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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-000417-73 | 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) and SOF/VEL FDC and ribavirin (RBV) for 12 weeks in participants with chronic genotype 3 hepatitis C virus (HCV) infection and compensated cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF/VEL | Experimental | SOF/VEL FDC for 12 weeks |
|
| SOF/VEL + RBV | Experimental | SOF/VEL FDC + RBV 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 Cessation 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 (Which Included SOF/VEL and RBV) Due to Any Adverse Event | Posttreatment Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4) | SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 4 weeks after stopping study treatment. | Posttreatment Week 4 |
| Percentage of Participants Who Have HCV RNA < LLOQ at Week 2 |
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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 |
|---|---|---|---|---|---|---|
| Hospital Universitario Marques de Valdecilla | Santander | Cantabria | Spain | |||
| Hospital Universitario de A Coruña |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29958855 | Derived | Esteban R, Pineda JA, Calleja JL, Casado M, Rodriguez M, Turnes J, Morano Amado LE, Morillas RM, Forns X, Pascasio Acevedo JM, Andrade RJ, Rivero A, Carrion JA, Lens S, Riveiro-Barciela M, McNabb B, Zhang G, Camus G, Stamm LM, Brainard DM, Subramanian GM, Buti M. Efficacy of Sofosbuvir and Velpatasvir, With and Without Ribavirin, in Patients With Hepatitis C Virus Genotype 3 Infection and Cirrhosis. Gastroenterology. 2018 Oct;155(4):1120-1127.e4. doi: 10.1053/j.gastro.2018.06.042. Epub 2018 Jun 27. |
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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.
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Participants were enrolled at study sites in Spain. The first participant was screened on 29 July 2016. The last study visit occurred on 27 October 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF/VEL | Sofosbuvir/velpatasvir (SOF/VEL) 400/100 mg fixed-dose combination (FDC) tablet once daily for 12 weeks |
| FG001 | SOF/VEL + RBV | SOF/VEL 400/100 mg FDC tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) 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: Original | Mar 16, 2016 | Sep 6, 2018 |
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| RBV | Drug | RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) |
|
| Week 2 |
| Percentage of Participants Who Have HCV RNA < LLOQ at Week 4 | Week 4 |
| Percentage of Participants Who Have HCV RNA < LLOQ at Week 8 | Week 8 |
| Percentage of Participants Who Have HCV RNA < LLOQ at Week 12 | Week 12 |
| HCV RNA at Week 2 | Week 2 |
| HCV RNA at Week 4 | Week 4 |
| HCV RNA at Week 8 | Week 8 |
| HCV RNA at Week 12 | Week 12 |
| Change From Baseline in HCV RNA at Week 2 | Baseline; Week 2 |
| Change From Baseline in HCV RNA at Week 4 | Baseline; Week 4 |
| Change From Baseline in HCV RNA at Week 8 | Baseline; Week 8 |
| Change From Baseline in HCV RNA at Week 12 | Baseline; Week 12 |
| Percentage of Participants With Virologic Failure | Virologic failure was defined as
| Up to Posttreatment Week 12 |
| A Coruña |
| Spain |
| Hospital Universitario Fundacion Alcorcon | Alcorcón | Spain |
| Hospital General Universitario De Alicante | Alicante | Spain |
| Complejo Hospitalario Torrecárdenas | Almería | Spain |
| Hospital Germans Trias i Pujol | Badalona | Spain |
| Hospital Universitario Valle Hebron | Barcelona | 8035 | Spain |
| Hospital Clínic de Barcelona | Barcelona | Spain |
| Hospital del Mar | Barcelona | Spain |
| Hospital Universitari de Bellvitge | Barcelona | Spain |
| Servei de d'Aparell Digestiu Corporació Sanitària Parc Taulí | Barcelona | Spain |
| Reina Sofía University Hospital | Córdoba | Spain |
| Hospital Universitario Donostia | Donostia / San Sebastian | Spain |
| Hospital Puerta De Hierro Majadahonda | Madrid | Spain |
| Hospital Ramón y Cajal | Madrid | Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| Hospital Universitario Virgen de la Victoria | Málaga | Spain |
| Hospital Universitario Virgen De La Arrixaca | Murcia | Spain |
| Hospital Universitario Central de asturias | Oviedo | Spain |
| Complexo Hospitalario Universitario de Montecelo | Pontevedra | Spain |
| Hospital Univ. NuestraSeñora Candelaria | Santa Cruz de Tenerife | Spain |
| Hospital de Valme | Seville | Spain |
| Hospital Universitario Virgen Del Rocio | Seville | Spain |
| Hospital Clinico Universitario | Valencia | Spain |
| Hospital General Valencia | Valencia | Spain |
| La Fe Hospital | Valencia | Spain |
| Hospital Universitario Alvaro Cunqueiro | Vigo | Spain |
| Hospital Clinico Universitario | Zaragoza | Spain |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set: participants who took at least 1 dose of any study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | SOF/VEL | SOF/VEL 400/100 mg FDC tablet once daily for 12 weeks |
| BG001 | SOF/VEL + RBV | SOF/VEL 400/100 mg FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks |
| BG002 | Total | Total of all reporting groups |
| 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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| IL28B | 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 Cessation 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: all randomized participants who took at least 1 dose of any 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 (Which Included SOF/VEL and RBV) Due to Any Adverse Event | Safety Analysis Set | Posted | Number | percentage of participants | Posttreatment Week 12 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Attain Sustained Virologic Response at 4 Weeks After Cessation of the Study Treatment Regimen (SVR4) | SVR4 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 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 Who Have HCV RNA < LLOQ at Week 2 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 2 |
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| Secondary | Percentage of Participants Who Have HCV RNA < LLOQ at Week 4 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 4 |
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| Secondary | Percentage of Participants Who Have HCV RNA < LLOQ at Week 8 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 8 |
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| Secondary | Percentage of Participants Who Have HCV RNA < LLOQ at Week 12 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 12 |
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| Secondary | HCV RNA at Week 2 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Week 2 |
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| Secondary | HCV RNA at Week 4 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Week 4 |
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| Secondary | HCV RNA at Week 8 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Week 8 |
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| Secondary | HCV RNA at Week 12 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Week 12 |
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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; Week 2 |
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| Secondary | Change From Baseline in HCV RNA at Week 4 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Week 4 |
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| Secondary | Change From Baseline in HCV RNA at Week 8 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Week 8 |
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| Secondary | Change From Baseline in HCV RNA at Week 12 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; 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 12 |
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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 | SOF/VEL 400/100 mg FDC tablet once daily for 12 weeks | 0 | 101 | 4 | 101 | 24 | 101 |
| EG001 | SOF/VEL + RBV | SOF/VEL 400/100 mg FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks | 0 | 103 | 2 | 103 | 55 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pharyngotonsillitis | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Version 20.0 | Systematic Assessment |
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| Accident at work | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDRA Version 20.0 | Systematic Assessment |
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| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.0 | Systematic Assessment |
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| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.0 | Systematic Assessment |
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| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 20.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Version 20.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA Version 20.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 20.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 20.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 20.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 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: Protocol Amendment 1 | Apr 4, 2016 | Sep 6, 2018 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 8, 2017 | Sep 6, 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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| Male |
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| Asian |
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| Not Hispanic or Latino |
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| Non-CC |
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| Missing |
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| ≥ 800,000 IU/mL |
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