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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   44353   clinical trials with a EudraCT protocol, of which   7380   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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    27,980 result(s) found for: SAFETY. Displaying page 596 of 1,399.
    EudraCT Number: 2015-005416-15 Sponsor Protocol Number: SIPA-SOS Start Date*: 2016-10-20
    Sponsor Name:Medical Center - University of Freiburg [...]
    1. Medical Center - University of Freiburg
    2. Medical Center - University of Freiburg
    Full Title: An open label phase II study of Sirolimus in patients with segmental overgrowth syndrome
    Medical condition: Segmental overgrowth syndrome
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2022-002500-21 Sponsor Protocol Number: Apollo01 Start Date*: 2023-04-11
    Sponsor Name:LUMC
    Full Title: Neo-adjuvant Pembrolizumab in vulvar squamous cell carcinoma: a clinical proof-of-concept study.
    Medical condition: Vulvar squamous cell carcinoma (VSCC) Clinically diagnosed FIGO I-III primary VSCC patients to be treated with surgery with curative intent
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-003855-47 Sponsor Protocol Number: AP301-II-002 Start Date*: 2018-02-27
    Sponsor Name:Apeptico Forschung und Entwicklung GmbH
    Full Title: Safety and preliminary efficacy of sequential multiple ascending doses of solnatide to treat pulmonary permeability oedema in patients with moderate-to-severe ARDS - a randomised, placebo-controlle...
    Medical condition: pulmonary permeability oedema in patients with moderate-to-severe ARDS
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003083 ARDS LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10037423 Pulmonary oedema PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-004108-16 Sponsor Protocol Number: HOFATA_v3.0 Start Date*: 2022-04-21
    Sponsor Name:Medical University Vienna
    Full Title: Host factors predicting target site concentration of antibiotics in critically ill patients: An explorative pharmacokinetic biomarker study
    Medical condition: All patients given standard of care intravenous therapy of the studied antibiotics will be screened against the inclusion criteria. Two groups are included: Group A (septic patients with organ dysf...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-003579-36 Sponsor Protocol Number: BAY73-4506/15906 Start Date*: 2018-01-15
    Sponsor Name:Bayer HealthCare AG
    Full Title: A multi-center, open-label, non-randomized, phase I dose escalation study of regorafenib (BAY 73-4506) in pediatric subjects with solid malignant tumors that are recurrent or refractory to standard...
    Medical condition: Pediatric patients with solid malignant tumors that are recurrent or refractory to standard therapy.
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) GB (Completed) FR (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2014-002048-42 Sponsor Protocol Number: MO29406 Start Date*: 2015-01-29
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: An single arm open-label multi-centre extension study of pertuzumab administered as a single agent or in combination with other anti-cancer therapies in patients previously enrolled in a Hoffmann-l...
    Medical condition: Solid Tumours (Future parent protocols may include other solid tumors that are not included in this section)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065430 HER-2 positive breast cancer PT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066697 Ovarian cancer recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Ongoing) IT (Trial now transitioned) FR (Ongoing) PL (Completed) PT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-000329-11 Sponsor Protocol Number: Elderly Start Date*: 2018-05-02
    Sponsor Name:Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
    Full Title: Aflibercept and 5-FU vs. FOLFOX as 1st line treatment for elderly or frail elderly patients with metastatic colorectal cancer
    Medical condition: metastatic colorectal cancer
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052358 Colorectal cancer metastatic PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052362 Metastatic colorectal cancer LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-003024-20 Sponsor Protocol Number: HEMP-0119/ES Start Date*: 2019-10-15
    Sponsor Name:FAES FARMA SA
    Full Title: Multicenter, double-blind, randomized clinical trial to evaluate and compare the efficacy and safety of Hemorrane® Plus (Hemorrane® + benzocaine) with Hemorrane® and with placebo in patients with g...
    Medical condition: Bleeding grade I hemorrhoids
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2023-001004-33 Sponsor Protocol Number: CLCZ696B2319E2 Start Date*: 2025-01-20
    Sponsor Name:Novartis Pharmaceuticals
    Full Title: A Safety Study of Sacubitril/​Valsartan in Japanese Pediatric Patients With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction Who Have Completed CLCZ696B2319E1 Study
    Medical condition: Heart Failure
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10019280 Heart failures HLGT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-005406-96 Sponsor Protocol Number: AB20006 Start Date*: 2022-10-07
    Sponsor Name:AB Science
    Full Title: A 24-week, multicenter, randomized, double blind, placebo-controlled, dose-range finding phase II study to compare efficacy and safety of oral masitinib to placebo in treatment of patients with sev...
    Medical condition: severe mast cell activation syndrome (MCAS) with handicap unresponsive to optimal symptomatic treatment
    Disease: Version SOC Term Classification Code Term Level
    20.1 10005329 - Blood and lymphatic system disorders 10075217 Mast cell activation syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Prematurely Ended) BE (Prematurely Ended) DE (Prematurely Ended) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-001244-56 Sponsor Protocol Number: LiCTOP-C-001 Start Date*: 2013-07-23
    Sponsor Name:Department of Pharmacy, Uppsala University
    Full Title: An open, multicenter, single dose, parallel study, evaluating the pharmacokinetics of doxorubicin and its active metabolite (doxorubicinol) after a hepatic intra-arterial injection of either a lipi...
    Medical condition: Intermediate hepatocellular carcinoma
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004864 10019828 Hepatocellular carcinoma non-resectable LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2018-002522-23 Sponsor Protocol Number: T502-SIT-020 Start Date*: 2019-08-21
    Sponsor Name:Inmunotek S.L.
    Full Title: A prospective, randomized, double-blind placebo-controlled dose-finding study of different regimens of mannan-conjugated allergoids of birch pollen allergens administered subcutaneously to patients...
    Medical condition: Treatment of birch pollen-induced allergic rhinitis or rhinoconjunctivitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004853 10001728 Allergic rhinoconjunctivitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-002892-30 Sponsor Protocol Number: 1315.2 Start Date*: 2016-04-14
    Sponsor Name:Boehringer Ingelheim Pharma GmbH & Co. KG
    Full Title: An open-label, Phase I/II trial to determine the maximum tolerated dose and investigate safety, pharmacokinetics and efficacy of BI 836858 in combination with decitabine in patients with acute myel...
    Medical condition: patients with acute myeloid leukemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Ongoing) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-002046-16 Sponsor Protocol Number: MARS_2020 Start Date*: 2020-11-04
    Sponsor Name:Fakultní nemocnice Brno
    Full Title: A Randomised, double-blinded, placebo-controlled, multicenter study of efficacy, safety and side effects of highly diluted atropine collyrium in slowing the progression of myopia (shortsightedness)...
    Medical condition: Myopia in children
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-000898-83 Sponsor Protocol Number: ADN016 Start Date*: 2021-11-10
    Sponsor Name:ADIENNE SA
    Full Title: A phase II, randomized, double-blind, placebo-controlled, two-period, crossover trial to assess the efficacy and safety of begelomab in combination with standard steroid and/or immunosuppressant th...
    Medical condition: Dermatomyositis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10012503 Dermatomyositis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-008599-15 Sponsor Protocol Number: RV-MM-EMN-441 Start Date*: 2009-04-20
    Sponsor Name:FONDAZIONE NEOPLASIE SANGUE ONLUS
    Full Title: A PHASE 3, MULTICENTRE, RANDOMIZED, CONTROLLED STUDY TO DETERMINE THE EFFICACY AND SAFETY OF CYCLOPHOSPHAMIDE, LENALIDOMIDE AND DEXAMETHASONE (CRD) versus MELPHALAN (200 mg/m2) FOLLOWED BY STEM CEL...
    Medical condition: Multiple myeloma
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed) CZ (Completed) SK (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2017-004616-19 Sponsor Protocol Number: ABT-gpCPT001 Start Date*: 2018-09-12
    Sponsor Name:ASIT biotech S.A.
    Full Title: A dose-ranging clinical study to determine the range of grass pollen allergen (gpCPT+) concentrations to be used in a conjunctival provocation test to grade moderate to severe grass pollen allergic...
    Medical condition: This clinical trial aims to evaluate a conjunctival provocation test (CPT) with the IMP gpCPT+ for the assessment and grading of grass pollen allergic rhinoconjunctivitis. Thus, a diagnostic solu...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004853 10001728 Allergic rhinoconjunctivitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-000534-36 Sponsor Protocol Number: PR 1903 Start Date*: 2004-09-13
    Sponsor Name:Laboratoires Expanscience
    Full Title: Efficacy and Safety of Piascledine 300 versus Chondroitin Sulfate in a 6 Months Treatment plus 2 Months Observation in Patients with Osteoarthritis of the Knee
    Medical condition: Osteoarthritis of the Knee
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) HU (Completed) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-004766-26 Sponsor Protocol Number: NL58747 Start Date*: 2017-03-08
    Sponsor Name:Academic Medical Center
    Full Title: Intravenous immunoglobulins as early treatment in newly diagnosed idiopathic inflammatory myopathies (IMMEDIATE): a pilot study.
    Medical condition: idiopathic inflammatory myopathies
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-002323-35 Sponsor Protocol Number: TAK-669-3001 Start Date*: 2022-11-10
    Sponsor Name: Takeda Development Center Americas, Inc.
    Full Title: A Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Velaglucerase Alfa in Chinese Subjects With Type 1 Gaucher Disease
    Medical condition: Type 1 Gaucher Disease
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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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