participants | First dose date up to 12 weeks plus 30 days |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With SVR < LLOQ 4 Weeks After Discontinuation of Study Treatment | SVR4 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) 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 |
|
| |||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Failure | Virologic failure was defined as: On-treatment virologic failure:
Virologic relapse: • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Baseline up to Posttreatment Week 12 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HCV RNA < LLOQ on Treatment | LLOQ was 15 IU/mL. | Participants in the Full Analysis Set were analyzed. | Posted | Number | percentage of participants | Week 2, Week 4, Week 8, Week 12 |
|
| ||||||||||||||||||||||||||||||
| 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, Week 2, Week 4, Week 8, Week 12 |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Alanine Aminotransferase (ALT) Normalization | Number of participants with ALT normalization, defined as ALT > upper limit of normal (ULN) (ULN = 43 U/L) at baseline and ALT ≤ ULN, at each visit was presented. | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | participants | Baseline, Week 2, Week 4, Week 8, Week 12 |
|
|
From first dose date up to 12 weeks plus 30 days
The 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 | Participants with chronic HCV infection (genotype 1 or 2), who were treatment-naive or treatment-experienced with IFN-based treatments received SOF/VEL 400/100 mg FDC tablet orally once daily for 12 weeks. | 0 | 54 | 3 | 54 | 5 | 54 |
| EG001 | SOF/VEL/VOX | Participants with chronic HCV infection (genotype 1 or 2), who were treatment-experienced with NS5A-DAA based treatments of at least a 4 weeks duration received SOF/VEL/VOX 400/100/100 mg FDC tablet orally once daily for 12 weeks. | 0 | 33 | 1 | 33 | 8 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematochezia | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA Version 23.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 23.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 23.1 | 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 | |
|---|---|---|---|---|
| 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 | Dec 10, 2020 | Aug 31, 2021 | 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 |
|---|---|
| C000611331 | sofosbuvir-velpatasvir drug combination |
| C000654129 | sofosbuvir velpatasvir voxilaprevir drug combination |
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| >=65 years |
|
| Male |
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| Asian |
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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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| Not Permitted |
|
| CT |
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| TT |
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| Missing |
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| ≥ 800,000 IU/mL |
|
| Genotype 2 |
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| Counts |
|---|
| Participants |
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