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Clinical trials for Glecaprevir

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   44334   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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    12 result(s) found for: Glecaprevir. Displaying page 1 of 1.
    EudraCT Number: 2016-004967-38 Sponsor Protocol Number: M16-135 Start Date*: 2017-08-01
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults with Chronic Hepatitis C Virus (HCV) Genotype 1, 2, 4, 5 or 6 In...
    Medical condition: HCV
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004848 10019752 Hepatitis C virus (HCV) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) PL (Completed) PT (Completed) HU (Completed) CZ (Completed) BG (Completed) IE (Completed) ES (Completed) GB (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2019-003736-22 Sponsor Protocol Number: M17-142 Start Date*: 2020-07-08
    Sponsor Name:AbbVie Inc.
    Full Title: Bioavailability and Food Effect of Experimental Glecaprevir + Pibrentasvir Pediatric Formulation in Healthy Adult Subjects
    Medical condition: Hepatitis C virus (HCV) infection
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-002221-37 Sponsor Protocol Number: PA-IT72-2012 Start Date*: 2018-11-12
    Sponsor Name:AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO “PAOLO GIACCONE” DI PALERMO
    Full Title: Glecaprevir/ pibrentasvir plus fixed-dose combination for 6 weeks in patients with acute hepatitis C virus: a pilot study.
    Medical condition: Acute HCV infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10047457 Viral hepatitis C LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-004182-60 Sponsor Protocol Number: M16-127 Start Date*: 2017-05-08
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Multicenter, Open-Label, Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Renally-Impaired Adults with Chronic Hepatitis C Virus Genotype 1 – 6 Infection
    Medical condition: HCV
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000074171 10019752 Hepatitis C virus (HCV) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) ES (Completed) DE (Completed) PL (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-004102-34 Sponsor Protocol Number: M16-123 Start Date*: 2017-08-25
    Sponsor Name:AbbVie Deutschland GmbH & Co.KG
    Full Title: An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects with Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection
    Medical condition: Chronic Hepatitis C Infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004848 10019752 Hepatitis C virus (HCV) LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) BE (Completed) DE (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2016-004876-23 Sponsor Protocol Number: M16-133 Start Date*: 2017-09-13
    Sponsor Name:AbbVie Deutschland
    Full Title: A Single Arm, Open Label, Multicenter Study to Evaluate the Efficacy and Safety of Glecaprevir(GLE)/Pibrentasvir(PIB) in Treatment Naïve Adults with Chronic Hepatitis C Virus (HCV) Genotypes 1 – 6 ...
    Medical condition: Chronic Hepatitis C infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000074171 10019751 Hepatitis C virus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) DE (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-003192-22 Sponsor Protocol Number: M16-126 Start Date*: 2017-03-08
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Adults with Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection.
    Medical condition: Chronic hepatitis C virus genotype 5 or 6 infection, cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000074171 10019752 Hepatitis C virus (HCV) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2017-000694-37 Sponsor Protocol Number: VHCRP1701 Start Date*: 2017-11-23
    Sponsor Name:University of New South Wales Sydney
    Full Title: A phase IIIb, open-label, multicentre, international randomised controlled trial of simplified treatment monitoring for 8 weeks glecaprevir (300mg)/pibrentasvir (120mg) in chronic HCV treatment naï...
    Medical condition: Chronic hepatitis C virus 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) FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-005179-21 Sponsor Protocol Number: 4RIBC-2018 Start Date*: 2018-03-09
    Sponsor Name:Department of infectious Diseases, Odense University Hospital
    Full Title: Four weeks treatment for chronic hepatitis C in patients under 50 years of age with no significant liver fibrosis
    Medical condition: Chronic Hepatitis C
    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: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-005777-27 Sponsor Protocol Number: M20-350 Start Date*: 2021-07-22
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Multicenter, Single-Arm Prospective Study to Evaluate Safety and Efficacy of GLE/PIB 8-Week Treatment in Adults and Adolescents with Acute Hepatitis C Virus (HCV) Infection
    Medical condition: Hepatitis C Virus
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Ongoing) AT (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002008-28 Sponsor Protocol Number: 2017-002008-28 Start Date*: 2017-12-21
    Sponsor Name:Region Skåne
    Full Title: A prospective open label study to evaluate treatment of chronic HCV infection with glecaprevir/pibrentasvir in PWID attending a needle exchange program
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10019744 Hepatitis C PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-005004-28 Sponsor Protocol Number: 15SM3025 Start Date*: 2015-12-31
    Sponsor Name:Imperial College London
    Full Title: Stratified Treatment OPtimisation for HCV-1 (STOPHCV-1)
    Medical condition: Hepatitis C Infection (HCV) (genotype 1a/1b/4)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: 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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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