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Clinical trials for Emergency Use Authorization

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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    21 result(s) found for: Emergency Use Authorization. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2010-024249-59 Sponsor Protocol Number: ULA01 Start Date*: 2012-10-18
    Sponsor Name:Cardiorentis Ltd.
    Full Title: Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ularitide (Urodilatin) Intravenous Infusion in Patients Suffering from Acute Decomp...
    Medical condition: Acute Decompensated Heart Failure
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Prematurely Ended) HU (Prematurely Ended) NL (Prematurely Ended) FI (Prematurely Ended) IT (Completed) LT (Prematurely Ended) EE (Prematurely Ended) LV (Prematurely Ended) ES (Prematurely Ended) PL (Prematurely Ended) SE (Ongoing) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-000954-67 Sponsor Protocol Number: ATB200-07 Start Date*: 2020-04-08
    Sponsor Name:Amicus Therapeutics, Inc.
    Full Title: A Phase 3 Open-label Extension Study to Assess the Long-term Safety and Efficacy of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late-onset Pompe Disease
    Medical condition: Adult Subjects With Late Onset Pompe Disease (LOPD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10075702 Pompe's disease late onset LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Ongoing) DE (Completed) DK (Trial now transitioned) FR (Trial now transitioned) BE (Trial now transitioned) GR (Trial now transitioned) SI (Trial now transitioned) AT (Completed) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-002403-13 Sponsor Protocol Number: Ularitide-1502 Start Date*: 2006-11-20
    Sponsor Name:PDL BioPharma Inc
    Full Title: A Phase 3, Randomized, Double-blinded, Placebo-controlled Study of Ularitide in the Treatment of Subjects with Acute Decompensated Heart Failure
    Medical condition: Acute decompensated heart failure
    Disease: Version SOC Term Classification Code Term Level
    8.1 10000803 Acute heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Prematurely Ended) LT (Prematurely Ended) AT (Temporarily Halted)
    Trial results: (No results available)
    EudraCT Number: 2021-001393-31 Sponsor Protocol Number: ABNCoV2-01 Start Date*: 2021-08-12
    Sponsor Name:Bavarian Nordic A/S
    Full Title: An Open Label Phase 2 Trial to Evaluate the Safety, Tolerability and Immunogenicity of the ABNCoV2 Vaccine in SARS-CoV-2 Seronegative and Seropositive Adult Subjects.
    Medical condition: COVID-19 disease
    Disease: Version SOC Term Classification Code Term Level
    23.1 10042613 - Surgical and medical procedures 10084457 COVID-19 immunisation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-004376-11 Sponsor Protocol Number: AZM-MD-302 Start Date*: 2012-05-15
    Sponsor Name:Forest Research Institute, Inc.
    Full Title: A Phase 3 Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Effects of Once-Daily Oral Doses of 75 mg Azimilide Dihydrochloride on the Incidence of Cardiovascular Hospitalizat...
    Medical condition: Ventricular arrhythmia in patients with implantable cardioverter-defibrillator (ICD)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10007541 - Cardiac disorders 10047281 Ventricular arrhythmia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) NL (Prematurely Ended) ES (Prematurely Ended) DE (Prematurely Ended) SE (Prematurely Ended) CZ (Prematurely Ended) DK (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-000381-29 Sponsor Protocol Number: SCY-078-301 Start Date*: 2017-07-17
    Sponsor Name:SCYNEXIS, Inc.
    Full Title: Open-Label Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients with Fungal Diseases that are Refractory to, Resistant to or Intolerant of Standard Antifungal Treatment (FURI)
    Medical condition: Patients > 18 years of age with a documented invasive and/or severe fungal disease that has been intolerant, resistant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) ES (Ongoing) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2012-003176-39 Sponsor Protocol Number: 205MS303 Start Date*: 2013-05-31
    Sponsor Name:Biogen Idec Research Limited
    Full Title: A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Hav...
    Medical condition: Relapsing-remitting Multiple Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) IT (Prematurely Ended) CZ (Completed) HU (Completed) PL (Completed) SE (Completed) ES (Completed) IE (Prematurely Ended) GB (Completed) FI (Prematurely Ended) GR (Completed) FR (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2021-005504-36 Sponsor Protocol Number: ABNCoV2-03 Start Date*: 2022-09-19
    Sponsor Name:Bavarian Nordic A/S
    Full Title: Evaluation of the Immunogenicity, Safety, and Tolerability of a Single Dose of ABNCoV2 Vaccine in Adult Subjects Previously Vaccinated for SARS-CoV-2: a Phase 3 Trial in Two Parts—Randomized, Doubl...
    Medical condition: COVID-19 disease
    Disease: Version SOC Term Classification Code Term Level
    23.1 10042613 - Surgical and medical procedures 10084457 COVID-19 immunisation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2011-003075-11 Sponsor Protocol Number: 9HB01EXT Start Date*: 2011-12-05
    Sponsor Name:Biogen Idec Research Ltd
    Full Title: An Open-Label, Multicenter Evaluation of the Long-Term Safety and Efficacy of Recombinant, Human Coagulation Factor IX Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding Episodes i...
    Medical condition: The medical condition to be investigated is Hemophilia B, or Christmas disease. Hemophilia B is a deficiency in the clotting FIX and is a recessively inherited coagulation disorder due to an X-chro...
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004850 10053754 Hemophilia B without inhibitors LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male
    Trial protocol: GB (Completed) DE (Completed) BE (Completed) SE (Completed) PL (Completed) IT (Completed) IE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2022-000662-18 Sponsor Protocol Number: CORT125134-556 Start Date*: 2023-02-27
    Sponsor Name:CORCEPT THERAPEUTICS
    Full Title: A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian...
    Medical condition: Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10033128 Ovarian cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10016180 Fallopian tube cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061344 Peritoneal neoplasm PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Trial now transitioned) HU (Trial now transitioned) BE (Trial now transitioned) FR (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-004854-41 Sponsor Protocol Number: 252LH301 Start Date*: 2018-11-09
    Sponsor Name:Biogen Idec Research Limited
    Full Title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous BIIB093 (Glibenclamide) for Severe Cerebral Edema followi...
    Medical condition: Cerebral edema following Large Hemispheric Infarction
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10008107 Cerebral edema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) CZ (Completed) DK (Prematurely Ended) BE (Completed) PT (Prematurely Ended) ES (Prematurely Ended) HU (Completed) FI (Completed) LT (Completed) IT (Prematurely Ended) HR (Completed)
    Trial results: View results
    EudraCT Number: 2015-005220-26 Sponsor Protocol Number: ACE-LY-308 Start Date*: 2017-05-16
    Sponsor Name:Acerta Pharma BV
    Full Title: A Phase 3, Randomized, Double blind, Placebo controlled, Multicenter Study of Bendamustine and Rituximab (BR) alone Versus in Combination with Acalabrutinib (ACP 196) in Subjects with Previously Un...
    Medical condition: Mantle Cell Lymphoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10026798 Mantle cell lymphomas HLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) DE (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing) CZ (Trial now transitioned) GR (Trial now transitioned) PL (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned) RO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-005429-10 Sponsor Protocol Number: EORTC-1926-BTG Start Date*: 2022-03-28
    Sponsor Name:European Organisation for Research and Treatment of Cancer EORTC
    Full Title: Romiplostim for thrombocytopenia induced by lomustine at first progression of MGMT promoter-methylated glioblastoma: a randomized phase II open label multicenter study
    Medical condition: thrombocytopenia caused by chemotherapy drug lomustine
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10043554 Thrombocytopenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-000921-29 Sponsor Protocol Number: ALLN-177-302 Start Date*: 2019-11-12
    Sponsor Name:Allena Pharmaceuticals, Inc.
    Full Title: Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients with Enteric Hyperoxaluria: A Phase III Randomized, Double-Blind, Placebo-Controlled Study (URIROX-2)
    Medical condition: Enteric Hyperoxaluria
    Disease: Version SOC Term Classification Code Term Level
    20.1 10038359 - Renal and urinary disorders 10020703 Hyperoxaluria PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) AT (Completed) DE (Prematurely Ended) GB (GB - no longer in EU/EEA) PT (Completed) ES (Prematurely Ended) IT (Prematurely Ended) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2021-002479-20 Sponsor Protocol Number: 80202135MYG2001 Start Date*: 2022-09-29
    Sponsor Name:Janssen-Cilag Invernational N.V.
    Full Title: An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to less than 18 years with Generalized Myasthe...
    Medical condition: Myasthenia gravis (MG)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10028417 Myasthenia gravis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) Outside EU/EEA PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-002584-63 Sponsor Protocol Number: VAC31518COV2001 Start Date*: 2020-09-02
    Sponsor Name:Janssen Vaccines & Prevention B.V.
    Full Title: A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55 Years Inclusive and Adults ...
    Medical condition: Healthy Volunteers (Prevention of COVID-19)
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004865 10084465 COVID-19 vaccination LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) ES (Restarted) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-003073-28 Sponsor Protocol Number: 8HA02PED Start Date*: 2012-05-31
    Sponsor Name:Biogen Idec Research Ltd
    Full Title: An Open-Label, Multicenter Evaluation of Safety, Pharmacokinetics, and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein, BIIB031, in the Prevention and Treatment of Bleeding Episod...
    Medical condition: Severe Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004850 10053753 Hemophilia A without inhibitors LLT
    14.1 100000004850 10060612 Hemophilia A LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: GB (Completed) IE (Completed) NL (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2020-003643-29 Sponsor Protocol Number: VAC31518COV3009 Start Date*: 2020-11-10
    Sponsor Name:Janssen Vaccines & Prevention B.V.
    Full Title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older E...
    Medical condition: Healthy Volunteers, with or without comorbidities (Prevention of SARS-CoV-2-mediated COVID-19)
    Disease: Version SOC Term Classification Code Term Level
    23.1 100000004865 10084465 COVID-19 vaccination LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed) DE (Completed) ES (Temporarily Halted) BE (Completed)
    Trial results: View results
    EudraCT Number: 2015-000717-40 Sponsor Protocol Number: CCD-05993AB2-02 Start Date*: 2015-12-04
    Sponsor Name:Chiesi Farmaceutici S.p.A.
    Full Title: A 52 week, randomized, double blind, multinational, multicentre, active controlled, 3-arm parallel group trial comparing CHF 5993 200/6/12.5 µg pMDI (fixed combination of extrafine beclometasone di...
    Medical condition: Uncontrolled asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) SK (Completed) DE (Completed) PT (Completed) HU (Completed) LT (Completed) ES (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-003772-37 Sponsor Protocol Number: CTBM100C2302 Start Date*: 2006-01-06
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects
    Medical condition: Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    10011762
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) ES (Completed) IT (Completed) HU (Completed) GR (Completed) IE (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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