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The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in hepatitis C virus (HCV)-infected adults who are undergoing liver transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF/VEL | Experimental | SOF/VEL FDC for 4 weeks starting on the day of or day after the participant's liver transplant |
|
| 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 Any Study Drug Due to an Adverse Event | Up to Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With SVR at 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 HCV RNA < LLOQ On Treatment |
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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 |
|---|---|---|---|---|---|---|
| Auckland | New Zealand |
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.
11 participants were screened.
Participants were enrolled at a study site in New Zealand. The first participant was screened on 12 June 2016. The last study visit occurred on 16 January 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | SOF/VEL | Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 4 weeks starting on the day of or day after the participant's liver transplant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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 | SOF/VEL (400/100 mg) FDC tablet orally once daily for 4 weeks starting on the day of or day after the participant's liver transplant. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 included all enrolled participants who received a liver transplant, and took at least 1 dose of study drug. | Posted | Number | 95% Confidence Interval | Percentage of participants | Posttreatment Week 12 |
|
|
Up to 4 weeks plus 30 days
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 | SOF/VEL (400/100 mg) FDC tablet orally once daily for 4 weeks starting on the day of or day after the participant's liver transplant. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Immune thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
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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 | Feb 26, 2016 | Nov 29, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 20, 2018 | Nov 29, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C000611331 | sofosbuvir-velpatasvir drug combination |
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| Days 3, 5, 7, 14, 21, and 28 |
| Percentage of Participants With Overall Virologic Failure | Virologic failure was defined as 1) End of Treatment Virologic Failure: HCV RNA ≥ 15 IU/mL at last observed HCV RNA measurement on or prior to last dose date of SOF/VEL + 3 days after completion of 28 ± 3 days of SOF/VEL treatment, or 2) Relapse: HCV RNA ≥ 15 IU/mL during the posttreatment follow-up period having achieved HCV RNA < 15 IU/mL at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement. | Up to Posttreatment Week 12 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Pre-Transplant Hepatitis C Virus (HCV) genotype | Count of Participants | Participants |
|
| Pre-Transplant IL28b Status | The CC, CT, and TT alleles are different forms of the IL28b gene. | Count of Participants | Participants |
|
| Pre-Transplant HCV RNA (log10 international units per milliliter (IU/mL)) | Mean | Standard Deviation | log10 IU/mL |
|
| Pre-Transplant HCV RNA Category | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | Safety Analysis Set | Posted | Number | Percentage of participants | Up to Week 4 |
|
|
|
| Secondary | Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) | SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment. | Full Analysis Set | Posted | Number | 95% Confidence Interval | Percentage of participants | Posttreatment Week 4 |
|
|
|
| Secondary | Percentage of Participants With HCV RNA < LLOQ On Treatment | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of participants | Days 3, 5, 7, 14, 21, and 28 |
|
|
|
| Secondary | Percentage of Participants With Overall Virologic Failure | Virologic failure was defined as 1) End of Treatment Virologic Failure: HCV RNA ≥ 15 IU/mL at last observed HCV RNA measurement on or prior to last dose date of SOF/VEL + 3 days after completion of 28 ± 3 days of SOF/VEL treatment, or 2) Relapse: HCV RNA ≥ 15 IU/mL during the posttreatment follow-up period having achieved HCV RNA < 15 IU/mL at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement. | Full Analysis Set | Posted | Number | Percentage of participants | Up to Posttreatment Week 12 |
|
|
|
| 1 |
| 9 |
| 5 |
| 9 |
| 9 |
| 9 |
| Pancreatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Multiple organ dysfunction syndrome | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cholangitis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Liver transplant rejection | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Post procedural bile leak | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Fluid intake reduced | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Intensive care unit acquired weakness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Tachyarrhythmia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Ascites | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Coeliac artery stenosis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Oedema | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Liver transplant rejection | Immune system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Cytomegalovirus infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Device related infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Bacterial test positive | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hallucination, visual | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| Title | Measurements |
|---|---|
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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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