Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003387-43 | EudraCT Number |
Not provided
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The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDV/SOF 12 weeks | Experimental | LDV/SOF administered for 12 weeks |
|
| LDV/SOF+RBV 12 weeks | Experimental | LDV/SOF+RBV administered for 12 weeks. |
|
| LDV/SOF 24 weeks | Experimental | LDV/SOF administered for 24 weeks |
|
| LDV/SOF+RBV 24 weeks | Experimental | LDV/SOF+RBV administered for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDV/SOF | Drug | LDV/SOF 90/400 mg FDC tablet administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12) | SVR12 was defined as HCV RNA level < the lower limit of quantification (LLOQ, ie, < 25 copies/mL) 12 weeks after last dose of study drug. | Posttreatment Week 12 |
| Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug | The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized. | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug | SVR4 and SVR24 were defined as HCV RNA level < LLOQ at 4 and 24 weeks after discontinuation of study drug, respectively. | Posttreatment Weeks 4 and 24 |
| Percentage of Participants With HCV RNA < LLOQ at Week 2 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jenny Yang, Pharm D | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27553375 | Derived | Grebely J, Mauss S, Brown A, Bronowicki JP, Puoti M, Wyles D, Natha M, Zhu Y, Yang J, Kreter B, Brainard DM, Yun C, Carr V, Dore GJ. Efficacy and Safety of Ledipasvir/Sofosbuvir With and Without Ribavirin in Patients With Chronic HCV Genotype 1 Infection Receiving Opioid Substitution Therapy: Analysis of Phase 3 ION Trials. Clin Infect Dis. 2016 Dec 1;63(11):1405-1411. doi: 10.1093/cid/ciw580. Epub 2016 Aug 23. | |
| 26280786 |
Not provided
Not provided
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.
1015 participants were screened.
Participants were enrolled at a total of 100 study sites in the United States and Europe. The first participant was screened on 26 September 2012. The last study visit occurred on 30 April 2014.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | LDV/SOF 12 Weeks | Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet once daily for 12 weeks |
| FG001 | LDV/SOF+RBV 12 Weeks | LDV/SOF 90/400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 With HCV RNA < LLOQ at Week 4 | Week 4 |
| Percentage of Participants With HCV RNA < LLOQ at Week 8 | Week 8 |
| 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 |
| Percentage of Participants With Virologic Failure | On-treatment virologic failure was defined as:
Virologic 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 | Baseline to posttreatment Week 24 |
| La Jolla |
| California |
| United States |
| Long Beach | California | United States |
| Los Angeles | California | United States |
| Palo Alto | California | United States |
| Sacramento | California | United States |
| San Diego | California | United States |
| Aurora | Colorado | United States |
| Englewood | Colorado | United States |
| Washington D.C. | District of Columbia | United States |
| Gainesville | Florida | United States |
| Miami | Florida | United States |
| Orlando | Florida | United States |
| Tampa | Florida | United States |
| Wellington | Florida | United States |
| Atlanta | Georgia | United States |
| Decatur | Georgia | United States |
| Marietta | Georgia | United States |
| Chicago | Illinois | United States |
| Indianapolis | Indiana | United States |
| Baltimore | Maryland | United States |
| Lutherville | Maryland | United States |
| Boston | Massachusetts | United States |
| Detroit | Michigan | United States |
| Rochester | Minnesota | United States |
| Saint Paul | Minnesota | United States |
| Kansas City | Missouri | United States |
| St Louis | Missouri | United States |
| Hillsborough | New Jersey | United States |
| Albuquerque | New Mexico | United States |
| Santa Fe | New Mexico | United States |
| Manhasset | New York | United States |
| New York | New York | United States |
| The Bronx | New York | United States |
| Asheville | North Carolina | United States |
| Chapel Hill | North Carolina | United States |
| Durham | North Carolina | United States |
| Fayetteville | North Carolina | United States |
| Statesville | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Philadelphia | Pennsylvania | United States |
| Germantown | Tennessee | United States |
| Nashville | Tennessee | United States |
| Arlington | Texas | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Fairfax | Virginia | United States |
| Falls Church | Virginia | United States |
| Norfolk | Virginia | United States |
| Richmond | Virginia | United States |
| Seattle | Washington | United States |
| CHRU Lille | France |
| Clichy | France |
| Créteil | France |
| La Tronche | France |
| Lyon | France |
| Marseille | France |
| Nice | France |
| Paris | France |
| Berlin | Germany |
| Cologne | Germany |
| Düsseldorf | Germany |
| Essen | Germany |
| Frankfurt | Germany |
| Freiburg im Breisgau | Germany |
| Hamburg | Germany |
| Hanover | Germany |
| Mainz | Germany |
| Bologna | Italy |
| Brescia | Italy |
| Milan | Italy |
| Padova | Italy |
| Palermo | Italy |
| Roma | Italy |
| San Giovanni Rotondo | Italy |
| Torino | Italy |
| San Juan | Puerto Rico |
| Barcelona | Spain |
| Madrid | Spain |
| Málaga | Spain |
| Santander | Spain |
| Seville | Spain |
| Birmingham | Wstmid | United Kingdom |
| London | United Kingdom |
| Manchester | United Kingdom |
| Plymouth | United Kingdom |
| Derived |
| Younossi ZM, Elsheikh E, Stepanova M, Gerber L, Nader F, Stamm LM, Brainard DM, McHutchinson JG. Ledipasvir/sofosbuvir treatment of hepatitis C virus is associated with reduction in serum apolipoprotein levels. J Viral Hepat. 2015 Dec;22(12):977-82. doi: 10.1111/jvh.12448. Epub 2015 Aug 17. |
| 24725239 | Derived | Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, Romero-Gomez M, Zarski JP, Agarwal K, Buggisch P, Foster GR, Brau N, Buti M, Jacobson IM, Subramanian GM, Ding X, Mo H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Mangia A, Marcellin P; ION-1 Investigators. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014 May 15;370(20):1889-98. doi: 10.1056/NEJMoa1402454. Epub 2014 Apr 11. |
| FG002 | LDV/SOF 24 Weeks | LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks |
| FG003 | LDV/SOF+RBV 24 Weeks | LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set: participants were randomized and received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LDV/SOF 12 Weeks | LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks |
| BG001 | LDV/SOF+RBV 12 Weeks | LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks |
| BG002 | LDV/SOF 24 Weeks | LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks |
| BG003 | LDV/SOF+RBV 24 Weeks | LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks |
| BG004 | 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Hepatitis C Virus (HCV) RNA | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| HCV RNA Category | Number | participants |
| ||||||||||||||||
| HCV Genotype | There are variations of HCV which are all similar enough to be called HCV, but are distinct enough to be referred to as HCV genotypes. | Number | participants |
| |||||||||||||||
| IL28b Status | CC, CT, and TT alleles are different forms of the IL28b gene. | 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 With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Study Drug (SVR12) | SVR12 was defined as HCV RNA level < the lower limit of quantification (LLOQ, ie, < 25 copies/mL) 12 weeks after last dose of study drug. | Full Analysis Set: participants were randomized and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Posttreatment Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug | The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized. | Safety Analysis Set: participants were randomized and received at least 1 dose of study drug. | Posted | Number | percentage of participants | Up to 24 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Study Drug | SVR4 and SVR24 were defined as HCV RNA level < LLOQ at 4 and 24 weeks after discontinuation of study drug, respectively. | Full Analysis Set | Posted | Number | percentage of participants | Posttreatment Weeks 4 and 24 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HCV RNA < LLOQ at Week 2 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | Week 2 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HCV RNA < LLOQ at Week 4 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | Week 4 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HCV RNA < LLOQ at Week 8 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | percentage of participants | Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Failure | On-treatment virologic failure was defined as:
Virologic 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 | Full Analysis Set | Posted | Number | percentage of participants | Baseline to posttreatment Week 24 |
|
Up to 24 weeks plus 30 days
Safety Analysis Set: participants were randomized and 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 | LDV/SOF 12 Weeks | LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks | 1 | 214 | 140 | 214 | ||
| EG001 | LDV/SOF+RBV 12 Weeks | LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks | 7 | 217 | 168 | 217 | ||
| EG002 | LDV/SOF 24 Weeks | LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks | 18 | 217 | 149 | 217 | ||
| EG003 | LDV/SOF+RBV 24 Weeks | LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks | 7 | 217 | 189 | 217 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Factor VIII inhibition | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Progressive multifocal leukoencephalopathy | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Salpingitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Substance abuse | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (16.0) | 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 |
| D006505 | Hepatitis |
| D006521 | Hepatitis, Chronic |
| D006526 | Hepatitis C |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D018178 | Flaviviridae Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000595958 | ledipasvir, sofosbuvir drug combination |
Not provided
Not provided
Not provided
| Male |
|
| White |
|
| Asian |
|
| American Indian/Alaska Native |
|
| Hawaiian or Pacific Islander |
|
| Other |
|
| Not Disclosed |
|
| Not Hispanic or Latino |
|
| Not Disclosed |
|
| United States |
|
| Spain |
|
| Germany |
|
| United Kingdom |
|
| Italy |
|
| ≥ 800,000 IU/mL |
|
| Genotype 1b |
|
| Genotype 1 (no confirmed subtype) |
|
| Genotype 4 |
|
| Missing |
|
| CT |
|
| TT |
|
| <0.001 |
The p-value for the comparison of the LDV/SOF+RBV 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test. |
| 2-Sided |
| Superiority or Other |
| Binomial test | <0.001 | The p-value for the comparison of the LDV/SOF 24 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test. | 2-Sided | Superiority or Other |
| Binomial test | <0.001 | The p-value for the comparison of the LDV/SOF+RBV 24 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test. | 2-Sided | Superiority or Other |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
| Participants |
|
|
LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks |
| OG003 | LDV/SOF+RBV 24 Weeks | LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks |
|
|