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Clinical trials for SAFETY

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   44351   clinical trials with a EudraCT protocol, of which   7378   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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    27,978 result(s) found for: SAFETY. Displaying page 1,075 of 1,399.
    EudraCT Number: 2011-003487-75 Sponsor Protocol Number: CARMEN Start Date*: 2011-10-03
    Sponsor Name:FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR
    Full Title: Phase II trial on safety and activity of intensive short-term chemoimmunotherapy in HIV-positive patients with Burkitt's lymphoma.
    Medical condition: Burkitt's lymphoma in HIV-positive patients.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006595 Burkitt's lymphoma PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-003320-51 Sponsor Protocol Number: 2013/24 Start Date*: 2015-04-29
    Sponsor Name:CENTRE ANTOINE LACASSAGNE
    Full Title: A phase 1/2 clinical trial to assess safety and efficacy of a new treatment for Hodgkin lymphoma's disease combining Adcetris¿ and Levact¿ in Old patients
    Medical condition: Hodgkin Lymphoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10020328 Hodgkin's lymphoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-000460-34 Sponsor Protocol Number: ALCAT Start Date*: 2015-11-18
    Sponsor Name:Hospital of the University of Munich
    Full Title: Effects of Acetyl-DL-Leucine on cerebellar ataxia - a multinational, multicenter, randomized, double-blind, placebo-controlled, 2-way crossover phase III trial (ALCAT)
    Medical condition: Cerebellar ataxia is a form of ataxia originating in the cerebellum and is most often caused by neurodegenerative disorders of the cerebellum, either hereditary or sporadic. The leading clinical sy...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2017-000589-31 Sponsor Protocol Number: NEMESIS Start Date*: 2018-02-02
    Sponsor Name:SOCIETà CAMPANA DI IMMUNOTERAPIA ONCOLOGICA
    Full Title: multi stage phase II trial of Nivolumab (an anti –PD-1) in patients with platinum resistant Mismatch Repair deficient germinal cells tumours
    Medical condition: patients with platinum resistant Mismatch Repair deficient germinal cells tumours
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061184 Germ cell cancer PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061184 Germ cell cancer PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-003542-17 Sponsor Protocol Number: FISM_IRON-MDS Start Date*: 2019-05-06
    Sponsor Name:FONDAZIONE ITALIANA SINDROMI MIELODISPLASTICHE ETS
    Full Title: Early and low dose Deferasirox (3.5 mg/kg FCT) to suppress NTBI and LPI as early intervention to prevent tissue iron overload in lower risk MDS
    Medical condition: Adult patients with low risk MDS
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10028532 Myelodysplasia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-002340-32 Sponsor Protocol Number: APIDULCIS Start Date*: 2019-03-19
    Sponsor Name:FONDAZIONE ARIANNA ANTICOAGULAZIONE
    Full Title: APIDULCIS: Extended anticoagulation with low-dose apixaban after a standard course anticoagulation in patients with a first venous thromboembolism who have positive d-dimer
    Medical condition: a first episode of proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10038738 - Respiratory, thoracic and mediastinal disorders 10037377 Pulmonary embolism PT
    21.1 10047065 - Vascular disorders 10051055 Deep vein thrombosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-001868-19 Sponsor Protocol Number: 2015-001 Start Date*: 2015-10-15
    Sponsor Name:University medical center of Johannes Gutenberg University Mainz
    Full Title: A randomized, double-blind, placebo-controlled, mono-center study to evaluate the effects of mepolizumab on airway physiology in patients with eosinophilic asthma: the MEMORY study
    Medical condition: severe eosinophilic asthma
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004855 10068462 Eosinophilic asthma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-003862-10 Sponsor Protocol Number: Dara-Atra Start Date*: 2016-04-01
    Sponsor Name:VU University Medical Center
    Full Title: A phase 1 and phase 2 study of daratumumab in combination with all-trans retinoic acid in relapsed/refractory multiple myeloma
    Medical condition: relapsed/refractory multiple myeloma
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004851 10028229 Multiple myelomas HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-002171-19 Sponsor Protocol Number: HEVACC Start Date*: 2021-05-12
    Sponsor Name:Medizinische Universität Innsbruck, Institut für Virologie
    Full Title: Heterologous vaccination with a Vaxzervia (ChAdOx1-S) prime and a Comirnaty (BNT162b2) boost
    Medical condition: Immunization for SARS-CoV-2
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10021433 Immunization LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005745-16 Sponsor Protocol Number: 77119 Start Date*: 2021-03-22
    Sponsor Name:Steno Diabetes Center Copenhagen
    Full Title: Pen-Administered Low-Dose Dasiglucagon for Prevention and Treatment of Hypoglycemia in People with Type 1 Diabetes: A Randomized, Open-Label, Two-Period Crossover Outpatient Study
    Medical condition: Type 1 diabetes
    Disease: Version SOC Term Classification Code Term Level
    21.1 10027433 - Metabolism and nutrition disorders 10067584 Type 1 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2018-001368-43 Sponsor Protocol Number: MVT-601-035 Start Date*: 2019-01-21
    Sponsor Name:Myovant Sciences GmbH
    Full Title: An International Phase 3 Double-Blind, Placebo-controlled, Randomized Withdrawal Study of Relugolix Co-administered with Estradiol and Norethindrone Acetate in Women with Heavy Menstrual Bleeding A...
    Medical condition: heavy menstrual bleeding associated with uterine fibroids
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004872 10027331 Menstrual flow altered LLT
    21.1 100000004864 10046783 Uterine fibroid LLT
    Population Age: Adults Gender: Female
    Trial protocol: CZ (Completed) HU (Completed) BE (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-004614-10 Sponsor Protocol Number: CA209-429 Start Date*: 2017-06-12
    Sponsor Name:University Hospital Tübingen
    Full Title: An open label phase II study to evaluate safety and efficacy of combined treatment with ipilimumab and nivolumab in patients with four and more symptomatic brain metastases of melanoma
    Medical condition: Patients with stage IV melanoma and four or more symptomatic brain metastases, who are not eligible for surgery or radiosurgery
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025655 Malignant melanoma of skin LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025671 Malignant melanoma stage IV PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006128 Brain metastases LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025650 Malignant melanoma PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027480 Metastatic malignant melanoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-001040-23 Sponsor Protocol Number: TranspoCART19 Start Date*: 2023-03-15
    Sponsor Name:Instituto de Investigación Biomédica de Salamanca (IBSAL) - IECSCYL
    Full Title: Phase I/IIa multicentre phase I/IIa study of infusion of autologous peripheral blood T lymphocytes expanded and genetically modified using Sleeping Beauty family transposons to express a chimeric a...
    Medical condition: Relapsed or refractory B-cell lymphoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10003900 B-cell lymphomas NEC HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-003923-17 Sponsor Protocol Number: SH600008 Start Date*: 2023-01-26
    Sponsor Name:Sanofi Pasteur
    Full Title: Safety and Immunogenicity Study of Full Schedule (3-Dose of Shan6™) or Shan6™-Shan5®-Shan6™ Versus the Licensed Vaccine Shan5® With bOPV (bivalent oral polio vaccine) and IPV (inactivated poliomyel...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10069577 Pertussis immunisation PT
    21.1 10042613 - Surgical and medical procedures 10054129 Diphtheria immunisation PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-003288-31 Sponsor Protocol Number: TUD-CELIM2-050 Start Date*: 2012-06-04
    Sponsor Name:Technical University Dresden
    Full Title: Open, randomized, multicenter phase II trial with cetuximab /5-FU/FA/irinotecan or cetuximab/5-FU/FA /irinotecan/oxaliplatin in ras wild type patients or with irinotecan/oxaliplatin/5-FU/FA with or...
    Medical condition: The aim of this study is to investigate the following schedules for efficacy with regard to response rate in neoadjuvant treatment of patients with non-resectable liver metastases: - Cetuximab/FOL...
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052362 Metastatic colorectal cancer LLT
    19.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10027457 Metastases to liver PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-002285-23 Sponsor Protocol Number: POETIG Start Date*: 2017-01-18
    Sponsor Name:Universitaetsklinikum Essen
    Full Title: Phase 2 trial of ponatinib in patients with metastatic and/or unresectable gastrointestinal stromal tumor (GIST) following failure or intolerance of prior therapy with imatinib (POETIG trial – POna...
    Medical condition: gastrointestinal stromal tumor (GIST)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10051066 Gastrointestinal stromal tumour PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-010319-34 Sponsor Protocol Number: OSI-906-202 Start Date*: 2009-09-24
    Sponsor Name:Astellas Pharma Global Development, Inc.
    Full Title: A Phase 1/2 Study Evaluating Intermittent and Continuous OSI 906 and Weekly Paclitaxel in Patients with Recurrent Epithelial Ovarian Cancer (and Other Solid Tumors)
    Medical condition: Recurrent Epithelial Ovarian Cancer and Other Solid Tumors
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10049280 Solid tumour LLT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066697 Ovarian cancer recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) PL (Completed) CZ (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2022-002188-31 Sponsor Protocol Number: HLX14-002-PMOP301 Start Date*: 2022-11-25
    Sponsor Name:Shanghai Henlius Biotech, Inc.
    Full Title: A Randomized, Double-Blind, International Multicenter, Parallel-Controlled Phase III Clinical Study to Evaluate Recombinant Anti-RANKL Human Monoclonal Antibody Injection (HLX14) Versus Denosumab I...
    Medical condition: Osteoporosis at High Risk of Fracture
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10031282 Osteoporosis PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: HU (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-000734-21 Sponsor Protocol Number: 2014RC07 Start Date*: 2016-09-07
    Sponsor Name:University of Dundee & NHS Tayside
    Full Title: Investigating the mechanism of inhaled corticosteroids associated pneumonia by longitudinal characterisation of the airway microbiome in patients with severe COPD
    Medical condition: Chronic Obstructive Pulmonary Diseae
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10009033 Chronic obstructive pulmonary disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-004005-81 Sponsor Protocol Number: GC1801 Start Date*: 2021-01-25
    Sponsor Name:Instituto Grifols, S.A.
    Full Title: A prospective, multicenter, open-label, single-arm study to evaluate the efficacy and safety of human plasma-derived fibrinogen concentrate (FIB Grifols) in subjects with congenital afibrinogenaemi...
    Medical condition: Congenital Afibrinogenaemia and Severe Hypofibrinogenemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10052651 Afibrinogenaemia LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Prematurely Ended)
    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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