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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003001-42 | EudraCT Number |
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The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) 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 for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF/VEL | Drug | 400/100 mg FDC tablet administered orally once daily |
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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) at 12 weeks after stopping study treatment. | Posttreatment Week 12 |
| Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event | Up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HCV RNA < LLOQ 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 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 |
|---|---|---|---|---|---|---|
| Krasnoyarsk Regional Center of AIDS Prevention | Krasnoyarsk | Russia | ||||
| Central Research Institute of Epidemiology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Weiland O, Zhdanov K, Chulanov VP, McNabb BL, Lu S, Svarovskaia EU, et al. Safety and Efficacy of Sofosbuvir/Velpatasvir in a Genotype 1-3 HCV Infected Russian and Swedish Population: Results from a Phase 3, Prospective Trial [Abstract 1186]. Hepatology 2017;66 (1):639A. | ||
| 30499360 | Derived | Isakov V, Chulanov V, Abdurakhmanov D, Burnevich E, Nurmukhametova E, Kozhevnikova G, Gankina N, Zhuravel S, Romanova S, Hyland RH, Lu S, Svarovskaia ES, McNally J, Brainard DM, Ivashkin V, Morozov V, Bakulin I, Lagging M, Zhdanov K, Weiland O. Sofosbuvir/velpatasvir for the treatment of HCV: excellent results from a phase-3, open-label study in Russia and Sweden. Infect Dis (Lond). 2019 Feb;51(2):131-139. doi: 10.1080/23744235.2018.1535186. Epub 2018 Nov 30. |
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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.
122 participants were screened.
Participants were enrolled at study sites in the Russian Federation and Sweden. The first participant was screened on 04 April 2016 and the last study visit occurred on 13 September 2017.
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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, with or without food |
| 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 | Jul 17, 2015 | May 31, 2018 |
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SVR24 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 at Week 1 | Week 1 |
| Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2 | Week 2 |
| Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4 | Week 4 |
| Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8 | Week 8 |
| Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12 | Week 12 |
| Change From Baseline in HCV RNA at Week 1 | Baseline (Day 1); Week 1 |
| Change From Baseline in HCV RNA at Week 2 | Baseline (Day 1); Week 2 |
| Change From Baseline in HCV RNA at Week 4 | Baseline (Day 1); Week 4 |
| Change From Baseline in HCV RNA at Week 8 | Baseline (Day 1); Week 8 |
| Change From Baseline in HCV RNA at Week 12 | Baseline (Day 1); Week 12 |
| Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| Up to Posttreatment Week 24 |
| Moscow |
| Russia |
| Central Scientific-Research Institute of Epidemiology | Moscow | Russia |
| City Clinical Hospital # 24 | Moscow | Russia |
| First Moscow Medical University I.M.Sechenov. | Moscow | Russia |
| First Moscow State Medical University I.M. Sechenov | Moscow | Russia |
| Limited Liability Company "Clinic Tour" | Moscow | Russia |
| Scientific Research Institute of Nutrition | Moscow | Russia |
| Sklifosovsky Scientific Research Institution of Emergency Care | Moscow | Russia |
| Center for Prevention and Control of AIDS and Infectious Diseases | Saint Petersburg | Russia |
| Kirov Medical Military Academy | Saint Petersburg | Russia |
| North-Western State Medical University named after I.I. Mechnikov | Saint Petersburg | Russia |
| LLC Medical Company "Hepatolog" | Samara | Russia |
| Sahlgrenska Universitetsjukhuset | Gothenburg | Sweden |
| Karolinska University Hospital Huddinge | Stockholm | Sweden |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set: all 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, with or without food |
| 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 (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment. | Full Analysis Set: participants who 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 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 HCV RNA < LLOQ 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 HCV RNA < LLOQ at 24 Weeks After Discontinuation of Therapy (SVR24) | SVR24 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 at Week 1 | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Week 1 |
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| Secondary | Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 2 | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Week 2 |
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| Secondary | Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 4 | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
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| Secondary | Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 8 | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Week 8 |
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| Secondary | Percentage of Participants With HCV RNA < LLOQ on Treatment at Week 12 | Full Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
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| Secondary | Change From Baseline in HCV RNA at Week 1 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline (Day 1); Week 1 |
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| Secondary | Change From Baseline in HCV RNA at Week 2 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline (Day 1); Week 2 |
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| Secondary | Change From Baseline in HCV RNA at Week 4 | Full Analysis Set | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline (Day 1); Week 4 |
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| Secondary | Change From Baseline in HCV RNA at Week 8 | Full Analysis Set | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline (Day 1); Week 8 |
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| Secondary | Change From Baseline in HCV RNA at Week 12 | Full Analysis Set | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline (Day 1); 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 + 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) |
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| EG000 | SOF/VEL | SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks, with or without food | 0 | 119 | 4 | 119 | 29 | 119 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Orchitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
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| Calculus urinary | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA (20.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (20.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (20.0) | 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 | |
|---|---|---|---|---|
| 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 | Dec 3, 2015 | May 31, 2018 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 17, 2017 | May 31, 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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