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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-001245-24 | EudraCT Number |
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The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve sustained virologic response (SVR24), defined as HCV RNA < lower limit of quantification (LLOQ) 24 weeks after last dose of study drug (SVR24).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDV/SOF+RBV 12 weeks (Group 1) | Experimental | Participants who failed a prior SOF+RBV ± pegylated interferon (Peg-IFN) regimen will receive LDV/SOF FDC plus RBV for 12 weeks. |
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| LDV/SOF 24 weeks (Group 2) | Experimental | Participants who failed a prior LDV/SOF ± RBV regimen will receive LDV/SOF FDC for 24 weeks. |
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| LDV/SOF+RBV 24 weeks (Group 3) | Experimental | Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen will receive LDV/SOF FDC plus RBV for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDV/SOF | Drug | Tablet(s) administered orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment. | Post-treatment Week 12 |
| Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event | Up to 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively. | Posttreatment Weeks 4 and 24 |
| Percentage of Participants With HCV RNA < LLOQ While 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 |
|---|---|---|---|---|---|---|
| Beverly Hills | California | 90210 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Lawitz E, Pockros PJ, Yang JC, Pang PS, Zhu Y, Svarovskaia E, et al. Ledipasvir/sofosbuvir regimens for the retreatment of patients who failed sofosbuvir-based regimens [Abstract 10868]. Presented at: The 25th Conference of the Asian Pacific Association for the Study of Liver (APASL); 2016 February 20-24; Tokyo, Japan. | ||
| Background | Lawitz E, Flamm S, Yang JC, Pang PS, Zhu Y, Svarovskaia E, et al. Retreatment of patients who failed 8 or 12 weeks of ledipasvir/sofosbuvir-based regimens with ledipasvir/sofosbuvir for 24 weeks [Abstract 1627]. Presented at: The 50th Annual Congress of the European Association for the Study of Liver: The International Liver Congress (EASL); 2015 April 22-26; Vienna, Austria | ||
| 25846014 | Result | Wyles D, Pockros P, Morelli G, Younes Z, Svarovskaia E, Yang JC, Pang PS, Zhu Y, McHutchison JG, Flamm S, Lawitz E. Ledipasvir-sofosbuvir plus ribavirin for patients with genotype 1 hepatitis C virus previously treated in clinical trials of sofosbuvir regimens. Hepatology. 2015 Jun;61(6):1793-7. doi: 10.1002/hep.27814. Epub 2015 Apr 27. |
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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.
101 participants were screened.
Participants were enrolled at study sites in the US, Australia, and Spain. The first participant was screened on 30 July 2014. The last study visit occurred on 12 November 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | LDV/SOF + RBV 12 Weeks (Group 1) | Participants who failed a prior sofosbuvir (SOF) + ribavirin (RBV) ± pegylated interferon (Peg-IFN) regimen received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally 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) Participants in the LDV/SOF+RBV 24 weeks group will dose adjust RBV according to hemoglobin and renal status as stated in the RBV package insert. |
|
| Baseline to Week 24 |
| Change in HCV RNA From Baseline | Baseline to Week 8 |
| Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| Up to posttreatment Week 24 |
| La Jolla |
| California |
| 92037 |
| United States |
| Los Angeles | California | 90027 | United States |
| Los Angeles | California | 90036 | United States |
| Los Angeles | California | 90069 | United States |
| Oceanside | California | 92056 | United States |
| San Diego | California | 92103 | United States |
| San Francisco | California | 94115 | United States |
| Aurora | Colorado | 80045 | United States |
| Washington D.C. | District of Columbia | 20009 | United States |
| Gainesville | Florida | 32610 | United States |
| Jacksonville | Florida | 32256 | United States |
| Miami | Florida | 33136 | United States |
| Orlando | Florida | 32803 | United States |
| Wellington | Florida | 33414 | United States |
| Marietta | Georgia | 30060 | United States |
| Chicago | Illinois | 60611 | United States |
| Downers Grove | Illinois | 60515 | United States |
| Indianapolis | Indiana | 46237 | United States |
| Bowling Green | Kentucky | 42101 | United States |
| Baton Rouge | Louisiana | 70809 | United States |
| Baltimore | Maryland | 21229 | United States |
| Boston | Massachusetts | 02215 | United States |
| Springfield | Massachusetts | 01105 | United States |
| Minneapolis | Minnesota | 55414 | United States |
| Kansas City | Missouri | 64131 | United States |
| Hillsborough | New Jersey | 08844 | United States |
| Albuquerque | New Mexico | 87131 | United States |
| Binghamton | New York | 13903 | United States |
| Manhasset | New York | 11030 | United States |
| New York | New York | 10029 | United States |
| Asheville | North Carolina | 28801 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Philadelphia | Pennsylvania | 19104 | United States |
| Germantown | Tennessee | 38138 | United States |
| San Antonio | Texas | 78215 | United States |
| Norfolk | Virginia | 23502 | United States |
| Richmond | Virginia | 23226 | United States |
| Seattle | Washington | 98111 | United States |
| Camperdown | New South Wales | 2050 | Australia |
| Clichy | 92110 | France |
| San Juan | 00927 | Puerto Rico |
| Barcelona | 08028 | Spain |
| FG001 |
| LDV/SOF 24 Weeks (Group 2) |
Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks |
| FG002 | LDV/SOF + RBV 24 Weeks (Group 3) | Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set: participants who received at least 1 dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | LDV/SOF + RBV 12 Weeks (Group 1) | Participants who failed a prior SOF+RBV ± Peg-IFN regimen received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks |
| BG001 | LDV/SOF 24 Weeks (Group 2) | Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks |
| BG002 | LDV/SOF + RBV 24 Weeks (Group 3) | Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Region of Enrollment | Number | participants |
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| Prior HCV Treatment Experience | Number | Particiapants |
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| IL28B | The CC, CT, and TT alleles are different forms of the IL28b gene. | Number | Participants |
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| HCV RNA | Mean | Standard Deviation | log10 IU/mL |
| |||||||||||||||
| HCV RNA Category | Number | 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 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment. | Full Analysis Set: participants enrolled into the study and received at least 1 dose of study drug | Posted | Number | Percentage of participants | Post-treatment 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 24 Weeks |
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| Secondary | Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively. | Full Analysis Set | Posted | Number | Percentage of participants | Posttreatment Weeks 4 and 24 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With HCV RNA < LLOQ While on Treatment | Full Analysis Set | Posted | Number | Percentage of participants | Baseline to Week 24 |
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| Secondary | Change in HCV RNA From Baseline | Full Analysis Set | Posted | Mean | Standard Deviation | log10 IU/mL | Baseline to Week 8 |
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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 24 |
|
Up to 24 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 12 Weeks (Group 1) | Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks | 2 | 51 | 37 | 51 | ||
| EG001 | LDV/SOF 24 Week (Group 2) | Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks | 2 | 41 | 16 | 41 | ||
| EG002 | LDV/SOF + RBV 24 Week (Group 3) | Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks | 2 | 8 | 7 | 8 |
| 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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| Chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis infective | Infections and infestations | 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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| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
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| Bipolar disorder | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
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| Oedema genital | Reproductive system and breast 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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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Ascites | 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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| Dysphagia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Oesophagitis | 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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| Oedema | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | 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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| Viral infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Haemoglobin 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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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Encephalopathy | 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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| 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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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
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There were no limitations affecting the analysis or results.
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 |
| 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 |
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| ID | Term |
|---|---|
| C000595958 | ledipasvir, sofosbuvir drug combination |
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| Male |
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| White |
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| Not Hispanic or Latino |
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| Australia |
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| Spain |
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| SOF+RBV |
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| LDV/SOF |
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| LDV/SOF+RBV |
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| LDV/SOF+GS-9669 |
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| Without SOF |
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| CT |
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| TT |
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| >= 800,000 IU/mL |
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| Units | Counts |
|---|---|
| Participants |
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