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This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus (HCV) infection as assessed by the proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF+RBV+placebo | Experimental | Participants were randomized to receive SOF+RBV for 12 weeks followed by placebo to match SOF plus placebo to match RBV for 4 weeks. |
|
| SOF+RBV | Experimental | Participants were randomized to receive SOF+RBV for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF | Drug | Sofosbuvir (SOF) 400 mg tablet was administered orally once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving SVR12 | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy. For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm). | Posttreatment Week 12 |
| Adverse Events Leading to Permanent Discontinuation of Study Drug | Adverse events which led to permanent discontinuation of study drug may or may not have been related to study treatment. | Baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving SVR4 | SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy. For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm). | Posttreatment Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SCTI Research Foundation | Coronado | California | 92118 | United States | ||
| Kaiser Permanente |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25583164 | Derived | Younossi ZM, Stepanova M, Sulkowski M, Naggie S, Puoti M, Orkin C, Hunt SL. Sofosbuvir and Ribavirin for Treatment of Chronic Hepatitis C in Patients Coinfected With Hepatitis C Virus and HIV: The Impact on Patient-Reported Outcomes. J Infect Dis. 2015 Aug 1;212(3):367-77. doi: 10.1093/infdis/jiv005. Epub 2015 Jan 12. | |
| 25040192 |
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277 participants were screened and 202 were randomized. Of those participants randomized, 201 received at least one dose of study drug, and comprise the Safety Analysis Set; 195 of those participants with genotypes 2 or 3 HCV infection were treated and comprise the Full Analysis Set.
Subjects were enrolled in a total of 57 study sites in the United States, Canada, and New Zealand. The first participant was screened on 04 June 2012. The last participant observation was on 08 May 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF+RBV+Placebo | Participants were randomized to receive sofosbuvir (SOF)+ribavirin (RBV) for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks. Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| RBV | Drug | Ribavirin (RBV) tablets was administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg). |
|
| Placebo to match SOF | Drug | Placebo to match SOF was administered orally once daily. |
|
| Placebo to match RBV | Drug | Placebo to match RBV was administered orally twice daily. |
|
| Percentage of Participants Achieving SVR24 |
SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy. For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm). |
| Posttreatment Week 24 |
| Percentage of Participants With Viral Breakthrough | Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values. For the purposes of this efficacy analysis, assessments were made during active treatment (up to Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm). | Up to 16 weeks |
| Percentage of Participants With Viral Relapse | Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement. For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm). | End of treatment to posttreatment Week 24 |
| Los Angeles |
| California |
| 90027 |
| United States |
| Peter J. Ruane, MD, Inc. | Los Angeles | California | 90036 | United States |
| Anthony Mills MD, Inc. | Los Angeles | California | 90069 | United States |
| UCSD Antiviral Research Center | San Diego | California | 92103 | United States |
| Medical Associates Research Group, Inc. | San Diego | California | 92123 | United States |
| Kaiser Permanente | San Diego | California | 92154 | United States |
| Quest Clinical Research | San Francisco | California | 94115 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| South Denver Gastroenterology, PC | Englewood | Colorado | 80113 | United States |
| Whitman Walker Clinic | Washington D.C. | District of Columbia | 20009 | United States |
| University of Florida | Gainesville | Florida | 32610-0277 | United States |
| Borland-Groover Clinic Baptist | Jacksonville | Florida | 32256 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Advanced Research Institute | New Port Richey | Florida | 34653 | United States |
| Orlando Immunology Center (ACH) | Orlando | Florida | 32803-1851 | United States |
| Internal Medicine Specialists | Orlando | Florida | 32806 | United States |
| South Florida Center of Gastroenterology, P.A. | Wellington | Florida | 33414 | United States |
| Digestive Healthcare of Georgia | Atlanta | Georgia | 30309 | United States |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | United States |
| Indianapolis Gastroenterology Research Foundation | Indianapolis | Indiana | 46237 | United States |
| Graves-Gilbert Clinic | Bowling Green | Kentucky | 42101 | United States |
| Gastroenterology Associates, LLC | Baton Rouge | Louisiana | 70809 | United States |
| Johns Hopkins University | Lutherville | Maryland | 21093 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114-2696 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States |
| The Research Institute | Springfield | Massachusetts | 01105 | United States |
| Henry Ford Health System | Novi | Michigan | 48377 | United States |
| Minnesota Gastroenterology, P.A. | Minneapolis | Minnesota | 55414 | United States |
| Kansas City Gastroenterology and Hepatology | Kansas City | Missouri | 64131 | United States |
| Comprehensive Clinical Research | Berlin | New Jersey | 08009 | United States |
| ID Care | Hillsborough | New Jersey | 08844 | United States |
| Southwest C.A.R.E. Center | Santa Fe | New Mexico | 87505 | United States |
| Binghamton Gastroenterology Associates | Binghamton | New York | 13903 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Asheville Gastroenterology Associates, P.A. | Asheville | North Carolina | 28801 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Digestive Health Specialists, PA | Winston-Salem | North Carolina | 27103 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University Gastroenterology | Providence | Rhode Island | 02905 | United States |
| The Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Nashville Gastrointestinal Specialists, Inc | Nashville | Tennessee | 37211 | United States |
| Texas Clinical Research Institute, LLC | Arlington | Texas | 76012 | United States |
| Southwest Infectious Disease Clinical Research, Inc. | Dallas | Texas | 75219 | United States |
| Alamo Medical Research | San Antonio | Texas | 78215 | United States |
| Metropolitan Research | Fairfax | Virginia | 22031 | United States |
| Inova Fairfax Hospital Center for Liver Diseases | Falls Church | Virginia | 22042 | United States |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | United States |
| Bon Secours St. Mary's Hospital of Richmond, Inc. | Richmond | Virginia | 23226 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2X8 | Canada |
| Gordon & Leslie Diamond Health Care Centre | Vancouver | British Columbia | V5Z 1M9 | Canada |
| University of British Columbia | Vancouver | British Columbia | V6Z 2C9 | Canada |
| (G.I.R.I.) Gastrointestinal Research Institute | Vancouver | British Columbia | V6Z 2K5 | Canada |
| University of Manitoba Health Sciences Center | Winnipeg | Manitoba | R3E 3P4 | Canada |
| The Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| Toronto Liver Centre | Toronto | Ontario | M6H 3M1 | Canada |
| Hopital St. Luc | Montreal | Quebec | H2X 3J4 | Canada |
| Auckland Clinical Studies Limited | Auckland | 1640 | New Zealand |
| Christchurch Hospital | Christchurch | 8011 | New Zealand |
| Clinical Research Puerto Rico Inc | San Juan | PR | 00909-1711 | Puerto Rico |
| Fundacion De Investigacion De Diego | San Juan | PR | 00927 | Puerto Rico |
| Stepanova M, Nader F, Cure S, Bourhis F, Hunt S, Younossi ZM. Patients' preferences and health utility assessment with SF-6D and EQ-5D in patients with chronic hepatitis C treated with sofosbuvir regimens. Aliment Pharmacol Ther. 2014 Sep;40(6):676-85. doi: 10.1111/apt.12880. Epub 2014 Jul 15. |
| 23607593 | Derived | Jacobson IM, Gordon SC, Kowdley KV, Yoshida EM, Rodriguez-Torres M, Sulkowski MS, Shiffman ML, Lawitz E, Everson G, Bennett M, Schiff E, Al-Assi MT, Subramanian GM, An D, Lin M, McNally J, Brainard D, Symonds WT, McHutchison JG, Patel K, Feld J, Pianko S, Nelson DR; POSITRON Study; FUSION Study. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med. 2013 May 16;368(20):1867-77. doi: 10.1056/NEJMoa1214854. Epub 2013 Apr 23. |
| FG001 | SOF+RBV | Participants were randomized to receive sofosbuvir+RBV for 16 weeks. Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. |
| Enrolled and Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants in the Safety Analysis Set (randomized and received at least 1 dose of study drug) were analyzed for baseline characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | SOF+RBV+Placebo | Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks. Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets. |
| BG001 | SOF+RBV | Participants were randomized to receive sofosbuvir+RBV for 16 weeks. Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Hepatitis C Virus (HCV) genotype | Number | participants |
| ||||||||||||||||
| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| HCV RNA Category | Number | participants |
| ||||||||||||||||
| IL28 Genotype | CC, CT, and TT alleles are different forms of the IL28b gene. | Number | participants |
| |||||||||||||||
| Cirrhosis (Y/N) | Number | participants |
| ||||||||||||||||
| Response to Prior HCV Treatment | Number | participants |
|
| 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 Achieving SVR12 | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy. For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm). | The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Posttreatment Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Adverse Events Leading to Permanent Discontinuation of Study Drug | Adverse events which led to permanent discontinuation of study drug may or may not have been related to study treatment. | The Safety Analysis Set included participants who were randomized and received at least 1 dose of study drug. | Posted | Number | participants | Baseline to Week 16 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving SVR4 | SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy. For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm). | The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Posttreatment Week 4 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving SVR24 | SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy. For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm). | The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Posttreatment Week 24 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Viral Breakthrough | Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values. For the purposes of this efficacy analysis, assessments were made during active treatment (up to Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm). | The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to 16 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Viral Relapse | Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement. For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm). | The Full Analysis Set included all participants with genotype 2 or 3 HCV infection who were randomized and received at least 1 dose of study drug. | Posted | Number | participants | End of treatment to posttreatment Week 24 |
|
Baseline to posttreatment Week 24 plus 30 days
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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+RBV+Placebo | Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks. Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets. | 5 | 103 | 92 | 103 | ||
| EG001 | SOF+RBV | Participants were randomized to receive sofosbuvir+RBV for 16 weeks. Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. | 3 | 98 | 86 | 98 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA Version 15.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA Version 15.0 | Systematic Assessment |
| |
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 15.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 15.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 15.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 15.0 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 15.0 | 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 | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences, Inc. | ClinicalTrialDisclosures@gilead.com |
| 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 |
|---|---|
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
Not provided
Not provided
| Male |
|
| White |
|
| Asian |
|
| American Indian/ Alaska Native/ First Nations |
|
| Hawaiian or Pacific Islander |
|
| Other |
|
| Canada |
|
| New Zealand |
|
| Genotype 2 |
|
| Genotype 3 |
|
| ≥ 6 log10 IU/mL |
|
| CT |
|
| TT |
|
| Yes |
|
| Missing |
|
| Relapse/Breakthrough |
|
| Superiority or Other |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|