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Clinical trials for Direct-acting antivirals

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    19 result(s) found for: Direct-acting antivirals. Displaying page 1 of 1.
    EudraCT Number: 2012-005636-29 Sponsor Protocol Number: IDX-03YF Start Date*: 2013-05-17
    Sponsor Name:Idenix Pharmaceuticals, Inc.
    Full Title: 3-Year, Observational Study to Evaluate the Durability of Sustained Viral Response and the Kinetics of Antiviral-Resistant HCV in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Act...
    Medical condition: Chronic Hepatitis C Infection
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-006132-24 Sponsor Protocol Number: CDEB025A2313 Start Date*: 2012-05-18
    Sponsor Name:Novartis Farmaceutica, S.A.
    Full Title: A multi-centre 3-year follow-up study to assess the viral activity in patients who failed to achieve sustained virologic response in Novartis-sponsored alisporivir studies for chronic hepatitis C p...
    Medical condition: Chronic hepatitis C patients who failed to achieve sustained virologic response (SVR24) on alisporivir or direct-acting antivirals (DAA) in previous Novartis-sponsored studies.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) HU (Prematurely Ended) GB (Completed) PL (Prematurely Ended) IT (Prematurely Ended) DE (Completed)
    Trial results: View results
    EudraCT Number: 2005-000728-18 Sponsor Protocol Number: VT002 Start Date*: 2005-02-21
    Sponsor Name:AISAR ASSOCIAZIONE ITALIANA PER LO STUDIO DEGLI ANTIMICROBICI E DELLE RESISTENZE
    Full Title: An experiment of phase II open label about safety and Mifepristone vgx-410 anti-HIV activity on patients affected by HIV-1
    Medical condition: Anti-HIV drug
    Disease: Version SOC Term Classification Code Term Level
    10000807 PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    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
    EudraCT Number: 2016-002845-46 Sponsor Protocol Number: AL-335-604 Start Date*: 2017-02-03
    Sponsor Name:Alios BioPharma, Inc.
    Full Title: A Phase 2a, Open-Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335 and Odalasvir, with or without Simeprevir, in Treatment-Naïve Subjects with Genotype ...
    Medical condition: Chronic Hepatitis C infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10076789 Chronic hepatitis C genotype 2 LLT
    20.0 100000004862 10076831 Chronic hepatitis C genotype 3 LLT
    20.0 100000004862 10076786 Chronic hepatitis C genotype 1 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-005293-31 Sponsor Protocol Number: AI452-016 Start Date*: 2012-06-01
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Long-Term Follow-Up Study of Subjects Who Participated in a Clinical Trial in which Peginterferon Lambda-1a (BMS-914143) was Administered for the Treatment of Chronic Hepatitis C Revised Proto...
    Medical condition: Chronic Hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) ES (Completed) PL (Completed) IT (Completed) GR (Completed) FI (Completed) BE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2011-004237-14 Sponsor Protocol Number: AI444-052 Start Date*: 2012-02-09
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3 Evaluation of BMS-790052 (Daclatasvir) Compared with Telaprevir in Combination with Peg-Interferon Alfa-2a and Ribavirin in Treatment-Naive Patients with Chronic Hepatitis-C Revised Prot...
    Medical condition: Chronic Hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) ES (Completed) GB (Completed) IT (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2013-004043-23 Sponsor Protocol Number: IDX-04B-001 Start Date*: 2013-11-13
    Sponsor Name:Idenix Pharmaceuticals Inc.
    Full Title: A Phase I/IIa Study Assessing Single and Multiple Doses of IDX21437 in Healthy and HCV-Infected Subjects
    Medical condition: Hepatitis C virus
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004848 10019751 Hepatitis C virus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2009-018197-66 Sponsor Protocol Number: 1241.21 Start Date*: 2010-04-29
    Sponsor Name:Unilfarma, Lda.
    Full Title: Safety, antiviral effect and pharmacokinetics of BI 207127 in combination with BI 201335 and with or without ribavirin for 4, 16, 24, 28 or 40 weeks in patients with chronic HCV genotype 1 infectio...
    Medical condition: chronic hepatitis C infection of genotype 1
    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: PT (Completed) FR (Completed) DE (Completed) AT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-003528-62 Sponsor Protocol Number: EDP305-201 Start Date*: 2018-12-05
    Sponsor Name:Enanta Pharmaceuticals, Inc.
    Full Title: A Phase 2 Dose Ranging, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects with Primary Biliary Cholangitis...
    Medical condition: Primary Biliary Cholangitis (PBC)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004871 10036680 Primary biliary cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) BE (Completed) ES (Completed) AT (Completed) NL (Completed)
    Trial results: View results
    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
    EudraCT Number: 2010-024557-36 Sponsor Protocol Number: VHCRP1007 Start Date*: 2012-05-29
    Sponsor Name:The Kirby Institute
    Full Title: A phase IV open-label multicentre, international trial of response guided treatment with directly observed pegylated interferon alfa 2b and self-administered ribavirin for patients with chronic HCV...
    Medical condition: Chronic Hepatitis C genotype 2 and 3 infection.
    Disease: Version SOC Term Classification Code Term Level
    18.0 10021881 - Infections and infestations 10008912 Chronic hepatitis C PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2004-003865-33 Sponsor Protocol Number: CCR100136 Start Date*: 2005-02-03
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A Phase IIb, 96 week, randomized, open-label, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of different doses and regim...
    Medical condition: Treatment of HIV-1 infection
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) IT (Prematurely Ended) DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2013-003858-25 Sponsor Protocol Number: MK-5172-052 Start Date*: 2014-03-10
    Sponsor Name:Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc.
    Full Title: A Phase II/III Randomized 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 and Chronic Kidney D...
    Medical condition: Hepatitis C
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004848 10019183 HCV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) ES (Completed) SE (Completed) EE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2006-006417-32 Sponsor Protocol Number: P04889 Start Date*: 2008-02-06
    Sponsor Name:Schering-Plough Research Institute
    Full Title: Vicriviroc in Combination Treatment with an Optimized ART Regimen in HIV-Infected Treatment-Experienced Subjects (VICTOR-E4)
    Medical condition: HIV infection (R5 tropism only) with previous therapy
    Disease: Version SOC Term Classification Code Term Level
    9.1 10200172 LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) ES (Prematurely Ended) DE (Prematurely Ended) PT (Prematurely Ended) IT (Prematurely Ended) GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-001246-33 Sponsor Protocol Number: TMC114-C208 Start Date*: 2004-11-23
    Sponsor Name:Tibotec Pharmaceuticals Limited Ireland
    Full Title: An open label trial of TMC114/RTV in HIV-1 infected subjects who were randomized in the trials TMC114-C201, TMC114-C207 or in sponsor selected Phase I trials.
    Medical condition: HIV-1 infection
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020161 HIV infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) GB (Completed) IT (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2004-005037-19 Sponsor Protocol Number: 0518-005 Start Date*: 2005-04-04
    Sponsor Name:Merck Sharp & Dohme Limited
    Full Title: Multicenter, Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Antiretroviral Activity of Raltegravir in Combination With an Optimized B...
    Medical condition: Unspecified human immunodeficiency virus [HIV] disease
    Disease: Version SOC Term Classification Code Term Level
    7.0 10020162 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Completed) ES (Completed) IT (Completed) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-005127-34 Sponsor Protocol Number: 0518-018 Start Date*: 2006-03-14
    Sponsor Name:Merck & Co. Inc.
    Full Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 in Combination With an Optimized Background Therapy (OBT), Versus Opt...
    Medical condition: Unspecified human immuno-deficiency virus [HIV] disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020160 HIV disease LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) DK (Completed) ES (Completed) PT (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-004800-20 Sponsor Protocol Number: MK-3475-937 Start Date*: 2019-08-22
    Sponsor Name:Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) versus Placebo as Adjuvant Therapy in Participants with Hepatocellular Carcinoma and Complete ...
    Medical condition: Adjuvant treatment of HCC
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073071 Hepatocellular carcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Trial now transitioned) SE (Trial now transitioned) DE (Trial now transitioned) NO (Trial now transitioned) HU (Trial now transitioned) PL (Trial now transitioned) BE (Trial now transitioned) DK (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing) GB (GB - no longer in EU/EEA) IT (Trial now transitioned) BG (Completed)
    Trial results: (No results available)
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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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