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Clinical trials for Clinical Trials Directive

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   44341   clinical trials with a EudraCT protocol, of which   7370   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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    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
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    31 result(s) found for: Clinical Trials Directive. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2014-002248-42 Sponsor Protocol Number: JMC-2014-6TG/6MP Start Date*: 2014-10-22
    Sponsor Name:Bonkolab, Rigshospitalet
    Full Title: The TEAM Study (Thiopurine EnhAnced Maintenance therapy) A Phase 1-2 Study of 6-Thioguanine in Combination with Methotrexate and 6-Mercaptopurine During Maintenance Therapy of Childhood, Adolesce...
    Medical condition: Acute Lymphoblastic Leukemia Lymphoblastic Non-Hodgkin’s Lymphoma
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DK (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2010-023003-96 Sponsor Protocol Number: BAY86-4875/91741 Start Date*: 2012-04-25
    Sponsor Name:Bayer HealthCare AG
    Full Title: Open-label, multicenter, pharmacokinetic, and safety study in children (term newborn infants to 23 months of age) undergoing a contrast-enhanced MRI with an intravenous injection of 0.1 mmol/kg BW ...
    Medical condition: Pediatric subjects aged <2 years (term newborn infants to toddlers 23 months of age inclusive) scheduled to undergo routine gadolinium-enhanced MRI of any body region
    Disease:
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2020-001467-82 Sponsor Protocol Number: P020.051 Start Date*: 2020-10-23
    Sponsor Name:Leiden University Medical Center
    Full Title: An Open-Label Study Evaluating Anti-Viral Effects of Voclosporin in SARS-CoV-2 Positive Kidney Transplant Recipients – the VOCOVID Study (COVID-19)
    Medical condition: SARS-CoV-2 infection in Kidney Transplant Recipients
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    21.1 100000004865 10052212 Organ transplant NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-005836-25 Sponsor Protocol Number: BAY73-4506/15967 Start Date*: 2012-06-12
    Sponsor Name:Bayer HealthCare AG
    Full Title: An open-label phase IIIb study of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy
    Medical condition: Colorectal neoplasms
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) CZ (Completed) ES (Completed) GB (Completed) IT (Completed) AT (Completed) NL (Completed) IE (Completed) FR (Completed) PT (Completed) FI (Completed) SE (Completed) GR (Completed) HU (Completed) PL (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2011-001953-10 Sponsor Protocol Number: ALD-102 Start Date*: 2013-12-13
    Sponsor Name:bluebird bio, Inc.
    Full Title: A phase 2/3 study of the efficacy and safety of hematopoietic stem cells transduced with Lenti D lentiviral vector for the treatment of cerebral adrenoleukodystrophy (CALD)
    Medical condition: Cerebral Adrenoleukodystrophy (CALD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10051260 Adrenoleukodystrophy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed) DE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-002563-10 Sponsor Protocol Number: BAY86-4875/15961 Start Date*: 2013-06-06
    Sponsor Name:Bayer HealthCare AG
    Full Title: Multicenter open-label study to evaluate efficacy of gadobutrol-enhanced cardiac magnetic resonance imaging (CMRI) for detection of significant coronary artery disease (CAD) in subjects with known ...
    Medical condition: Subjects with known or suspected Coronary Artery Disease (CAD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-002065-37 Sponsor Protocol Number: BAY86-5028 / 14371 Start Date*: 2011-09-12
    Sponsor Name:Bayer HealthCare AG
    Full Title: Multi-center, single-arm study to assess the safety, efficacy, discontinuation rate and pharmacokinetics of the low-dose levonorgestrel intrauterine contraceptive system (LCS12) in post-menarcheal ...
    Medical condition: Contraception
    Disease: Version SOC Term Classification Code Term Level
    14.0 10042613 - Surgical and medical procedures 10010808 Contraception PT
    Population Age: Adolescents, Under 18 Gender: Female
    Trial protocol: SE (Completed) FI (Completed) NL (Completed) AT (Completed) BE (Completed) DE (Completed) DK (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2012-004180-43 Sponsor Protocol Number: BAY59-7939/15786 Start Date*: 2013-03-13
    Sponsor Name:Bayer HealthCare AG
    Full Title: A randomized controlled trial of rivaroxaban for the prevention of major cardiovascular events in patients with coronary or peripheral artery disease (COMPASS - Cardiovascular OutcoMes for People u...
    Medical condition: Prevention of major cardiovascular events in patients with coronary or peripheral artery disease
    Disease: Version SOC Term Classification Code Term Level
    18.0 10042613 - Surgical and medical procedures 10064939 Cardiovascular event prophylaxis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) SE (Completed) CZ (Completed) FI (Completed) IT (Completed) HU (Completed) NL (Completed) GB (Completed) SK (Completed) DK (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2013-003118-42 Sponsor Protocol Number: BAY88-8223/16507 Start Date*: 2014-08-08
    Sponsor Name:Bayer AG
    Full Title: A three arm randomized, open-label Phase II study of radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) versus 80 kBq/kg (88 kBq/kg after implementation of NIST update)...
    Medical condition: Castration resistant prostate cancer with bone metastasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: DE (Completed) IT (Completed) CZ (Completed) SE (Completed) FI (Completed) ES (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-003718-18 Sponsor Protocol Number: CCR3689 Start Date*: 2012-02-09
    Sponsor Name:Royal Marsden Hospital NHS Foundation Trust
    Full Title: Proof-of-concept study of AZD 4547 in patients with FGFR1 or FGFR2 amplified tumours
    Medical condition: Advanced Breast Cancer Advanced Lung Cancer Advanced Upper gastrointestinal cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-005525-39 Sponsor Protocol Number: CCR4449 Start Date*: 2016-05-19
    Sponsor Name:The Royal Marsden NHS Foundation Trust
    Full Title: Proof-of-concept study of ibrutinib in c-MYC and HER2 amplified gastrooesophageal carcinoma
    Medical condition: Her2 or cMYC positive advanced oesophagogastric carcinomas
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2007-005976-15 Sponsor Protocol Number: CCR3024 Start Date*: 2008-03-27
    Sponsor Name:Royal Marsden Hospital NHS Trust
    Full Title: A randomised open-labelled multicentre trial of the efficacy of epirubicin, oxaliplatin and capecitabine (EOX) with or without panitumumab in previously untreated advanced oesophago-gastric cancer ...
    Medical condition: Advanced (Inoperable locally advanced, metastatic or recurrent) , histologically verified adenocarcinoma or undifferentiated carcinoma of the oesophagus, oesophagogastric junction or stomach.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10017770 Gastric carcinoma LLT
    9.1 10030155 Oesophageal carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-005176-17 Sponsor Protocol Number: BP-I-008 Start Date*: 2016-10-20
    Sponsor Name:Bellicum Pharmaceuticals, Inc.
    Full Title: A Phase I Study of Safety, Pharmacokinetics and Efficacy of Donor BPX-501 Cells and AP1903 Infusion for Children with Recurrent or Minimal Residual Disease Hematologic Malignancies After Allogeneic...
    Medical condition: recurrent or minimal residual disease (MRD) hematologic malignancies post-allogeneic transplant
    Disease: Version SOC Term Classification Code Term Level
    20.0 10005329 - Blood and lymphatic system disorders 10018849 Haematological disorders NEC HLGT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-001949-13 Sponsor Protocol Number: InterAACTCCR3847 Start Date*: 2013-10-31
    Sponsor Name:Royal Marsden NHS Foundation Trust
    Full Title: An International Multicentre Open Label Randomised Phase II Advanced Anal Cancer Trial Comparing Cisplatin plus 5-fluorouracil versus Carboplatin plus Weekly Paclitaxel in Patients with Inoperable ...
    Medical condition: Inoperable, locally recurrent or metastatic squamous cell carcinoma of the anus
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004864 10041815 Sq cell Ca anus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-002167-33 Sponsor Protocol Number: 16673 Start Date*: 2016-11-23
    Sponsor Name:Bayer AG
    Full Title: A randomized, double-blind multicenter study to assess the safety and efficacy of a six month oral treatment with the chymase inhibitor BAY 1142524 at a dose of 25 mg BID in comparison to placebo o...
    Medical condition: Left-ventricular dysfunction after acute myocardial infarction
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2009-017313-30 Sponsor Protocol Number: BAY59-7939/12892 Start Date*: 2010-06-04
    Sponsor Name:Bayer HealthCare AG
    Full Title: Single-dose pilot study of oral rivaroxaban in pediatric subjects with venous thromboembolism
    Medical condition: Venous thromboembolism.
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) IT (Completed) IE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2018-001145-14 Sponsor Protocol Number: ALD-104 Start Date*: 2019-04-17
    Sponsor Name:bluebird bio, Inc.
    Full Title: A Phase 3 Study of Lenti-D Drug Product After Myeloablative Conditioning Using Busulfan and Fludarabine in Subjects ≤17 Years of Age With Cerebral Adrenoleukodystrophy (CALD)
    Medical condition: Cerebral Adrenoleukodystrophy (CALD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10051260 Adrenoleukodystrophy PT
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed) DE (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-005088-82 Sponsor Protocol Number: CAFQ056A2204 Start Date*: 2008-05-15
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A multi-centre, randomized, double-blind, placebo-controlled, two-period, crossover proof-of-concept study in patients with Fragile X Syndrome to assess the efficacy, safety and tolerability of mul...
    Medical condition: Fragile X Syndrome
    Disease: Version SOC Term Classification Code Term Level
    9.1 10017324 Fragile X syndrome PT
    Population Age: Adults Gender: Male
    Trial protocol: FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-003650-88 Sponsor Protocol Number: BAY94-9343/15743 Start Date*: 2015-11-25
    Sponsor Name:Bayer AG
    Full Title: A randomized, open-label, active-controlled, Phase II study of intravenous anetumab ravtansine (BAY 94-9343) or vinorelbine in patients with advanced or metastatic malignant pleural mesothelioma ov...
    Medical condition: Patients with advanced or metastatic malignant pleural mesothelioma overexpressing mesothelin
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10035605 Pleural mesothelioma malignant advanced LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) DE (Completed) BE (Completed) GB (Completed) ES (Completed) NL (Completed) PL (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-000925-19 Sponsor Protocol Number: BAY80-6946/17322 Start Date*: 2015-03-23
    Sponsor Name:Bayer Healthcare AG
    Full Title: A randomized, double-blind Phase III study of copanlisib versus placebo in patients with rituximab-refractory indolent non-Hodgkin’s lymphoma (iNHL) - CHRONOS-2
    Medical condition: Patients with rituximab-refractory indolent non-Hodgkin's lymphoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) IE (Completed) GR (Completed) PL (Completed) IT (Prematurely Ended)
    Trial results: View results
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    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
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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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