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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003066-10 | EudraCT Number |
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The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with ribavirin (RBV) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) Class C cirrhosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF/VEL+ RBV | Experimental | SOF/VEL FDC plus 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 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 Study Drug (SOF/VEL or RBV) 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) |
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Key Inclusion Criteria:
A body mass index (BMI) of ≥ 18 kg/m^2
Chronic HCV infection (≥ 6 months) as documented by either prior medical history or liver biopsy
Quantifiable HCV RNA at screening
Individuals may be non-transplanted or with recurrent HCV post-liver transplant.
CPT score of 10 to 12, inclusive, as determined at screening
Liver imaging within 6 months of Day 1 to exclude hepatocellular carcinoma (HCC)
If treatment-experienced, the most recent HCV treatment must have been completed at least 8 weeks prior to Screening
Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 prior to randomization
Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Females must agree to refrain from egg donation and in vitro fertilization during treatment until at least 30 days after the last dose of SOF/VEL or 6 months after the last dose of RBV, whichever occurs last
Lactating females must agree to discontinue nursing before the study drugs are administered
Males must agree to refrain from sperm donation from the date of screening until at least 7 months after the last dose of RBV or 30 days after the last dose of SOF/VEL, whichever occurs last
Adults must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
Key Exclusion Criteria:
Current or prior history of any of the following:
Any history of organ transplant other than liver or kidney
Chronic liver disease of a non-HCV etiology
Inability to exclude HCC by imaging within 6 months of Day 1
Alpha-fetoprotein (AFP) > 50 unless negative imaging for hepatic masses within the last 6 months or during screening
Active spontaneous bacterial peritonitis at screening
Infection requiring systemic antibiotics at the time of screening
Evidence of fibrosing cholestatic hepatitis at screening
Life threatening serious adverse event (SAE) during screening
Active variceal bleeding within 6 months of screening
Prior placement of a portosystemic shunt (such as TIPS)
ECG with clinically significant abnormalities
Laboratory parameters with clinically significant abnormalities
Hepatitis B surface antigen positive at screening
Infection with human immunodeficiency virus (HIV)
Clinically-relevant alcohol or drug abuse within 12 months of screening. A positive drug screen will exclude individuals unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the Investigator
Prior exposure to any HCV Non-structural Protein 5A (NS5A) inhibitor
Current use of corticosteroids at any dose >10 mg of prednisone/day (or equivalent dose of corticosteroid)
Use of any prohibited concomitant medications
Use of granulocyte macrophage colony-stimulating factor (GM-CSF), epoetin alfa or other hematopoietic stimulating agents within 2 weeks of screening
Male with pregnant female partner
History of clinically significant hemoglobinopathy (eg, sickle cell disease, thalassemia)
Contraindications to RBV therapy
Known hypersensitivity to VEL, RBV, SOF, the metabolites, or formulation excipients
Participation in a clinical study with an investigational drug or biologic within 3 months prior to Day 1
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 |
|---|---|---|---|---|---|---|
| Tampa General Medical Group | Tampa | Florida | 33606 | United States | ||
| Northwestern Memorial Hospital; Clinical Research Unit |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Flamm S, Lawitz E, Borg B, Charlton M, Landis C, Reddy R, et al. High Efficacy and Improvement in CPT Class With Sofosbuvir/Velpatasvir Plus Ribavirin for 12 Weeks in Patients With CPT C Decompensated Cirrhosis [Poster THU-138]. EASL: The International Liver Congress; 2019 10-14 April; Vienna, Austria. |
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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/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.
73 participants were screened.
Participants were enrolled at study sites in the United States and France. The first participant was screened on 23 January 2017. The last study visit occurred on 12 December 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF/VEL+ RBV | Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet once daily + ribavirin (RBV) tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and Child-Pugh-Turcotte (CPT) Class C cirrhosis |
| 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 | Nov 22, 2016 | Aug 12, 2019 |
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| RBV | Drug | Tablets administered orally at 600 mg, if well tolerated then up to a maximum total daily dose of 1000 to 1200 mg (based on weight) divided twice daily. |
|
SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment. |
| Posttreatment Week 24 |
| Percentage of Participants With HCV RNA < LLOQ While on Study Treatment | Weeks 2, 4, 8, and 12 |
| Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class | CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. Participants with no change CPT class was defined as having CPT Class same between Baseline and Posttreatment Week 24. | Baseline to Posttreatment Week 24 |
| Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score | MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. "No change" was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; "Decrease" was assigned for differences that were less than or equal to -2; and "Increase" was assigned for values that were greater than or equal to 2. | Baseline to Posttreatment Week 24 |
| Absolute HCV RNA Level Through Week 12 | Baseline; Weeks 2, 4, 8, and 12 |
| Change From Baseline in HCV RNA | Baseline; Weeks 2, 4, 8, and 12 |
| Number of Participants With Virologic Failure | Virologic failure was defined as:
| Baseline up to Posttreatment Week 24 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Digestive Disease Associates, PA | Catonsville | Maryland | 21228 | United States |
| Southern Therapy and Advanced Research LLC | Jackson | Mississippi | 39216 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| American Research Corporation at Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| Intermountain Liver Disease and Transplant Center | Murray | Utah | 84107 | United States |
| Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia | Richmond | Virginia | 23226 | United States |
| University of Washington/ Harborview Medical Center | Seattle | Washington | 98105 | United States |
| Hopital Henri Mondor | Créteil | 94010 | France |
| Hopital Paul Brousse | Villejuif | 94800 | France |
| 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 study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | SOF/VEL+ RBV | SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis |
| 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 |
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| Race/Ethnicity, Customized | Count of Participants | Participants | No |
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| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
| ||||||||||||||||||||||
| HCV RNA Category | Count of Participants | Participants | No |
| ||||||||||||||||||||||
| IL28B | The CC, CT, and TT alleles are different forms of the IL28b gene. | Count of Participants | Participants | No |
| |||||||||||||||||||||
| Child-Pugh-Turcotte Class | CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. | Count of Participants | Participants | No |
| |||||||||||||||||||||
| Model for End Stage Liver Disease (MELD) Score Category | MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. | 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) 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. | The 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 Study Drug (SOF/VEL or RBV) Due to an Adverse Event | The Safety Analysis Set included all participants who took 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 at 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 | Percentage of Participants With HCV RNA < LLOQ While on Study Treatment | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of participants | Weeks 2, 4, 8, and 12 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class | CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. Participants with no change CPT class was defined as having CPT Class same between Baseline and Posttreatment Week 24. | Participants in the Full Analysis Set who achieved SVR24 with available data were analyzed. | Posted | Number | Percentage of participants | Baseline to Posttreatment Week 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score | MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. "No change" was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; "Decrease" was assigned for differences that were less than or equal to -2; and "Increase" was assigned for values that were greater than or equal to 2. | Participants in the Full Analysis Set who achieved SVR24 with available data were analyzed. | Posted | Number | percentage of participants | Baseline to Posttreatment Week 24 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Absolute HCV RNA Level Through Week 12 | 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 |
| |||||||||||||||||||||||||||||||||||||
| 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 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Virologic Failure | Virologic failure was defined as:
| Participants in the Full Analysis Set were analyzed. | Posted | Count of Participants | Participants | No | Baseline up to Posttreatment Week 24 |
|
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 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+ RBV | SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis | 8 | 32 | 17 | 32 | 27 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Ventricular tachycardia | Cardiac disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Dermo-hypodermitis | Infections and infestations | MedDRA Version 21.0 | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA Version 21.0 | Systematic Assessment |
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| Escherichia sepsis | Infections and infestations | MedDRA Version 21.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA Version 21.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Version 21.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Version 21.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Systematic Assessment |
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| Mixed hepatocellular cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.0 | Systematic Assessment |
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| Hepatic encephalopathy | Nervous system disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Hepatic hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA Version 21.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Version 21.0 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Hepatic hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 21.0 | 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 |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 24, 2018 | Aug 12, 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 |
|---|---|
| C000611331 | sofosbuvir-velpatasvir drug combination |
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| Unknown or Not Reported |
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| White |
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| Not Permitted |
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| Other |
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| TT |
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| 21-25 MELD Score |
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| Discontinuation of SOF/VEL |
| |||||
| Discontinuation of RBV |
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SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis |
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SOF/VEL (400/100 mg) FDC tablet once daily + RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection and CPT Class C cirrhosis |
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| OG003 | SOF/VEL+ RBV (Total) | SOF/VEL (400/100 mg) FDC tablet once daily + ribavirin RBV tablet (600-1200 mg based on weight) divided twice daily for 12 weeks in participants with HCV infection and CPT Class C cirrhosis |
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