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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   44338   clinical trials with a EudraCT protocol, of which   7368   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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    27,968 result(s) found for: SAFETY. Displaying page 323 of 1,399.
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    EudraCT Number: 2016-003679-23 Sponsor Protocol Number: EPITOPE-V712-304 Start Date*: Information not available in EudraCT
    Sponsor Name:DBV TECHNOLOGIES S.A.
    Full Title: A double-blind, placebo-controlled, randomized phase III trial to assess the safety and efficacy of Viaskin® Peanut in peanut-allergic young children 1-3 years of age (EPITOPE study)
    Medical condition: Peanut allergy
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004870 10034202 Peanut allergy LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: IE (Completed) FR (Ongoing) DE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2022-002988-30 Sponsor Protocol Number: PROFIL-2088-SIM-0032-I Start Date*: 2023-04-19
    Sponsor Name:Klinikum rechts der Isar der Technischen Universität München
    Full Title: Double-blind, randomised, prospective, placebo controlled parallel group phase II study to investigate the effect of glycerol phenylbutyrate (GPB) on neurofilament light chain (NfL) levels in patie...
    Medical condition: Corticobasal Syndrome (CBS)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10078208 Corticobasal degeneration PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-004031-37 Sponsor Protocol Number: 17.14 Start Date*: 2017-12-07
    Sponsor Name:Department of oncology, Odense University Hospital
    Full Title: A multicentre, single-arm, phase II study to investigate the safety and antiemetic efficacy of Akynzeo® (a fixed dose combination of palonosetron and netupitant) plus dexamethasone in patients rece...
    Medical condition: Eligible patients will have a diagnosis of cervical cancer, and be scheduled to receive fractionated radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2 for at least five weeks. P...
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001872-13 Sponsor Protocol Number: PTC299-VIR-015-COV19 Start Date*: 2021-01-15
    Sponsor Name:PTC Therapeutics, Inc.
    Full Title: Evaluation of the efficacy and safety of PTC299 in hospitalized subjects with COVID-19 (FITE19)
    Medical condition: Coronavirus disease 2019 (COVID-19)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10066740 Acute respiratory tract infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Prematurely Ended) FR (Completed) BE (Completed) GR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-001936-23 Sponsor Protocol Number: BRAKE-AF Start Date*: 2018-09-21
    Sponsor Name:Dr. Adolfo Fontenla Cerezuela
    Full Title: A multicenter, randomized, open-label, phase III clinical trial to compare the efficacy and safety of Ivabradine versus Digoxine in the chronic control of heart rate in patients with permanent atri...
    Medical condition: Heart rate control in patients with chronic atrial fibrillation.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10071668 Permanent atrial fibrillation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2007-007157-31 Sponsor Protocol Number: Fibro 01/07 Start Date*: 2008-04-16
    Sponsor Name:Sahlgrenska Universitetssjukhuset
    Full Title: FIBRINOGEN AND BLEEDING AFTER CARDIAC SURGERY
    Medical condition: 60 patients undergoing coronary artery bypass surgery
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011077 Coronary artery bypass LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-003809-22 Sponsor Protocol Number: MDS Start Date*: 2022-09-09
    Sponsor Name:Karolinska University Hospital
    Full Title: A phase II multicenter single-armed study using subject-specific minimal residual disease markers to adopt treatment after allogeneic stem cell transplantation for subjects with myelodysplastic syn...
    Medical condition: Myelodysplastic syndrome (MDS)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned) FI (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-001460-11 Sponsor Protocol Number: 15/0599 Start Date*: 2016-06-30
    Sponsor Name:UCL CCTU
    Full Title: Corneal cross-linking versus standard care in children with keratoconus, a randomised, multicentre, observer-masked trial of efficacy and safety
    Medical condition: Patients with progressive keratoconus disease
    Disease: Version SOC Term Classification Code Term Level
    19.0 10015919 - Eye disorders 10023353 Keratoconus PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2016-004853-34 Sponsor Protocol Number: CT1401-B Start Date*: 2017-05-04
    Sponsor Name:Dalhousie University
    Full Title: A Phase 2 Randomized, Multi-Center Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of the V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine Candidate in HIV-Infected Adult...
    Medical condition: Ebola is caused by infection with a virus of the family Filoviridae, genus Ebolavirus. There are five identified Ebola virus species, four of which are known to cause disease in humans: Ebola virus...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10014074 Ebola virus infection LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2017-001553-14 Sponsor Protocol Number: BGB-290-103 Start Date*: 2018-06-29
    Sponsor Name:BeiGene USA, Inc.
    Full Title: A Phase 1b Study to Assess the Safety, Tolerability, and Clinical Activity of BGB-290 in Combination with Temozolomide (TMZ) in Subjects with Locally Advanced or Metastatic Solid Tumors
    Medical condition: Locally Advanced or Metastatic Solid Tumors (ovarian cancer, triple negative breast cancer (TNBC), metastatic castration-resistant prostate cancer (mCRPC), small cell lung cancer (SCLC), and gastri...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2020-004504-33 Sponsor Protocol Number: BAT-2206-002-CR Start Date*: 2021-07-20
    Sponsor Name:Bio-Thera Solutions, Ltd.
    Full Title: A Multicenter, Randomized, Double-Blind, Parallel-Arm, Phase 3 Study to Compare Efficacy and Safety of BAT2206 with Stelara® in Patients with Moderate to Severe Plaque Psoriasis
    Medical condition: Moderate to Severe Plaque Psoriasis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10040785 Skin and subcutaneous tissue disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed)
    Trial results: View results
    EudraCT Number: 2016-001569-97 Sponsor Protocol Number: AGO/2016/004 Start Date*: 2017-06-19
    Sponsor Name:University Hospital Ghent
    Full Title: A phase II Investigation of Pembrolizumab (Keytruda) in combination with radiation and an immune modulatory cocktail in patients with cervical and uterine cancer.
    Medical condition: cervical cancer, endometrial carcinoma, uterine sarcoma
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2019-002618-38 Sponsor Protocol Number: 721 Start Date*: 2020-06-25
    Sponsor Name:ASSOCIAZIONE "LA NOSTRA FAMIGLIA" - SEZIONE SCIENTIFICA I.R.C.C.S. "E.MEDEA"
    Full Title: Clinical trial - phase II - to test safety and efficay of Etravirine's treatment in Friedreich Ataxia's patients
    Medical condition: Friedreich's ataxia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10017374 Friedreich's ataxia PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-005058-27 Sponsor Protocol Number: 165-306 Start Date*: Information not available in EudraCT
    Sponsor Name:BioMarin Pharmaceutical Inc.
    Full Title: A Phase 3 Multi-Center Study to Evaluate the Safety and Efficacy of Subcutaneous Injections of Pegvaliase in Adolescent Subjects (Ages 12-17) with Phenylketonuria Featuring an Open-Label Randomized...
    Medical condition: Phenylketonuria (PKU)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10034873 Phenylketonuria (PKU) LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-002766-14 Sponsor Protocol Number: 2020-3093 Start Date*: 2020-10-26
    Sponsor Name:Gustave Roussy
    Full Title: An open label phase II basket trial exploring the efficacy and safety of the combination of Niraparib and Dostarlimab in patients with DNA repair-deficient or platinum-sensitive solid tumors
    Medical condition: Patients with DNA repair-deficient or platinum-sensitive solid tumors
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-002197-31 Sponsor Protocol Number: AFAMOSI Start Date*: 2020-05-12
    Sponsor Name:Universitätsmedizin Mainz, Interdisziplinäres Zentrum klinische Studien
    Full Title: AFAMOSI: Prospective, randomized, multicenter Phase IV study to evaluate the efficacy and safety of afatinib followed by osimertinib compared to osimertinib in patients with EGFRmutated/T790M Mutat...
    Medical condition: EGFR mutated non-squamous NSCLC
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10038666 Respiratory and mediastinal neoplasms malignant and unspecified HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-004246-35 Sponsor Protocol Number: TAK-675-3001 Start Date*: 2024-06-10
    Sponsor Name:Takeda Development Center Americas, Inc
    Full Title: An Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of REPLAGAL® in Treatment-naïve Chinese Subjects with Fabry Disease
    Medical condition: Fabry Disease
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-006885-19 Sponsor Protocol Number: ARQ-151-313 Start Date*: Information not available in EudraCT
    Sponsor Name:Arcutis Biotherapeutics, Inc.
    Full Title: A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.15% and ARQ-151 Cream 0.05% in Subjects with Atopic Dermatitis
    Medical condition: Atopic Dermatitis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10040785 - Skin and subcutaneous tissue disorders 10003639 Atopic dermatitis LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005299-36 Sponsor Protocol Number: EXEVIR0101 Start Date*: 2021-04-21
    Sponsor Name:ExeVir Bio BV
    Full Title: A 2-part Clinical Study Including a First-in-Human, Open-label, Single Ascending Dose Part (Phase 1) Followed by a Randomised, Double-blind, Placebo-controlled Part (Phase 2) to Evaluate the Effica...
    Medical condition: Subjects hospitalised for COVID 19
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004862 10084382 Coronavirus disease 2019 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) PT (Prematurely Ended) IT (Prematurely Ended) RO (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-000132-25 Sponsor Protocol Number: CA224-083 Start Date*: 2020-10-26
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab Administered in Combination with Ipilimumab or Ipilimumab Alone in Participants with Unresectable or Metastatic ...
    Medical condition: Melanoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027481 Metastatic melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (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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