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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002121-35 | EudraCT Number |
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This study will evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) for 12 or 24 weeks in adults with chronic genotype 1 or genotype 4 hepatitis C virus (HCV) infection who have had a kidney transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDV/SOF 12 wk | Experimental | Participants will receive LDV/SOF FDC for 12 weeks. |
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| LDV/SOF 24 wk | Experimental | Participants will receive LDV/SOF FDC for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDV/SOF | Drug | 90/400 mg FDC tablet administered orally once daily |
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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 Permanently Discontinued Any Study Drug Due to an Adverse Event | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 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 after stopping study treatment, respectively. | Posttreatment Weeks 4 and 24 |
| 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 |
|---|---|---|---|---|---|---|
| Vienna | Austria | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Colombo M, Aghemo A, Liu H, Dvory-Sobol H, Hyland RH, Yun C, Brainard DM, McHutchison JG, Bourliere M, Peck-Radosavljevic M, Manns M, Pol S. Ledipasvir/Sofosbuvir (LDV/SOF) for 12 or 24 Weeks Is Safe and Effective in Kidney Transplant Recipients With Chronic Genotype 1 or 4 HCV Infection. Journal of Hepatology. 2016;64 pp S183-S212. (GS 13, oral presentation). | ||
| 27842383 | Result | Colombo M, Aghemo A, Liu H, Zhang J, Dvory-Sobol H, Hyland R, Yun C, Massetto B, Brainard DM, McHutchison JG, Bourliere M, Peck-Radosavljevic M, Manns M, Pol S. Treatment With Ledipasvir-Sofosbuvir for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 or 4 Infection: A Randomized Trial. Ann Intern Med. 2017 Jan 17;166(2):109-117. doi: 10.7326/M16-1205. Epub 2016 Nov 15. |
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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.
130 participants were screened.
Participants were enrolled at study sites in Europe. The first participant was screened on 14 October 2014. The last study visit occurred on 16 June 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | LDV/SOF 12 Weeks | Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) for 12 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant |
| FG001 | LDV/SOF 24 Weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Virologic failure was defined as:
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| Up to Posttreatment Week 24 |
| Marseille |
| France |
| Paris | France |
| Hanover | Germany |
| Milan | Italy |
LDV/SOF (90/400 mg) for 24 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant
| 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 12 Weeks | LDV/SOF (90/400 mg) for 12 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant |
| BG001 | LDV/SOF 24 Weeks | LDV/SOF (90/400 mg) for 24 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant |
| BG002 | 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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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 |
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| Years From Most Recent Kidney Transplant | Mean | Standard Deviation | years |
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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 Status | 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 randomized into the 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 Permanently Discontinued Any Study Drug Due to an Adverse Event | Safety Analysis Set: participants who received at least 1 dose of study drug | Posted | Number | percentage of participants | Up to 24 weeks |
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| Secondary | Percentage of Participants With 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 after stopping study treatment, respectively. | Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug | Posted | Number | 95% Confidence Interval | percentage of participants | Posttreatment Weeks 4 and 24 |
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| Secondary | Percentage of Participants With Virologic Failure | Virologic failure was defined as:
| Full Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug | Posted | Number | percentage of participants | Up to Posttreatment Week 24 |
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Up to 24 weeks plus 30 days
Safety Analysis Set: participants who 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 12 Weeks | LDV/SOF (90/400 mg) for 12 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant | 0 | 57 | 5 | 57 | 23 | 57 |
| EG001 | LDV/SOF 24 Weeks | LDV/SOF (90/400 mg) for 24 weeks in participants with chronic genotype 1 or 4 HCV infection who have had a kidney transplant | 0 | 57 | 8 | 57 | 36 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Shunt thrombosis | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 19.0 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA 19.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 19.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Arteriovenous shunt operation | Surgical and medical procedures | MedDRA 19.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 19.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 19.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 19.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA 19.0 | 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 |
| 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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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| White |
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| Asian |
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| Other |
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| Italy |
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| France |
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| Germany |
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| Genotype 4 |
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| Yes |
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| CT |
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| TT |
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| ≥ 800,000 IU/mL |
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| Treatment-Experienced |
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