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Clinical trials for Marketing authorisation

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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    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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    91 result(s) found for: Marketing authorisation. Displaying page 1 of 5.
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    EudraCT Number: 2007-001152-39 Sponsor Protocol Number: SSG XX Start Date*: 2024-05-21
    Sponsor Name:Scandinavian Sarcoma Group
    Full Title: SSGXX A Scandinavian Sarcoma Group treatment protocol for adult patients with non-metastatic high-risk soft tissue sarcoma of the extremities and trunk wall
    Medical condition: SSG XX is a phase II trial for high-risk soft tissue sarcoma(STS) of the extremities and trunk wall. Prognostic markers are used to identify high-risk tumors. SSG XX will evaluate chemo-and radioth...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-004153-93 Sponsor Protocol Number: iEuroEwing Start Date*: 2022-06-17
    Sponsor Name:German Paediatric Oncology Group
    Full Title: INTERNATIONAL EURO EWING TRIAL FOR TREATMENT OPTIMISATION IN PATIENTS WITH EWING SARCOMA
    Medical condition: Ewing Sarcoma
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-002241-18 Sponsor Protocol Number: 983.974.742 Start Date*: 2023-03-14
    Sponsor Name:Helse Bergen HF
    Full Title: Diagnostic treatment-trial for autonomous cortisol secretion- a tool to select patients for adrenalectomy
    Medical condition: autonomous cortisol secretion
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-004927-12 Sponsor Protocol Number: 06-09-2006-0208-296-2401 Start Date*: 2009-11-20
    Sponsor Name:St Helier Hospital NHS Trust
    Full Title: A double-blind randomised placebo controlled study of cotrimoxazole in the treatment of advanced pulmonary fibrosis
    Medical condition: Advanced pulmonary fibrosis including common subtypes of usual interstitial pneumonitis and fibrotic non specific pneumonitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2008-007319-33 Sponsor Protocol Number: OP08/8679 Start Date*: 2009-02-19
    Sponsor Name:Leeds Teaching Hospitals NHS Trust
    Full Title: Do genes predict response to treatment in age-related macular degeneration?
    Medical condition: Choroidal neovascularisation secondary to age-related macular degeneration (ARMD)
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2004-000029-31 Sponsor Protocol Number: GIPF-007 Start Date*: 2005-01-28
    Sponsor Name:InterMune
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Safety and Efficacy of Interferon gamma-Ib in patients with Idiopathic Pulmonary Fibrosis The INSPIRE Trial - International Stu...
    Medical condition: Idiopathic Pulmonary Fibrosis (IPF)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-002898-19 Sponsor Protocol Number: IndiviStat#1 Start Date*: 2018-01-08
    Sponsor Name:Helsinki University Central Hospital
    Full Title: There is no English name for the trial.
    Medical condition: Primary prevention of atherosclerotic disease
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-000683-30 Sponsor Protocol Number: CoVacc Start Date*: 2021-03-03
    Sponsor Name:UmeƄ university
    Full Title: CoVacc - Immune response to vaccination against Covid-19, an open multicenter phase IV study
    Medical condition: Individuals with and without pre-existing immunity to Covid-19.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2017-005142-29 Sponsor Protocol Number: UC-0107/1718 Start Date*: 2018-08-30
    Sponsor Name:UNICANCER
    Full Title: PD-(L)1 iNhibitors with concurrent IRadiation at VAried tumour sites in advanced Non-small cell lung cAncer
    Medical condition: Advanced (stage IIIB/IIIC/IV) NSCLC patients eligible for treatment with a PD-1 or PD-L1 antagonist according to the European Marketing Authorisation in a first line or a second line
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-004743-23 Sponsor Protocol Number: CAPIT-001 Start Date*: 2013-12-10
    Sponsor Name:Hull and East Yorkshire Hospital Trust
    Full Title: A randomised controlled trial to assess the clinical and cost effectiveness of pre-operative skin cleansing with chlorhexidine and povidone-iodine in preventing surgical site infection and establis...
    Medical condition: Incidence of Surgical Site infection following clean or clean-contaminated, non-implant, vascular surgery
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10036410 Postoperative wound infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-000766-12 Sponsor Protocol Number: SCO/BIA-2093-301 Start Date*: 2005-03-21
    Sponsor Name:BIAL Portela & Companhia, S.A.
    Full Title: Efficacy and safety of BIA 2-093 as adjunctive therapy for refractory partial seizures in a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical trial
    Medical condition: About 40% of the patients suffering from epilepsy are not satisfactorily controlled and 25% suffer from significant adverse events. This lack of seizure control means that combination therapy is of...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2004-003814-40 Sponsor Protocol Number: FE200486 CS12A Start Date*: 2005-02-01
    Sponsor Name:Ferring Pharmaceuticals A/S
    Full Title: An open-label, multi-centre, extension study evaluation the long-term safety and tolerability of Degarelix one-month depots in patients with prostate cancer
    Medical condition: Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    7.0 10060862 pr t
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: HU (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-003168-63 Sponsor Protocol Number: AMLSG16-10/CPKC412ADE02T Start Date*: 2012-04-27
    Sponsor Name:University Hospital Ulm
    Full Title: Phase-II study evaluating midostaurin in induction, consolidation and maintenance therapy also after allogeneic blood stem cell transplantation in patients with newly diagnosed acute myeloid leuk...
    Medical condition: Patients with confirmed diagnosis of AML or related precursor neoplasm, or acute leukemia of ambiguous lineage (classified according to the World Health Organization (WHO) 2008 classification)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2009-016566-82 Sponsor Protocol Number: 05/SP/120 Start Date*: 2009-12-29
    Sponsor Name:Belfast Health and Social Care Trust [...]
    1. Belfast Health and Social Care Trust
    2. Queen's University Belfast
    Full Title: Skin bacteria as a source of surgical infections: molecular epidemiology and prevention of wound contaimination
    Medical condition: No medical condition under investigation, investigation of surgical wound contamination in spinal patients.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-002238-34 Sponsor Protocol Number: FFA-MAE-EXT Start Date*: 2021-03-22
    Sponsor Name:University Hospital Schleswig-Holstein (UKSH)
    Full Title: Open label extension study for monitoring long-term safety in patients with Myoclonic Astatic Epilepsy (Doose-Syndrome) receiving Fenfluramine as add-on therapy
    Medical condition: Childhood epilepsy: Myoclonic Astatic Epilepsy (Doose-Syndrome)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004850 10081183 Myoclonic-astatic epilepsy LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-000068-11 Sponsor Protocol Number: SAVDEX-12 Start Date*: 2012-05-16
    Sponsor Name:Turku University Hospital
    Full Title: The effects of dexmedetomidine on cerebral autoregulation and cerebral oxygenation in subarachnoid haemorrhage patients.
    Medical condition: This study will be conducted on aneurysmal subarachnoid hemorrhage patients.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-001817-35 Sponsor Protocol Number: 111958 Start Date*: 2021-08-04
    Sponsor Name:Radboud University Medical Center
    Full Title: Suboxone (buprenorphine/naloxone) versus methadone opioid rotation in patients with escalated opioid use and chronic pain: a randomized trial.
    Medical condition: Opioid use disorder
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-003218-36 Sponsor Protocol Number: 82646 Start Date*: 2023-06-05
    Sponsor Name:Radboudumc
    Full Title: The safety of ticagrelor monotherapy after primary percutaneous coronary intervention for ST-elevation myocardial infarction and the effect on intramyocardial haemorrhage
    Medical condition: Acute myocardial infarction
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-005547-17 Sponsor Protocol Number: RHMNUT0048 Start Date*: 2010-01-28
    Sponsor Name:Southampton University Hospital NHS Trust
    Full Title: Refeeding risks in patients requiring nutrition support. A twin centre double-blind randomised controlled trial of parenteral nutrition support.
    Medical condition: Patients who have a non-functioning gastrointestinal tract require artifical intravenous nutrition. This is usally a result recent surgery or sepsis causing a reversible short term paralysis of th...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2021-002634-16 Sponsor Protocol Number: NL76533.041.21 Start Date*: 2021-08-25
    Sponsor Name:University Medical Center Utrecht
    Full Title: Low dose cisplatin weekly versus high dose cisplatin every three weeks in primary chemoradiation in sarcopenic patients with head and neck squamous cell carcinoma
    Medical condition: The IMP will be used to treat locally advanced head and neck squamous cell carcinoma (HNSCC). Patients with low skeletal muscle mass will be randomized between two schedules: 1) weekly 40 mg/m2 cis...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
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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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