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This study will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 hepatitis C virus (HCV) infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDV/SOF+RBV | Experimental | LDV/SOF FDC plus RBV for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDV/SOF | Drug | 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 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 12 weeks |
| 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 at Weeks 1, 2, 4, 8 and 12 |
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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 |
|---|---|---|---|---|---|---|
| Calgary | Alberta | T2N 4Z6 | Canada | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Feld JJ, Ramji A, Shafran S, Willems B, Marotta P, Huchet E, et al. Ledipasvir/Sofosbuvir with ribavirin for 12 Weeks is effective and safe in treatment-naïve genotype 3 HCV-infected patients in Canada [Abstract SAT-183]. Presented at: The 51st Annual Congress of the European Association for the Study of Liver: The International Liver Congress (EASL); 2016 April 13-17; Barcelona, Spain. | ||
| 28535298 | Derived | Feld JJ, Ramji A, Shafran SD, Willems B, Marotta P, Huchet E, Vachon ML, Svarovskaia ES, Huang KC, Hyland RH, Yun C, Massetto B, Brainard DM, McHutchison JG, Tam E, Bailey R, Cooper C, Yoshida EM, Greenbloom S, Elkhashab M, Borgia S, Swain MG. Ledipasvir-Sofosbuvir Plus Ribavirin in Treatment-Naive Patients With Hepatitis C Virus Genotype 3 Infection: An Open-Label Study. Clin Infect Dis. 2017 Jul 1;65(1):13-19. doi: 10.1093/cid/cix289. |
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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.
127 participants were screened.
Participants were enrolled at study sites in Canada. The first participant was screened on 15 April 2015. The last study visit occurred on 08 January 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | LDV/SOF+RBV | Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| RBV | Drug | 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) |
|
| Weeks 1, 2, 4, 8, and 12 |
| Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 | Baseline; Weeks 1, 2, 4, 8, and 12 |
| Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| Up to Posttreatment Week 12 |
| Edmonton |
| Alberta |
| T5H 4B9 |
| Canada |
| Edmonton | Alberta | T6G 2B7 | Canada |
| Vancouver | British Columbia | V5Z 1H2 | Canada |
| Vancouver | British Columbia | V5Z 1M9 | Canada |
| Vancouver | British Columbia | V6Z 2K5 | Canada |
| Brampton | Ontario | L6R 3J7 | Canada |
| London | Ontario | N6A 5A5 | Canada |
| Ottawa | Ontario | K1H 8L6 | Canada |
| Toronto | Ontario | M5T 2S8 | Canada |
| Toronto | Ontario | M6H 3M1 | Canada |
| Vaughan | Ontario | L4L 4Y7 | Canada |
| Montreal | Quebec | H2L 4P9 | Canada |
| Montreal | Quebec | H2X 0A9 | Canada |
| Québec | G1V 4G2 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set: all enrolled participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | LDV/SOF+RBV | LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks |
| 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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| Cirrhosis Status | 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 |
| ||||||||||||||||||||||
| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
| ||||||||||||||||||||||
| HCV RNA Category | 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: all enrolled participants who 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 Permanently Discontinued Any Study Drug Due to an Adverse Event | Safety Analysis Set | Posted | Number | percentage of participants | Up to 12 weeks |
|
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| 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 |
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| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Number | 95% Confidence Interval | percentage of participants | Weeks 1, 2, 4, 8, and 12 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12 | Participants in the Full Analysis Set with available data were analyzed. | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline; Weeks 1, 2, 4, 8, and 12 |
|
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| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| Full Analysis Set | Posted | Number | percentage of participants | Up to Posttreatment Week 12 |
|
|
Baseline to 30 days after last dose of study drug (up to 12 weeks plus 30 days)
Safety Analysis Set
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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+RBV | LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks | 4 | 111 | 89 | 111 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
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| Homicidal ideation | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | 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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| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Dizziness | 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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| Depression | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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| Irritability | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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| Cough | 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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| Dyspnoea exertional | Respiratory, thoracic and mediastinal 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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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 |
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| 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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| Genotype 3b |
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| Missing |
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| TT |
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| Missing |
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| Categories |
|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title |
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| Denominators |
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| Categories |
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| Week 1 |
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| Week 2 |
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| Week 4 |
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| Week 8 |
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| Week 12 |
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| Denominators |
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| Categories |
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| Change at Week 1 |
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| Change at Week 2 |
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| Change at Week 4 |
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| Change at Week 8 |
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| Change at Week 12 |
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