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Clinical trials for Drug Approval

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    533 result(s) found for: Drug Approval. Displaying page 1 of 27.
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    EudraCT Number: 2017-001678-40 Sponsor Protocol Number: CACZ885N2301E2 Start Date*: 2017-05-15
    Sponsor Name:Novartis pharma AG
    Full Title: An extension study of safety of canakinumab in Japanese patients with periodic fever syndromes
    Medical condition: Three disease of periodic fever syndromes, TNF receptor Associated Periodic Syndrome (TRAPS), Hyper IgDSyndrome (HIDS)/ Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean Fever (FMF
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10010331 Congenital, familial and genetic disorders SOC
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-005103-39 Sponsor Protocol Number: AP01-005 Start Date*: 2021-04-16
    Sponsor Name:Avalyn Pharma, Inc.
    Full Title: Access to Pirfenidone Solution for Inhalation (AP01) for Treatment of Progressive, Fibrosing Interstitial Lung Diseases, including Idiopathic Pulmonary Fibrosis
    Medical condition: Interstitial Lung Diseases (ILD), including but not limited to idiopathic pulmonary fibrosis (IPF)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10022611 Interstitial lung disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Ongoing) NL (Ongoing) PL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-004335-39 Sponsor Protocol Number: N01223 Start Date*: 2015-02-16
    Sponsor Name:UCB Japan Co. Ltd.
    Full Title: An Open Label, Single-Arm, Multi-Center Study on the Efficacy, Safety and Pharmacokinetics of Levetiracetam in Pediatric Patients (4 to 16 Years) With Partial Seizures Despite Treatment With 1 or 2...
    Medical condition: Epilepsy Partial Seizures
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029205 - Nervous system disorders 10015037 Epilepsy PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-000954-67 Sponsor Protocol Number: ATB200-07 Start Date*: 2020-04-08
    Sponsor Name:Amicus Therapeutics, Inc.
    Full Title: A Phase 3 Open-label Extension Study to Assess the Long-term Safety and Efficacy of Intravenous ATB200 Co-administered With Oral AT2221 in Adult Subjects With Late-onset Pompe Disease
    Medical condition: Adult Subjects With Late Onset Pompe Disease (LOPD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10075702 Pompe's disease late onset LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Ongoing) DE (Completed) DK (Ongoing) FR (Ongoing) BE (Ongoing) GR (Ongoing) SI (Ongoing) AT (Completed) IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-006076-38 Sponsor Protocol Number: RLBUHT3173 Start Date*: 2007-04-26
    Sponsor Name:University of Liverpool [...]
    1. University of Liverpool
    2. Royal Liverpool & Broadgreen University Hospitals Trust
    Full Title: The Liverpool HIV TDM Registry: Studying influences upon plasma HIV drug exposure
    Medical condition: Pharmacogenetic study of HIV+ patients receiving antiretroviral therapy. We wish to correlate drug concentration with host genetic patients receiving certain HIV drugs. No dosage modification wil...
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-001046-17 Sponsor Protocol Number: SMART-2019 Start Date*: 2019-05-02
    Sponsor Name:Uppsala University
    Full Title: A multicentre, register-based, randomized, controlled trial comparing dapagliflozin with metformin treatment in early stage type 2 diabetes patients by assessing mortality and macro- and microvascu...
    Medical condition: Type 2 Diabetes
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-002996-34 Sponsor Protocol Number: PK 2005 xx Start Date*: 2006-04-27
    Sponsor Name:University Hospitals of Leicester NHS Trust
    Full Title: Pharmacokinetics of actinomycin D in children with cancer
    Medical condition: Any children's cancer where this drug is administered as part of the treatment regimen
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-001018-13 Sponsor Protocol Number: BCX1812-305 Start Date*: 2021-03-31
    Sponsor Name:BioCryst Pharmaceuticals Inc
    Full Title: A Phase 3, Randomized, Open Label, Active-controlled Study to Evaluate the Safety, Pharmacokinetics and Effectiveness of IV Peramivir Compared to Oral Oseltamivir in Pediatric Subjects With Acute U...
    Medical condition: acute uncomplicated influenza
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-019866-96 Sponsor Protocol Number: IPM3001 Start Date*: 2010-12-07
    Sponsor Name:ZIOPHARM Oncology Inc
    Full Title: A Phase III multicenter, international, randomized, double-blind, placebo-controlled study of doxorubicin plus palifosfamide-tris vs. doxorubicin plus placebo in patients with front-line metastatic...
    Medical condition: metastatic soft tissue sarcomas, previously untreated
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) GB (Prematurely Ended) ES (Ongoing) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-005396-25 Sponsor Protocol Number: D3250C00037 Start Date*: 2016-06-22
    Sponsor Name:AstraZeneca AB
    Full Title: A Multicenter, Open-label, Safety Extension Study with Benralizumab (MEDI-563) for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist (MELTEMI)
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed) DE (Completed) CZ (Completed) PL (Completed) BG (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-004129-18 Sponsor Protocol Number: AK581 Start Date*: 2017-03-17
    Sponsor Name:Akari Therapeutics Plc
    Full Title: CONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study
    Medical condition: Paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10005329 - Blood and lymphatic system disorders 10018932 Haemolytic uraemic syndrome PT
    21.1 10038359 - Renal and urinary disorders 10034042 Paroxysmal nocturnal haemoglobinuria PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) PL (Prematurely Ended) NL (Prematurely Ended) LT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-001768-60 Sponsor Protocol Number: CNS 2007 04 Start Date*: 2007-10-01
    Sponsor Name:University of Birmingham
    Full Title: A Phase II Multi-Centre Study of Concomitant and Prolonged Adjuvant Temozolomide with Radiotherapy in Diffuse Pontine Gliomas
    Medical condition: Diffuse pontine glioma in children
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006143 Brain stem glioma PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-002880-42 Sponsor Protocol Number: LAL-CL05 Start Date*: 2011-12-05
    Sponsor Name:Synageva Biopharma Corp.
    Full Title: An Open Label Multicenter Extension Study to Evaluate the Long-Term Efficacy and Safety of SBC 102 in Children with Lysosomal Acid Lipase Deficiency Who Previously Received Treatment with SBC-102
    Medical condition: Growth failure in children due to lysosomal acid lipase deficiency (Wolman disease).
    Disease: Version SOC Term Classification Code Term Level
    14.0 10027433 - Metabolism and nutrition disorders 10027433 Metabolism and nutrition disorders SOC
    14.0 10027433 - Metabolism and nutrition disorders 10021605 Inborn errors of metabolism HLGT
    14.0 10010331 - Congenital, familial and genetic disorders 10024579 Lysosomal storage disorders HLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003916-19 Sponsor Protocol Number: 001 Start Date*: 2015-12-30
    Sponsor Name:Karl Landsteiner Institut für klinische Neurologie und Neuropsycholigie
    Full Title: Perioperative Levetiracetam for seizure prophylaxis in brain tumor patients. Prospective evaluation of side effects and efficacy
    Medical condition: Data on perioperative seizure prophylaxis in brain tumor patients as weil as on specific side effects is limited in scientific literature. Epileptic seizures during and after brain tumor surgery ma...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-001319-30 Sponsor Protocol Number: CH/2011/3670 Start Date*: 2012-04-04
    Sponsor Name:University Hospitals Bristol NHS Foundation Trust
    Full Title: A randomized, double-blind, parallel group, placebo-controlled trial of metformin in tuberous sclerosis complex.
    Medical condition: Tuberous Sclerosis Complex
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10045138 Tuberous sclerosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-000788-27 Sponsor Protocol Number: RD01273 Start Date*: 2006-04-20
    Sponsor Name:Royal United Hospital Bath NHS Trust
    Full Title: International Collaborative Infantile Spasms Study (ICISS)
    Medical condition: Infantile spasms are a rare severe form of epilepsy affecting approx 1 in 2,250 infants, usually under the age of 1 year. Affected infants have a very abnormal EEG and a poor prognosis for subseque...
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-000451-41 Sponsor Protocol Number: HO150 Start Date*: 2019-03-01
    Sponsor Name:HOVON Foundation
    Full Title: A phase 3, multicenter, double-blind, randomized, placebo-controlled study of ivosidenib or enasidenib in combination with induction therapy and consolidation therapy followed by maintenance therap...
    Medical condition: AML or MDS-EB2 with a mutation in either IDH1 or IDH2
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001941 AML LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10068361 MDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing) FI (Ongoing) LT (Ongoing) SE (Ongoing) BE (Ongoing) FR (Temporarily Halted) NO (Ongoing) IE (Ongoing) DE (Ongoing) AT (Ongoing) DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-004522-16 Sponsor Protocol Number: DU176b-C-U301 Start Date*: 2009-05-20
    Sponsor Name:Daiichi Sankyo Pharma Development
    Full Title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL GROUP, MULTI-CENTER, MULTI-NATIONAL STUDY FOR EVALUATION OF EFFICACY AND SAFETY OF DU-176B VERSUS WARFARIN IN SUBJECTS WITH ATRIAL FIBRIL...
    Medical condition: Reduction of Stroke and/or systemic embolic event (SEE) in subjects with atrial fibrillation (AF).
    Disease: Version SOC Term Classification Code Term Level
    14.1 10007541 - Cardiac disorders 10003658 Atrial fibrillation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) GB (Completed) SE (Completed) EE (Completed) FI (Completed) NL (Completed) PT (Completed) DK (Completed) ES (Completed) CZ (Completed) IT (Completed) BG (Completed) HU (Completed) SK (Completed) GR (Completed)
    Trial results: View results
    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 (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-002845-36 Sponsor Protocol Number: PK200609 Start Date*: 2006-11-14
    Sponsor Name:Newcastle upon Tyne Hospitals NHS Foundation Trust
    Full Title: Pharmacokinetics and pharmacogenetics of anticancer drugs in infants and young children
    Medical condition: Any childhood cancer.
    Disease:
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (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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