Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003625-42 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objectives of this study are to evaluate safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF/VEL | Experimental | SOF/VEL for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF/VEL | Drug | 400/100 mg fixed-dose combination (FDC) tablet(s) administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping the study treatment. | Posttreatment Week 12 |
| Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event | First dose date up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) | SVR4 was defined as HCV RNA < LLOQ 4 weeks after stopping study treatment. | Posttreatment Week 4 |
| Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24) |
Not provided
Key Inclusion Criteria:
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia | ||
| Kaye Edmonton Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Borgia SM, Dearden J, Lurie Y, Shafran SD, Brown A, Hyland RH, et al. Sofosbuvir/Velpatasvir for 12 Weeks Is Safe and Effective in Patients Undergoing Dialysis. American Association for the Study of Liver Diseases (AASLD); 2018 09-13 November; San Francisco, CA. | ||
| 31195062 | Derived | Borgia SM, Dearden J, Yoshida EM, Shafran SD, Brown A, Ben-Ari Z, Cramp ME, Cooper C, Foxton M, Rodriguez CF, Esteban R, Hyland R, Lu S, Kirby BJ, Meng A, Markova S, Dvory-Sobol H, Osinusi AO, Bruck R, Ampuero J, Ryder SD, Agarwal K, Fox R, Shaw D, Haider S, Willems B, Lurie Y, Calleja JL, Gane EJ. Sofosbuvir/velpatasvir for 12 weeks in hepatitis C virus-infected patients with end-stage renal disease undergoing dialysis. J Hepatol. 2019 Oct;71(4):660-665. doi: 10.1016/j.jhep.2019.05.028. Epub 2019 Jun 11. |
Not provided
Not provided
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.
78 participants were screened.
Participants were enrolled at study sites in Canada, the United Kingdom, Spain, Israel, New Zealand, and Australia. The first participant was screened on 22 March 2017. The last study visit occurred on 07 November 2018.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SOF/VEL | Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 2, 2017 | Jul 9, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
SVR24 was defined as HCV RNA < LLOQ 24 weeks after stopping study treatment. |
| Posttreatment Week 24 |
| Change From Baseline in HCV RNA | Baseline; Weeks 2, 4, 6, 8, and 12 |
| Percentage of Participants With HCV RNA < LLOQ on Treatment | Weeks 2, 4, 6, 8, and 12 |
| Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| Baseline to Posttreatment Week 24 |
| Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment | Baseline deep sequencing of the HCV NS5A and NS5B genes was performed for all participants. For all participants with virologic failure, deep sequencing was performed at the first time point after virologic failure if the plasma or serum sample was available and HCV RNA was > 1000 IU/mL. | First dose date up to Posttreatment Week 24 |
| Pharmacokinetic (PK) Parameter: AUCtau of SOF | AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. | Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1)) |
| PK Parameter: AUCtau of GS-331007 (Metabolite of SOF) | AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. | Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1)) |
| PK Parameter: AUCtau of VEL | AUCtau is defined as the population PK derived area under the concentration verses time curve of the drug over the dosing interval. | Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1)) |
| PK Parameter: Cmax of SOF | Cmax is defined as the population PK derived maximum concentration of the drug. | Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1)) |
| PK Parameter: Cmax of GS-331007 (Metabolite of SOF) | Cmax is defined as the population PK derived maximum concentration of the drug. | Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1)) |
| PK Parameter: Cmax of VEL | Cmax is defined as the population PK derived maximum concentration of the drug. | Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1)) |
| PK Parameter: Ctau of VEL | Ctau is defined as the population PK derived concentration of the drug at the end of a 24 hour dosing interval. The 24 hour Ctau is estimated based on the combination of sparse PK samples collected at random times across the dosing interval as well as intensive PK samples collected for up to 12 hours post-dose. | Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1)) |
| Edmonton |
| Alberta |
| Canada |
| Gordon and Leslie Diamond Health Care Center, Vancouver General Hospital, UBC Division of Gastroenterology | Vancouver | British Columbia | BC V5Z 1M9 | Canada |
| William Osler Health System- Brampton Civic Hospital | Brampton | Ontario | Canada |
| Hamilton Health Sciences - McMaster University Medical Centre Site | Hamilton | Ontario | ON L8V | Canada |
| Ottawa Hospital Research Institute | Ottawa | Ontario | K1H 8L6 | Canada |
| Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM) | Montreal | Quebec | H2X 3J4 | Canada |
| Shaare Zedek Medical Center | Jerusalem | 9103102 | Israel |
| The Chaim Sheba Medical Centre | Ramat Gan | 52173 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| Auckland City Hospital | Grafton | Auckland | 1010 | New Zealand |
| Hospital Universitario Fundación Alcorcón | Alcorcón | Madrid | 28922 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario Puerta de Hierro - Majadahonda | Majadahonda | 28222 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | 41013 | Spain |
| Gartnavel General Hospital | Glasgow | G12 0YN | United Kingdom |
| Barts Health NHS Trust | London | E1 1BB | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| Chelsea and Westminster Hospital | London | SW10 9NH | United Kingdom |
| Imperial College Healthcare NHS Trust | London | W2 1NY | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | NG5 1PB | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SOF/VEL (GT-1) | SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection |
| BG001 | SOF/VEL (GT-2) | SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection |
| BG002 | SOF/VEL (GT-3) | SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection |
| BG003 | SOF/VEL (GT-4) | SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection |
| BG004 | SOF/VEL (GT-6) | SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection |
| BG005 | SOF/VEL (Indeterminate) | SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection |
| BG006 | 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 | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| IL28b Status | The CC, CT, and TT alleles are different forms of the IL28b gene. | Count of Participants | Participants | No |
| ||||||||||||||
| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| HCV RNA Category | 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 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping the study treatment. | The Full Analysis Set included participants who are enrolled into the study and received at least 1 dose of study drug. | 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 | The Safety Analysis Set included all participants who received at least 1 dose of study drug. | Posted | Number | percentage of participants | First dose date up to Week 12 |
|
|
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4) | SVR4 was defined as HCV RNA < LLOQ 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 Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24) | SVR24 was defined as HCV RNA < LLOQ 24 weeks after stopping study treatment. | Participants in the Full Analysis Set were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Week 24 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in HCV RNA | Participants in the Full Analysis Set with available date were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Weeks 2, 4, 6, 8, and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| 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, 6, 8, and 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| 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 | Baseline to Posttreatment Week 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment | Baseline deep sequencing of the HCV NS5A and NS5B genes was performed for all participants. For all participants with virologic failure, deep sequencing was performed at the first time point after virologic failure if the plasma or serum sample was available and HCV RNA was > 1000 IU/mL. | Participants in the Resistance Analysis Population Set included all participants in the Safety Analysis Set with a virologic outcome and at least 1 gene sequenced. All data are reported at a 15% assay cutoff. | Posted | Count of Participants | Participants | No | First dose date up to Posttreatment Week 24 |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic (PK) Parameter: AUCtau of SOF | AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. | Participants in the PK Analysis Set (all participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose concentration value for the corresponding analyte in plasma) with available data were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state AUCtau of SOF. | Posted | Mean | Standard Deviation | h*ng/mL | Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1)) |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PK Parameter: AUCtau of GS-331007 (Metabolite of SOF) | AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval. | Participants in the PK analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state AUCtau of GS-331007 . | Posted | Mean | Standard Deviation | h*ng/mL | Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1)) |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PK Parameter: AUCtau of VEL | AUCtau is defined as the population PK derived area under the concentration verses time curve of the drug over the dosing interval. | Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state AUCtau of VEL. | Posted | Mean | Standard Deviation | h*ng/mL | Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1)) |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PK Parameter: Cmax of SOF | Cmax is defined as the population PK derived maximum concentration of the drug. | Participants in the PK Analysis set with available data were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Cmax of SOF. | Posted | Mean | Standard Deviation | ng/mL | Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1)) |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PK Parameter: Cmax of GS-331007 (Metabolite of SOF) | Cmax is defined as the population PK derived maximum concentration of the drug. | Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Cmax of GS-331007. | Posted | Mean | Standard Deviation | ng/mL | Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1)) |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PK Parameter: Cmax of VEL | Cmax is defined as the population PK derived maximum concentration of the drug. | Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Cmax of VEL. | Posted | Mean | Standard Deviation | ng/mL | Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1)) |
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Secondary | PK Parameter: Ctau of VEL | Ctau is defined as the population PK derived concentration of the drug at the end of a 24 hour dosing interval. The 24 hour Ctau is estimated based on the combination of sparse PK samples collected at random times across the dosing interval as well as intensive PK samples collected for up to 12 hours post-dose. | Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Ctau of VEL. | Posted | Mean | Standard Deviation | ng/mL | Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1)) |
|
|
Adverse Events: First dose date up to Week 12 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
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 orally once daily for 12 weeks | 2 | 59 | 11 | 59 | 33 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Lower respiratory tract infection viral | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Post procedural swelling | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Pubis fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
| |
| Neurilemmoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | 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 | Sep 5, 2018 | Jul 9, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000611331 | sofosbuvir-velpatasvir drug combination |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| CT |
|
| TT |
|
| ≥ 800,000 IU/mL |
|
| Denominators |
|---|
| Categories |
|---|
|
| OG004 |
| SOF/VEL (GT-4) |
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection |
| OG005 | SOF/VEL (GT-6) | SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection |
| OG006 | SOF/VEL (Indeterminate) | SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection |
|
|
| OG004 |
| SOF/VEL (GT-4) |
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection |
| OG005 | SOF/VEL (GT-6) | SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection |
| OG006 | SOF/VEL (Indeterminate) | SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection |
|
|
| OG005 | SOF/VEL (GT-6) | SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection |
| OG006 | SOF/VEL (Indeterminate) | SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection |
|
|
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
| OG005 | SOF/VEL (GT-6) | SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection |
| OG006 | SOF/VEL (Indeterminate) | SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection |
|
|
| SOF/VEL (GT-3) |
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection |
| OG004 | SOF/VEL (GT-4) | SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection |
| OG005 | SOF/VEL (GT-6) | SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection |
| OG006 | SOF/VEL (Indeterminate) | SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection |
|
|
|
|
|
|
|
|
|
|
|
|
|
|