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Clinical trials for Never Events

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   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    140 result(s) found for: Never Events. Displaying page 1 of 7.
    1  2  3  4  5  6  7  Next»
    EudraCT Number: 2005-004517-14 Sponsor Protocol Number: 106252 Start Date*: 2005-11-14
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Open study to determine the immunogenicity and reactogenicity of Influsplit SSW 2005/2006 in children from 6 years until 13 years of age
    Medical condition: Immunization against Influenza in healthy children and children with underlying diseases aged between 6 and 13 years
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-002025-11 Sponsor Protocol Number: ALXN1210-PNH-301 Start Date*: 2016-12-02
    Sponsor Name:Alexion Pharmaceuticals Incorporated
    Full Title: A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Medical condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004857 10055629 Paroxysmal nocturnal hemoglobinuria LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) SE (Completed) BE (Completed) CZ (Completed) DK (Prematurely Ended) PT (Prematurely Ended) FI (Prematurely Ended) ES (Ongoing) NL (Completed) AT (Completed) EE (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-006161-11 Sponsor Protocol Number: RC31/20/0421 Start Date*: 2021-06-23
    Sponsor Name: Toulouse University Hospital
    Full Title: LONG -TERM INTERVENTIONAL FOLLOW-UP STUDY UP TO 4 YEARS OF AGE OF CHILDREN WITH PRADER-WILLI SYNDROME INCLUDED IN THE OTBB3 CLINICAL TRIAL AND COMPARISON WITH AN UNTREATED COHORT OF CHILDREN WITH P...
    Medical condition: Prader-willi syndrome
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-017661-34 Sponsor Protocol Number: 1200.55 Start Date*: 2013-06-25
    Sponsor Name:Boehringer Ingelheim RCV GmbH & Co KG
    Full Title: An open label trial of afatinib (Giotrif) in treatment-naive (1st line) or chemotherapy pre-treated patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mu...
    Medical condition: Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have never been treated with an EGFR-TKI
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) IT (Completed) ES (Completed) AT (Completed) GR (Completed) PT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-001162-10 Sponsor Protocol Number: EUOG2014-002 Start Date*: 2015-05-06
    Sponsor Name:European Uro- Oncology Group (EUOG)
    Full Title: An Exploratory Phase 2, open-label, single-arm, efficacy and imaging Study of Oral Enzalutamide (MDV3100) Androgen Receptor (AR)-Directed Therapy in Hormono-Naïve patients with Metastatic Prostate ...
    Medical condition: Patients with Metastatic Prostate Cancer who have never been treated with Androgen Deprivation Therapy
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-003438-33 Sponsor Protocol Number: BAY88-8223/15396 Start Date*: 2014-04-23
    Sponsor Name:Bayer HealthCare AG
    Full Title: A phase III randomized, double-blind, placebo-controlled trial of radium-223 dichloride in combination with abiraterone acetate and prednisone/prednisolone in the treatment of asymptomatic or mildl...
    Medical condition: Asymptomatic or mildly symptomatic chemotherapy-naïve bone predominant metastatic castration-resistant prostate cancer
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IT (Completed) ES (Completed) FI (Completed) SE (Completed) DE (Completed) BE (Completed) GB (Completed) NL (Completed) NO (Completed) PL (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2015-004717-25 Sponsor Protocol Number: Low-PV Start Date*: 2016-07-08
    Sponsor Name:FONDAZIONE PER LA RICERCA OSPEDALE MAGGIORE DI BERGAMO - FROM
    Full Title: The benefit/risk profile of pegylated proline-Interferon alpha-2b (AOP2014) added to the best available strategy based on phlebotomies in low-risk patients with Polycythemia Vera (PV). The Low-PV r...
    Medical condition: Polycythemia Vera
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10036061 Polycythemia vera LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-003069-33 Sponsor Protocol Number: DS8201-A-U303 Start Date*: 2019-07-03
    Sponsor Name:Daiichi Sankyo Inc.
    Full Title: A phase 3, multicenter, randomized, open-label, active-controlled trial of trastuzumab deruxtecan (T-DXd), an anti-HER2-antibody drug conjugate (ADC), versus treatment of physician's choice for HER...
    Medical condition: Unresectable and/or metastatic breast cancer that is human epidermal growth factor receptor 2 (HER2)-low
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) SE (Completed) IT (Completed) GR (Completed) PT (Completed) DE (Prematurely Ended) ES (Ongoing) GB (GB - no longer in EU/EEA) HU (Completed)
    Trial results: View results
    EudraCT Number: 2009-015713-51 Sponsor Protocol Number: 205.452 Start Date*: 2010-06-09
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG, Medical Affairs Germany
    Full Title: A randomized, active-controlled, double-blind, double-dummy, parallel group design, multi-center trial to compare the efficacy and safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution delivered...
    Medical condition: Chronic obstructive pulmonary disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) FI (Completed) LV (Completed) HU (Completed) NO (Completed) LT (Completed) SK (Completed) SE (Completed) ES (Completed) NL (Completed) DK (Completed) PT (Completed) GR (Completed) AT (Completed) IT (Completed) IE (Completed) BG (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-001840-33 Sponsor Protocol Number: 205.389 Start Date*: 2007-11-13
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: Effect of inhalation of tiotropium once daily 18 mcg versus salmeterol twice daily 50 mcg on time to first exacerbation in COPD patients (a randomised, double-blind, double-dummy, parallel group, o...
    Medical condition: chronic obstructive pulmonary disease (COPD)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) HU (Completed) FI (Completed) GB (Completed) AT (Completed) CZ (Completed) DK (Completed) PT (Completed) LV (Completed) ES (Completed) NL (Completed) SI (Completed) FR (Completed) BE (Completed) DE (Completed) IT (Completed) SK (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2020-003265-19 Sponsor Protocol Number: PD0053 Start Date*: 2021-06-07
    Sponsor Name:UCB Biopharma SRL
    Full Title: A Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkins...
    Medical condition: Early-stage Parkinson's disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10061536 Parkinson's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) PL (Completed) ES (Completed) NL (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002637-11 Sponsor Protocol Number: CBYL719H12301 Start Date*: 2020-03-18
    Sponsor Name:Novartis Pharma AG
    Full Title: EPIK-B3: A Phase III, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with nab-paclitaxel in patients with adv...
    Medical condition: Advanced triple negative breast cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) FR (Completed) SK (Completed) DE (Completed) GB (GB - no longer in EU/EEA) IT (Completed) NO (Completed) AT (Completed) BG (Completed) SI (Completed) PL (Completed) HR (Completed) GR (Completed) RO (Completed) PT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-002257-30 Sponsor Protocol Number: AT2220-017 Start Date*: Information not available in EudraCT
    Sponsor Name:Amicus Therapeutics, Inc.
    Full Title: AN OPEN-LABEL SAFETY AND DOSE-FINDING STUDY OF INTRAVENOUS DUVOGLUSTAT CO-ADMINISTERED WITH RECOMBINANT HUMAN ACID α-GLUCOSIDASE IN SUBJECTS WITH POMPE DISEASE
    Medical condition: Pompe disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10036143 Pompe's disease LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-004484-31 Sponsor Protocol Number: NN9931-4492 Start Date*: 2019-05-13
    Sponsor Name:Novo Nordisk A/S
    Full Title: Investigation of efficacy and safety of semaglutide s.c. once-weekly versus placebo in subjects with non-alcoholic steatohepatitis and compensated liver cirrhosis
    Medical condition: Non-alcoholic steatohepatitis Compensated liver cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10019805 - Hepatobiliary disorders 10053219 Non-alcoholic steatohepatitis PT
    20.0 10019805 - Hepatobiliary disorders 10024667 Liver cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) FR (Completed) ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2020-005032-30 Sponsor Protocol Number: FLT201-01 Start Date*: 2023-03-13
    Sponsor Name:Freeline Therapeutics Limited
    Full Title: A Phase 1/2, open-label, safety, tolerability and efficacy study of FLT201 in adult patients with Gaucher disease Type 1 (Galileo-1)
    Medical condition: Type 1 Gaucher Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    20.0 10010331 - Congenital, familial and genetic disorders 10075697 Gaucher's disease type I PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-003474-31 Sponsor Protocol Number: COAV101B12301 Start Date*: 2023-06-01
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, sham-controlled, double-blind study to evaluate the efficacy and safety of intrathecal (IT) OAV101 in patients with later onset Type 2 spinal muscular atrophy (SMA) who are ≥ 2 to < 1...
    Medical condition: Spinal Muscular Atrophy
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10041582 Spinal muscular atrophy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed) GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-021785-30 Sponsor Protocol Number: A4001095 Start Date*: 2011-12-07
    Sponsor Name:ViiV Healthcare UK Limited
    Full Title: A MULTICENTER, RANDOMIZED, DOUBLE BLIND, COMPARATIVE TRIAL OF MARAVIROC + DARUNAVIR/RITONAVIR VERSUS EMTRICITABINE/TENOFOVIR + DARUNAVIR/RITONAVIR FOR THE TREATMENT OF ANTIRETROVIRAL NAÏVE HIV INFE...
    Medical condition: HIV infection
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10068341 HIV-1 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) SE (Prematurely Ended) FI (Prematurely Ended) BE (Prematurely Ended) ES (Prematurely Ended) GB (Prematurely Ended) AT (Completed) DK (Prematurely Ended) NL (Completed) PT (Prematurely Ended) PL (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-003038-26 Sponsor Protocol Number: ARGX-113-1603 Start Date*: 2017-02-08
    Sponsor Name:Argenx BVBA
    Full Title: A Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia, followed by an Op...
    Medical condition: Primary Immune Thrombocytopenia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004851 10074678 Primary immune thrombocytopenic purpura LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) CZ (Completed) BE (Completed) DE (Completed) AT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2019-002663-10 Sponsor Protocol Number: 232SM203 Start Date*: 2020-03-27
    Sponsor Name:Biogen Idec Research Limited
    Full Title: Escalating Dose and Randomized, Controlled Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy
    Medical condition: Muscular Atrophy, Spinal
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10041582 Spinal muscular atrophy PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: LV (Completed) IE (Completed) HU (Completed) PL (Completed) ES (Ongoing) GB (GB - no longer in EU/EEA) DE (Completed) FR (Completed) GR (Completed) IT (Completed) NL (Ongoing)
    Trial results: View results
    EudraCT Number: 2017-001499-43 Sponsor Protocol Number: TACSI-01 Start Date*: 2017-11-23
    Sponsor Name:Sahlgrenska University Hospital
    Full Title: Dual antiplatelet therapy with ticagrelor and acetylsalicylic acid (ASA) vs. ASA only after isolated coronary artery bypass grafting in patients with acute coronary syndrome (TACSI trial)
    Medical condition: Coronary artery multi-vessel disease and left main stenosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10011098 Coronary bypass LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Trial now transitioned) NO (Trial now transitioned) FI (Trial now transitioned) DK (Trial now transitioned) IS (Trial now transitioned)
    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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