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Clinical trials for Sofosbuvir

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44336   clinical trials with a EudraCT protocol, of which   7366   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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    88 result(s) found for: Sofosbuvir. Displaying page 1 of 5.
    1  2  3  4  5  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: 2016-000599-87 Sponsor Protocol Number: 011094 Start Date*: 2016-06-01
    Sponsor Name:Queen Mary University of London
    Full Title: Response guided therapy with daclatasvir, sofosbuvir and ribavirin for 12 or 24 weeks in patients with genotype 3 chronic hepatitis C virus: is longer therapy worthwhile?
    Medical condition: Adult patients chronically infected with genotype 3 hepatitis C virus with cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-002272-24 Sponsor Protocol Number: M13-594 Start Date*: 2016-01-26
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Randomized, Open-Label, Active-Controlled, Multicenter Study to Compare Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Co-Administered with Daclatasvir in Adults with Chronic Hepatitis C Vi...
    Medical condition: Chronic HCV Genotype 3 Infection
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2020-003879-18 Sponsor Protocol Number: SOF-VEL/PED/2020 Start Date*: 2021-04-21
    Sponsor Name:Medical University of Warsaw
    Full Title: Treatment of chronic hepatitis C in children aged 6 – 18 years using a pangenotypic direct-acting antiviral (sofosbuvir/velpatasvir)
    Medical condition: Chronic hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10019744 Hepatitis C PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-003147-35 Sponsor Protocol Number: M14-567 Start Date*: 2014-12-16
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of the Co-Administration of Ombitasvir/ABT-450/Ritonavir (Ombitasvir/ABT-450/r) With Sofosbuvir (SOF) With or Without Ribavirin (R...
    Medical condition: Chronic Hepatitis C Virus (HCV) Infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-002317-32 Sponsor Protocol Number: SOFOLT-2 Start Date*: 2014-10-29
    Sponsor Name:Azienda Ospedaliera Papa Giovanni XXIII [...]
    1. Azienda Ospedaliera Papa Giovanni XXIII
    2. AISF (Associazione Italiana per lo Studio del Fegato)
    Full Title: An Open-Label Study to Explore the Clinical Efficacy of GS 7977 (Sofosbuvir -Sovaldi®) with Ribavirin as Pre-Emptive Administration in Transplant-Recipients with Hepatitis C Virus (HCV) active infe...
    Medical condition: HCV active infection at the time of OLT
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-002808-25 Sponsor Protocol Number: AI444-281 Start Date*: 2015-04-16
    Sponsor Name:Academic Medical Center Amsterdam
    Full Title: Immune phenotyping in chronic hepatitis C patients treated with Sofosbuvir and Daclatasvir combination with or without Ribavirin for 12 or 24 weeks -SODA study
    Medical condition: Chronic hepatitis C
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (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: 2015-004830-81 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: 2014-004674-42 Sponsor Protocol Number: GS-US-334-1113 Start Date*: 2015-11-20
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Long Term Follow-up Registry for Adolescent and Pediatric Subjects Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials
    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
    20.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) BE (Completed) PL (Completed) IT (Completed)
    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: 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: 2014-005388-34 Sponsor Protocol Number: SOF Start Date*: 2015-05-20
    Sponsor Name:AZIENDA OSPEDALIERA DI PADOVA
    Full Title: Single arm prospective clinical study to evaluate the efficacy of combination therapy sofosbuvir+ribavirin+peg-interferon in experienced patients with HCV-GT1
    Medical condition: chronic hepatitis HCV GT1 who have already failed a prior course of dual therapy with pegylated interferon + ribavirin
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10057212 Hepatitis viral infections HLT
    19.0 10021881 - Infections and infestations 10019744 Hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-002446-23 Sponsor Protocol Number: GS-US-342-1143 Start Date*: 2017-01-19
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children with Chronic HCV Infection
    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
    20.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) Outside EU/EEA IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-000416-15 Sponsor Protocol Number: GS-US-342-2104 Start Date*: 2016-07-14
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination in Subjects with Chronic HCV Infection who have Received a Liver Transp...
    Medical condition: Chronic Hepatitis C virus infection
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    19.0 10019805 - Hepatobiliary disorders 10019754 Hepatitis cholestatic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-002491-26 Sponsor Protocol Number: M15-942 Start Date*: 2017-03-17
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Combination with Sofosbuvir and Ribavirin in Chronic Hepatitis C (HCV) Infected Subjects Who Have Experien...
    Medical condition: Chronic Hepatitis C Infection
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Completed) ES (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-003387-43 Sponsor Protocol Number: GS-US-337-0102 Start Date*: 2013-01-31
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin for 12 and 24 Weeks in Treatment-Naïve Subjects ...
    Medical condition: Chronic Genotype 1 Hepatitis C Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004848 10019751 Hepatitis C virus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-001249-26 Sponsor Protocol Number: GS-US-337-1431 Start Date*: 2016-02-12
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Registry for Subjects with Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment with a Sofosbuvir-Based Regimen without Interferon for Chronic Hepatitis C Infection in Gilead-...
    Medical condition: 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 10021881 Infections and infestations SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-001956-31 Sponsor Protocol Number: 2015-001956-31 Start Date*: 2015-06-09
    Sponsor Name:Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre.
    Full Title: Direct acting antiviral therapy of hepatitis C in Denmark: treatment response, adverse events and resistance associated variants
    Medical condition: Patients with chronic hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10074391 Chronic hepatitis C virus genotype 1 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (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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