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Clinical trials for Elbasvir

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   44335   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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    18 result(s) found for: Elbasvir. Displaying page 1 of 1.
    EudraCT Number: 2015-003210-24 Sponsor Protocol Number: DAHHS2V1.0 Start Date*: 2016-01-07
    Sponsor Name:Erasmus MC
    Full Title: Grazoprevir (MK-5172) + Elbasvir (MK-8742) for the treatment of acute hepatitis C genotype 1/4. The Dutch Acute HCV in HIV Study (DAHHS-2)
    Medical condition: Acute Hepatitis C in HIV infected patients
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-001536-36 Sponsor Protocol Number: EARLY-HEP-C Start Date*: 2016-08-03
    Sponsor Name:Fundació Clínic per a la Recerca Biomèdica
    Full Title: Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV co-infected patients
    Medical condition: Early Chronic Hepatitis C in HIV/HCV co-infected patients
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10065949 HCV coinfection LLT
    19.0 100000004862 10068341 HIV-1 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-001363-37 Sponsor Protocol Number: RBHP_2016_ABERGEL Start Date*: 2016-11-18
    Sponsor Name:CHU de Clermont-Ferrand
    Full Title: A Phase 3, Global, Multicenter, Open-Label Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non-seve...
    Medical condition: viral hepatitis C
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-005453-13 Sponsor Protocol Number: EGRADICATE Start Date*: 2016-08-03
    Sponsor Name:Fundació clínic per a la Recerca Biomèdica
    Full Title: PILOT STUDY TO EVALUATE THE EFFICACY AND TOLERABILITY OF GRAZOPREVIR + ELBASVIR FOR 12 OR 16 WEEKS IN LIVER TRANSPLANT RECIPIENTS
    Medical condition: HCV infection and liver trasplant
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004848 10019752 Hepatitis C virus (HCV) LLT
    19.0 100000004865 10024716 Liver transplantation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-003006-16 Sponsor Protocol Number: 5172-079 Start Date*: 2017-12-19
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase IIb Clinical Study to Assess the Pharmacokinetics, Safety, and Efficacy of the Combination Regimen of Elbasvir (EBR)/Grazoprevir (GZR) in Participants Aged 3 to less than 18 Years with Chro...
    Medical condition: Chronic genotype 1 or genotype 4 Hepatitis C Virus infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10047457 Viral hepatitis C LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) PL (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-000432-34 Sponsor Protocol Number: GESIDA9516 Start Date*: 2017-05-31
    Sponsor Name:Fundación SEIMC-GESIDA
    Full Title: A PHASE III, OPEN-LABEL, MULTICENTRIC CLINICAL TRIAL OF A SINGLE ARM OF 16 LENGTHS OF TIME TO EVALUATE RETENTION WITH ELBASVIR / GRAZOPREVIR PLUS SOFOSBUVIR AND RIBAVIRIN IN PATIENTS WITH HEPATITIS...
    Medical condition: HCV infection
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-004713-24 Sponsor Protocol Number: GECOMstudy Start Date*: 2016-04-11
    Sponsor Name:IRCCS ISTITUTO CLINICO HUMANITAS
    Full Title: A Multicenter, Open Label, Pilot Study to Investigate Tolerability and Efficacy of MK5172 (Grazoprevir) / MK8742 (Elbasvir) Without Ribavirin for 12 Weeks in Patients With Chronic HCV G1b Infection...
    Medical condition: Chronic infection with Hepatitis C virus genotype 1b with compensated cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004871 10064844 Compensated cirrhosis LLT
    20.0 10021881 - Infections and infestations 10019744 Hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-001159-37 Sponsor Protocol Number: MK-5172-096 Start Date*: 2017-05-02
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Multi-Site, Open-Label, Partially-Randomized Trial of the Efficacy and Safety of Fixed Dose Elbasvir/Grazoprevir (EBR/GZR) Based Regimens in French Subjects with Chronic Hepatitis C Virus (HCV) G...
    Medical condition: Hepatitis C Infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10076826 Chronic hepatitis C genotype 4 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (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: 2018-002251-14 Sponsor Protocol Number: KCHATTIC01 Start Date*: 2019-01-02
    Sponsor Name:Kings College Hospital NHS Foundation Trust
    Full Title: Localized on site testing and treatment of hepatitis C in homeless persons in London: a pilot non-randomised phase 4 interventional clinical trial of grazoprevir and elbasvir ± ribavirin in partici...
    Medical condition: hepatitis C viral infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10008914 Chronic hepatitis C without mention of hepatic coma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-003710-58 Sponsor Protocol Number: 57238 Start Date*: 2018-07-17
    Sponsor Name:AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO “PAOLO GIACCONE” DI PALERMO
    Full Title: Study to Investigate the Efficacy of elbasvir/grazoprevir Fixed-Dose Combination for 8 Weeks in G1b Treatment-Na¿ve, HCV-Infected Patients With non-severe Fibrosis, with or without glucose abnorm...
    Medical condition: chronic hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    20.0 10019805 - Hepatobiliary disorders 10019805 Hepatobiliary disorders SOC
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-001125-13 Sponsor Protocol Number: SAHIV-IMEA50 Start Date*: 2017-04-07
    Sponsor Name:IMEA (Institut de Médecine et d’Epidémiologie Appliquée)–Fondation Léon M’Ba
    Full Title: Pilot study - Short duration therapy of acute hepatitis C genotypes 1 or 4 in HIV-infected patients: efficacy and tolerability of grazoprevir 100mg/elbasvir 50mg during 8 weeks
    Medical condition: Acute hepatitis C (genotypes 1 or 4)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10065051 Acute hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-003187-37 Sponsor Protocol Number: MK-5172-083 Start Date*: 2016-01-25
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) with and without Ribavirin (RBV)...
    Medical condition: Hepatitis C infection
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004848 10019751 Hepatitis C virus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    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: 2015-005577-20 Sponsor Protocol Number: M14-730 Start Date*: 2016-07-12
    Sponsor Name:AbbVie Deutschland GmbH & Co. KG
    Full Title: A Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults with Chronic Hepatitis C Virus (HCV) Genotypes 1-6 Infection and Human Immunodeficiency Virus-1 (HIV...
    Medical condition: Hepatitis C Virus Infection Human Immunodeficiency Virus Infection Chronic Hepatitis C Compensated Cirrhosis and Non-cirrhotics
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-003414-26 Sponsor Protocol Number: ZEP-HEPC-001 Start Date*: 2017-12-12
    Sponsor Name:Dr. John Lambert (Mater Misericordiae University Hospital)
    Full Title: An open label study of the safety and efficacy of FDC Zepatier (elbasvir and grazoprevir +/- Ribavirin) administered in a community-based setting to HCV infected G1/4 treatment naïve patients on ...
    Medical condition: HCV Genotypes 1/4
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: IE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-001039-38 Sponsor Protocol Number: 2016GA03 Start Date*: 2017-09-14
    Sponsor Name:University of Dundee/NHS Tayside
    Full Title: A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment – ADVANCE HCV Study
    Medical condition: Hepatitis C virus infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-000672-25 Sponsor Protocol Number: MK-5172-059 Start Date*: 2014-12-31
    Sponsor Name:Merck Sharp & Dohme Copr., a subsidary of Merck & Co.
    Full Title: A Phase II/III Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects with Chronic Hepatitis C Virus Infection with Advanced Cirrhosis and Chi...
    Medical condition: Hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004848 10019751 Hepatitis C virus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Prematurely Ended) ES (Prematurely Ended) NL (Completed) EE (Completed) PL (Completed) IT (Prematurely Ended) 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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