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Clinical trials for Ledipasvir

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    31 result(s) found for: Ledipasvir. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2016-000318-31 Sponsor Protocol Number: HepNed-001 Start Date*: 2016-03-09
    Sponsor Name:Erasmus MC
    Full Title: Ledipasvir and sofosbuvir for 8 weeks for the treatment of chronic hepatitis C genotype 4 in patients without cirrhosis. HepNed-001 study
    Medical condition: Hepatitis C
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-002607-33 Sponsor Protocol Number: ANRSHC31SOFTRIH Start Date*: 2014-02-17
    Sponsor Name:INSERM-ANRS
    Full Title: Pilot study to assess efficacy and safety of Sofosbuvir/Ledipasvir (GS-5885) fixed-dose combination with Ribavirin in NS3/4A protease inhibitor-experienced subjects with HCV genotype 1 infection an...
    Medical condition: Coinfection with HCV genotype 1 and HIV
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: View results
    EudraCT Number: 2014-005589-31 Sponsor Protocol Number: 44-2015 Start Date*: 2015-03-25
    Sponsor Name:Department of infectious Diseases, Odense University Hospital
    Full Title: 4 Week treatment for Injecting Drug Users with chronic hepatitis C A phase 4, post marketing randomized clinical open label trial comparing 4 weeks of Ledipasvir/Sofosbuvir (co-formulated) and Ri...
    Medical condition: Chronic Hepatitis C in patients with no or minimal liver fibrosis
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-002401-10 Sponsor Protocol Number: TAL2015 Start Date*: 2015-10-12
    Sponsor Name:FONDAZIONE CASA SOLLIEVO DELLA SOFFERENZA OPERA DI SAN PIO DA PIETRELCINA OSPEDALE IRCCS
    Full Title: Pilot multicenter open label study on treatment with Sofosbuvir/Ledipasvir FDC for patients with thalassemia major and HCV infection.
    Medical condition: Patients with thalassemia major and HCV infection either naïve or on nucleo(s)tide analogs treatment, data on Sofosbuvir-based treatment are currently lacking, while, due to the long infection dura...
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-000690-13 Sponsor Protocol Number: GS-US-337-1463 Start Date*: 2015-04-17
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3b, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults with Chronic HCV Infection.
    Medical condition: Chronic Hepatitis C Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004848 10019751 Hepatitis C virus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed)
    Trial results: View results
    EudraCT Number: 2013-001081-42 Sponsor Protocol Number: HepNet-aHCV-IV Start Date*: 2014-10-21
    Sponsor Name:Hannover Medical School
    Full Title: Interferon-free Treatment of Acute Genotype 1 Hepatitis C Virus Infection with Ledipasvir/Sofosbuvir Fixed-Dose Combination - The HepNet Acute HCV IV Study
    Medical condition: Adults with acute genotype 1 hepatitis C virus (HCV) infection
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004848 10072848 Hepatitis C virus genotype 1 positive LLT
    18.1 10021881 - Infections and infestations 10065051 Acute hepatitis C PT
    18.1 100000004848 10019752 Hepatitis C virus (HCV) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-005081-60 Sponsor Protocol Number: RENAL-AAD Start Date*: 2017-04-21
    Sponsor Name:Jose Luis Calleja Panero
    Full Title: MULTICENTER CLINICAL TRIAL TO DETERMINE THE INFLUENCE OF TREATMENT WITH DIRECT ANTIVIRAL AGENTS IN THE GLOMERULAR AND TUBULAR FUNCTION OF PATIENTS WITH CHRONIC HCV HEPATITIS
    Medical condition: Hepatitis C
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-004830-81 Sponsor Protocol Number: FIL_BArT Start Date*: 2015-12-24
    Sponsor Name:FONDAZIONE ITALIANA LINFOMI ONLUS
    Full Title: A multicenter study to evaluate the anti-viral activity of an interferon-free treatment with ledipasvir/sofosbuvir (G1 and G4) and sofosbuvir/velpatasvir (G2 and G3) for patients with hepatitis C v...
    Medical condition: Patients with hepatitis C virus-associated indolent B-cell lymphomas
    Disease: Version SOC Term Classification Code Term Level
    23.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065856 Non-Hodgkin's lymphoma unspecified histology indolent PT
    20.1 10021881 - Infections and infestations 10065051 Acute hepatitis C PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-002958-21 Sponsor Protocol Number: HCV-art Start Date*: 2017-05-16
    Sponsor Name:AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI
    Full Title: Study HCV-art: An Open-Label, pilot Study, to Explore the Clinical Safety and Efficacy of Sofosbuvir/Ledipasvir in Hepatitis C Virus (HCV) Chronic Patients with Arthritis
    Medical condition: Chronic HCV associated with chronic arthritis.
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004859 10066550 Chronic arthritis LLT
    20.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-000459-25 Sponsor Protocol Number: TMC435HPC2017 Start Date*: 2015-05-12
    Sponsor Name:Janssen Sciences Ireland UC
    Full Title: A Phase 2, 2-panel, Open-label, Randomized Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir, and L...
    Medical condition: Chronic Hepatitus C Virus (HCV) Genotype 1 Infection
    Disease: Version SOC Term Classification Code Term Level
    18.0 10021881 - Infections and infestations 10019744 Hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-004812-12 Sponsor Protocol Number: GS-US-337-1612 Start Date*: 2015-05-07
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Subjects with Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and C...
    Medical condition: Acute Genotype 1 or Genotype 4 Hepatitis C Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    18.0 10022891 - Investigations 10070218 Hepatitis C virus test positive PT
    18.0 10022891 - Investigations 10019751 Hepatitis C virus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-003741-42 Sponsor Protocol Number: GS-US-337-1904 Start Date*: 2018-10-24
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Open-label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Subjects Underg...
    Medical condition: Hepatitis C Virus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10019744 Hepatitis C PT
    20.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-003570-32 Sponsor Protocol Number: GS-US-337-1115 Start Date*: 2015-08-14
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 1 Relative Bioavailability and Food Effect Study of a Pediatric Granules Formulation of Ledipasvir/Sofosbuvir in Healthy Adult Subjects
    Medical condition: Chronic Hepatitis C virus infection
    Disease: Version SOC Term Classification Code Term Level
    18.0 10021881 - Infections and infestations 10019744 Hepatitis C PT
    18.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-003978-27 Sponsor Protocol Number: GS-US-337-1119 Start Date*: 2014-02-20
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naïve and Treatment-Experienced Subjects with Chronic Ge...
    Medical condition: Chronic Genotype 4 and Genotype 5 Hepatitis C Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004848 10019751 Hepatitis C virus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-003956-22 Sponsor Protocol Number: GS-US-337-2091 Start Date*: 2017-09-29
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 1 Relative Bioavailability and Food Effect Study of a Pediatric Oral Granule Formulation of Ledipasvir/Sofosbuvir in Healthy Adult Subjects
    Medical condition: Chronic Hepatitis C virus infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10019744 Hepatitis C PT
    20.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-001245-24 Sponsor Protocol Number: GS-US-337-1118 Start Date*: 2014-10-01
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: An open-Label, multicenter study to evaluate the efficacy and safety of sofosbuvir/ledipasvir fixed-dose combination ± ribavirin for 12 or 24 weeks in chronic genotype 1 HCV infected subjects who p...
    Medical condition: Chronic Genotype 1 Hepatitis C Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004848 10019751 Hepatitis C virus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2013-002296-17 Sponsor Protocol Number: GS-US-337-0121 Start Date*: 2013-09-02
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks with Ribavirin or for ...
    Medical condition: Chronic Genotype 1 Hepatitis C Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004848 10019751 Hepatitis C virus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-002121-35 Sponsor Protocol Number: GS-US-337-1406 Start Date*: 2014-10-29
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Open Label Study to Evaluate The Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination (FDC) Tablet for 12 or 24 Weeks in Kidney Transplant Recipients with Chroni...
    Medical condition: Chronic Genotype 1 and Genotype 4 Hepatitis C Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004848 10019751 Hepatitis C virus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2016-003489-25 Sponsor Protocol Number: GS-US-337-4063 Start Date*: 2017-03-27
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Ledipasvir/Sofosbuvir in Subjects with Genotype 1, 4, 5 and 6 Chronic HCV Infection Who are on Dialysis for End Stage...
    Medical condition: Chronic Hepatitis C virus infection
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10019744 Hepatitis C PT
    19.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-003578-17 Sponsor Protocol Number: GS-US-337-1116 Start Date*: 2015-01-28
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination in Adolescents and Children with Chronic HCV-Infection
    Medical condition: Chronic Hepatitis C virus infection
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10019744 Hepatitis C PT
    17.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA GB (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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