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Clinical trials for Safety case

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   44334   clinical trials with a EudraCT protocol, of which   7366   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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    3,215 result(s) found for: Safety case. Displaying page 1 of 161.
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    EudraCT Number: 2012-005716-26 Sponsor Protocol Number: 110021 Start Date*: 2015-06-17
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, double blind (observer-blind), randomized, controlled multi-center study to evaluate, in infants and children, the efficacy of the RTS,S/AS01E candidate vaccine against malaria disease...
    Medical condition: Healthy volunteers (Primary and booster immunization against Plasmodium falciparum malaria)
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-000721-53 Sponsor Protocol Number: ITT-PMSExt Start Date*: 2012-12-07
    Sponsor Name:Dept of Neurology, Umeå University Hospital, Umeå, Sweden
    Full Title: ITT-PMS Extension An extension study of intrathecal therapy with monoclonal antibodies in progressive multiple sclerosis
    Medical condition: Secondary progressive multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10063400 Secondary progressive multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2006-000525-60 Sponsor Protocol Number: 750801.01.017 Start Date*: 2006-06-09
    Sponsor Name:Dr. Willmar Schwabe GmbH & Co. KG
    Full Title: Multi-center, double-blind, placebo-controlled, randomized phase III study to demonstrate the efficacy and investigate the safety of Hypericum extract WS® 5570 in patients with a Major Depressive E...
    Medical condition: Major depressive episode according to DSM-IV (single episode: 296.22, recurrent episode: 296.32; duration at least two weeks but not longer than one year).
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-017458-11 Sponsor Protocol Number: DEP-HOM Start Date*: 2010-06-10
    Sponsor Name:Institute for Social Medicine, Epidemiology, and Health Economics, Charité Berlin
    Full Title: Homeopathy for Depression: a randomized, four-armed, partial double-blind study.
    Medical condition: F32.1 Moderate Depressive Episode
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-002886-20 Sponsor Protocol Number: DHNS2013-01/MOHN01 Start Date*: 2014-01-30
    Sponsor Name:UMC St Radboud
    Full Title: A phase Ib-II study of the combination of cetuximab and methotrexate in recurrent or metastatic squamous cell carcinoma of the head and neck. A study of the Dutch Head and Neck Society.
    Medical condition: Recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2024-000442-10 Sponsor Protocol Number: A8081056 Start Date*: 2024-10-11
    Sponsor Name:Pfizer, Inc
    Full Title: CRIZOTINIB (XALKORI(REGISTERED)) EXPANDED ACCESS PROTOCOL FOR THE TREATMENT OF ADULT OR PEDIATRIC PATIENTS WITH SOLID OR HEMATOLOGIC MALIGNANCIES THAT HARBOR A CRIZOTINIB-SENSITIVE MOLECULAR ALTERA...
    Medical condition: Solid tumors
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-002966-41 Sponsor Protocol Number: APHP210639 Start Date*: 2021-08-13
    Sponsor Name:Assistance Publique – Hôpitaux de Paris / DRCI
    Full Title: Anti-Covid-19 vaccine protection in immunocompromised children (1-15 years) with acute leukemia and their siblings (≥ 12 years). Phase I-II trial evaluating safety and post-vaccination humoral and ...
    Medical condition: - Children aged 1-15 years with LA undergoing chemotherapy or whose last chemotherapy session date is less than or equal to 12 months. - Siblings of children with LA (living in the same household...
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000835 Acute leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-023185-42 Sponsor Protocol Number: S105AMCNilotinibSpA Start Date*: 2011-04-21
    Sponsor Name:Academic Medical Center, Division of Clinical Immunology and Rheumatology
    Full Title: Proof-of-concept double-blind, placebo-controlled, randomized clinical trial with nilotinib in spondyloarthritis
    Medical condition: Active axial and peripheral spondyloarthritis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-003087-20 Sponsor Protocol Number: 800_OPBG_2014 Start Date*: 2014-11-12
    Sponsor Name:IRCCS Ospedale Pediatrico Bambino Gesù
    Full Title: Determination of Plasmatic and CSF Levels Of High Doses Of Micafungin in Neonates Suffering from Systemic Candidiasis and/or Candida meningitis.
    Medical condition: Systemic Candidiasis and/or Candida Meningitis
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004862 10027238 Meningitis fungal NOS LLT
    17.0 100000004852 10027237 Meningeal fungal infections HLT
    17.0 100000004862 10042941 Systemic fungal infection NOS LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-000537-35 Sponsor Protocol Number: 07/2006 Start Date*: 2006-08-04
    Sponsor Name:Portuguese Lung Cancer Study Group
    Full Title: Open-label, Uncontrolled, Multicenter, Phase II study evaluating the efficacy and safety of Cetuximab in combination with Cisplatin & Gemcitabine as first-line therapy in patients with advanced non...
    Medical condition: Non small cell lung cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-004978-27 Sponsor Protocol Number: 1-2006 Start Date*: 2007-08-03
    Sponsor Name:Zentralklinikum St. Pölten
    Full Title: Initial Combination of Photodynamic Therapy with Verteporfin and Intravitreal Administration of Ranibizumab in Patients with Subfoveal Choroidal Neovascularisation due to Age-related Macular Degene...
    Medical condition: The case-series is designed to evaluate the safety and efficacy of intravitreal ranibizumab used in combination with verteporfin photodynamic therapy (Visudyne) for the treatment of subfoveal CNV s...
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-006652-22 Sponsor Protocol Number: AN08/8751 Start Date*: 2009-06-03
    Sponsor Name:Leeds Teaching Hospital NHS Trust
    Full Title: A multicentre, randomised, double blind, evaluative comparison trial of Rapydan® patch and Ametop® gel for topical anaesthesia during venous cannulation in adults admitted to hospital for day-case ...
    Medical condition: ASA 1 and 2 patients admitted for Day case surgery- assessment of cannulation pain after topical anaesthetic applications.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-001070-27 Sponsor Protocol Number: EP-PAE Metalyse Start Date*: 2005-07-07
    Sponsor Name:Division of Angiology Graz
    Full Title: Open, randomised, monosite pilot trial for comparison of thrombolytic efficacy of tenecteplase and alteplase in patients with acute pulmonary embolism
    Medical condition: Patients with acute pulmonary embolism and indication for thrombolytic therapy are included in the study
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2008-006765-82 Sponsor Protocol Number: MOXEP Start Date*: 2009-05-29
    Sponsor Name:ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI
    Full Title: Preventive therapy for multidrug-resistant tuberculosis: a multicentre clincal trial.
    Medical condition: Close contacts of an infectious respiratory of a MDR-TB who are diagnosed with tuberculosis infection that is likely to have been acquired from the MDR-TB case will be eligible for inclusion in th...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028440 HLGT
    9.1 10044756 HLT
    9.1 10021868 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-021792-81 Sponsor Protocol Number: 2010-12 Start Date*: Information not available in EudraCT
    Sponsor Name:ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
    Full Title: SFCE-Metro 01 : Etude de phase II de chimiothérapie métronomique associant celecoxib-methotrexate-vinblastine-cyclophosphamide chez les enfants porteurs d’une tumeur solide en rechute ou en progre...
    Medical condition: children and adolescents with relapsed or progressing solid tumours.
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-001118-15 Sponsor Protocol Number: APL-B-005-02 Start Date*: 2004-10-27
    Sponsor Name:Pharma Mar, S.A
    Full Title: Phase II multicenter,open-label, clinical and pharmacokinetic study of Aplidin® as a 3-hour infusion every 2 weeks, in patients with advanced or metastatic transitional cell carcinoma of the uroth...
    Medical condition: More than 90% of bladder carcinomas are transitional cell carcinomas (TCC) derived from the uroepithelium. About 6% to 8% are squamous cell carcinomas, and 2% are adenocarcinomas. Adenocarcinomas ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2004-005095-17 Sponsor Protocol Number: EA041999 Start Date*: 2005-02-10
    Sponsor Name:Engelhard Arzneimittel GmbH & Co. KG
    Full Title: Randomised, double-blind, placebo-controlled, monocentric phase III study on the efficacy and safety of Lidocaine 8 mg Sore Throat Lozenges in patients with moderate to severe acute sore throat not...
    Medical condition: The study will be performed in patients suffering from acute sore throat not necessarily to be treated with antibiotics
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-000904-39 Sponsor Protocol Number: MK-4482-013 Start Date*: 2021-08-11
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-4482 for the Prevention of COVID-19 (Laboratory-confirmed SARS-CoV-2 Infection W...
    Medical condition: Prophylaxis of 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: ES (Prematurely Ended) FR (Completed) HU (Completed) BG (Completed) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2021-004469-11 Sponsor Protocol Number: PP-SA-001 Start Date*: 2022-01-11
    Sponsor Name:PHERECYDES PHARMA
    Full Title: PhagoDAIR I: A Phase I/II Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Phage Therapy in Patients with Hip or Knee Prosthetic Joint Infection due to Staphylococcus ...
    Medical condition: knee or hip prosthetic joint infection (PJI) due to Staphylococcus aureus, with the indication of DAIR and Suppressive Antibiotics Therapy (SAT
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-001825-28 Sponsor Protocol Number: R119513 Start Date*: 2019-09-24
    Sponsor Name: The University of Manchester
    Full Title: Mesoangioblast-mediated exon 51 skipping for genetic correction of dystrophin, based upon a single injection in individual skeletal muscles of five non ambulant patients affected by Duchenne Muscul...
    Medical condition: Duchenne Muscular Dystrophy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Adolescents, Under 18 Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA)
    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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