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The primary objective of this study is to evaluate the antiviral efficacy of treatment with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) therapy at the time of liver transplantation and through 4 weeks posttransplant in adults with genotype 1 or 4 hepatitis C virus (HCV) infection who are undergoing primary liver transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDV/SOF | Experimental | Participants with genotype 1 or 4 HCV who are undergoing liver transplant will receive one dose of LDV/SOF prior to the transplant and then will receive LDV/SOF once daily for 4 weeks following the transplant. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDV/SOF | Drug | 90/400 mg FDC tablet administered orally |
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| 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 Prematurely Discontinued Study Drug Due to an Adverse Event | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) | SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. | Posttreatment Week 4 |
| Percentage of Participants With Virologic Failure |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27959735 | Result | Levitsky J, Verna EC, O'Leary JG, Bzowej NH, Moonka DK, Hyland RH, Arterburn S, Dvory-Sobol H, Brainard DM, McHutchison JG, Terrault NA. Perioperative Ledipasvir-Sofosbuvir for HCV in Liver-Transplant Recipients. N Engl J Med. 2016 Nov 24;375(21):2106-2108. doi: 10.1056/NEJMc1611829. No abstract available. |
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Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
18 months after study completion
A secured external environment with username, password, and RSA code.
36 participants were screened. 17 unique participants were enrolled into the study (3 received the Day -1 dose and had their transplant cancelled; 2 of these patients were re-enrolled into the Main Study; the 3rd was rescreened but not transplanted).
Participants were enrolled at study sites in the United States. The first participant was screened on 22 May 2015. The last study visit occurred on 22 April 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | LDV/SOF | LDV/SOF for 1 Day: 3 participants were called for transplant, received one dose of ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg), but had their liver transplant cancelled. All 3 participants were rescreened and 2 were subsequently re-enrolled, transplanted, and continued into the Main Study. Main Study (LDV/SOF 4 Weeks): One dose of ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 hepatitis C virus (HCV) infection. Retreatment (LDV/SOF 12 Weeks): Participants who completed treatment in the Main Study and experienced virologic failure had the option to be retreated with LDV/SOF for 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Main Study (LDV/SOF 4 Weeks) |
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Virologic failure was defined as:
End of treatment virologic failure:
Virologic relapse:
| Up to Posttreatment Week 12 |
| Percentage of Participants With HCV RNA < LLOQ While on Treatment at Days 1, 3, 5, 7, 14, 21, and 28 | Days 1, 3, 5, 7, 14, 21, and 28 |
| Chicago |
| Illinois |
| United States |
| New Orleans | Louisiana | United States |
| Detroit | Michigan | United States |
| New York | New York | United States |
| Dallas | Texas | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Retreatment (LDV/SOF 12 Weeks) |
|
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug during the Main Study
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| ID | Title | Description |
|---|---|---|
| BG000 | Main Study (LDV/SOF 4 Weeks) | One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection |
| 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 |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| HCV Genotype | Count of Participants | Participants |
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| IL28b Status | The CC, CT, and TT alleles are different forms of the IL28b gene. | Count of Participants | Participants |
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| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
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| HCV RNA Category | Count of Participants | Participants |
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| Prior HCV Treatment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After 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. | Full Analysis Set: participants who were enrolled into the study, received a liver transplant while on study, and received 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 Prematurely Discontinued Study Drug Due to an Adverse Event | Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug | Posted | Number | percentage of participants | Up to 4 weeks |
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| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4) | SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. | Full Analysis Set: participants who were enrolled into the study, received a liver transplant while on study, and received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Week 4 |
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| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| Full Analysis Set: participants who were enrolled into the study, received a liver transplant while on study, and received at least 1 dose of study drug | Posted | Number | percentage of participants | Up to Posttreatment Week 12 |
|
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| Secondary | Percentage of Participants With HCV RNA < LLOQ While on Treatment at Days 1, 3, 5, 7, 14, 21, and 28 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Days 1, 3, 5, 7, 14, 21, and 28 |
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LDV/SOF for 1 Day: After pre-dose to minimum of 30 days or restart of LDV/SOF; Main Study: After pretransplant dose up to 4 weeks plus 30 days; Retreatment: After pretransplant dose up to 12 weeks plus 30 days
Safety Analysis Set: participants who were enrolled into the study and received 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 | LDV/SOF for 1 Day | Adverse events reported in this group include participants who received LDV/SOF on Day -1, but did not receive a liver transplant. All 3 participants were rescreened, but only 2 were re-enrolled, transplanted, and received LDV/SOF for 4 weeks. | 0 | 3 | 0 | 3 | 1 | 3 |
| EG001 | Main Study (LDV/SOF 4 Weeks) | Adverse events reported in this group include participants with chronic genotype 1 HCV infection who received one dose of LDV/SOF (90/400 mg) prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant. | 0 | 16 | 5 | 16 | 14 | 16 |
| EG002 | Retreatment (LDV/SOF 12 Weeks) | Adverse events reported in this group include 1 participant who completed treatment and experienced virologic failure in the Main Study and was retreated with an additional 12 weeks of LDV/SOF. | 0 | 1 | 0 | 1 | 1 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
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| Incision site cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Biliary anastomosis complication | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Hepatic artery flow decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
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| Detachment of retinal pigment epithelium | Eye disorders | MedDRA 18.1 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA 18.1 | Systematic Assessment |
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| Ocular icterus | Eye disorders | MedDRA 18.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Chills | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Drug withdrawal syndrome | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Impaired healing | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Oedema | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Peripheral swelling | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Cholestasis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
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| Jaundice | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
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| Transplant rejection | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Wound infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Incision site complication | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Incision site pain | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Electrocardiogram ST segment elevation | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Liver function test abnormal | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Urine output decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
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| Appetite disorder | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Cachexia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Dizziness postural | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Adjustment disorder with depressed mood | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
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| Micturition frequency decreased | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
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| Scrotal swelling | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Hair growth abnormal | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 18.1 | 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 | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D008107 | Liver Diseases |
| D012327 | RNA Virus Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D006505 | Hepatitis |
| D004066 | Digestive System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000595958 | ledipasvir, sofosbuvir drug combination |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| TT |
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| Title | Denominators | Categories | ||||
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| Title | Denominators | Categories | ||||
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| Day 3 |
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| Day 5 |
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| Day 7 |
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| Day 14 |
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| Day 21 |
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| Day 28 |
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