Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Informed assent

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   44341   clinical trials with a EudraCT protocol, of which   7370   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.
    How to search [pdf]
    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.
    Advanced Search: Search tools
     
    2,426 result(s) found for: Informed assent. Displaying page 1 of 122.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    EudraCT Number: 2015-002177-37 Sponsor Protocol Number: 1321.7 Start Date*: 2016-06-01
    Sponsor Name:Boehringer Ingelheim AB
    Full Title: Single dose, open label, uncontrolled, safety trial of intravenous administration of idarucizumab to paediatric patients enrolled from ongoing phase IIb/III clinical trials with dabigatran etexilat...
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004866 10066899 Venous thromboembolism LLT
    18.1 100000004865 10049909 Venous thromboembolism prophylaxis LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed) LT (Completed) CZ (Completed) IT (Completed) DE (Completed) Outside EU/EEA GR (Completed) HU (Completed) BE (Completed) ES (Prematurely Ended) BG (Completed) AT (Completed) FI (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2023-000765-14 Sponsor Protocol Number: 217270 Start Date*: 2023-10-03
    Sponsor Name:GlaxoSmithKline Biologicals SA
    Full Title: A prospective, multi-center post marketing surveillance (PMS) study to monitor the safety of GlaxoSmithKline Biologicals’ SA’s (GSK) Meningococcal Group B (Bexsero) vaccine in Korean participants, ...
    Medical condition: The study will collect real-world post-vaccination adverse events.
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2014-003609-14 Sponsor Protocol Number: ZLB07_001CR Start Date*: 2015-01-05
    Sponsor Name:CSL Behring
    Full Title: A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency
    Medical condition: Primary Immune Deficiency
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-002513-27 Sponsor Protocol Number: 200862 Start Date*: 2014-11-19
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A randomised, double-blind, placebo-controlled, parallel-group, multi-centre 24-week study to evaluate the efficacy and safety of mepolizumab adjunctive therapy in subjects with severe eosinophilic...
    Medical condition: Subjects with severe asthma
    Disease: Version SOC Term Classification Code Term Level
    17.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) SK (Completed) BE (Completed) DE (Completed) CZ (Completed) GR (Completed) EE (Completed) ES (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2014-000424-23 Sponsor Protocol Number: 331-13-211 Start Date*: 2014-10-31
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A 2-month, Observational, Rollover Trial to Evaluate the Safety of Subjects with Agitation Associated with Dementia of the Alzheimer?s Type who were Previously Treated with Brexpiprazole (OPC-34712...
    Medical condition: Agitation Associated with Dementia of the Alzheimer's Type
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) SI (Completed) FR (Completed) GB (Completed) HR (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2008-005237-30 Sponsor Protocol Number: REMICADEPIB4002 Start Date*: 2009-12-01
    Sponsor Name:Janssen Biologics B.V.
    Full Title: A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease or Ulcerative Colitis
    Medical condition: Pediatric patients with a confirmed diagnosis of CD or UC .
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004856 10013099 Disease Crohns LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing) SE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-000369-44 Sponsor Protocol Number: 111375 Start Date*: 2009-03-24
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A long-term, open follow-up of the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 VLP/AS04 vaccine in healthy female subjects up to 10 years after administration of the first v...
    Medical condition: For the prevention of high-grade cervical intraepithelial neoplasia (CIN grades 2 and 3) and cervical cancer causally related to human papillomavirus (HPV) types 16 and 18.
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-016911-39 Sponsor Protocol Number: 113954 Start Date*: 2010-05-05
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: An open, phase IV, multicentre, study to assess the long-term persistence of antibodies against hepatitis B and the immune response to a hepatitis B vaccine challenge in healthy children aged 11-12...
    Medical condition: Antibody persistence and hepatitis B vaccine challenge at 11-12 years of age (excluding 13th birthday), after primary vaccination with GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) or G...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SK (Completed)
    Trial results: View results
    EudraCT Number: 2009-016268-35 Sponsor Protocol Number: 113883 Start Date*: 2009-12-09
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, randomized, observer blind study to evaluate the safety and immunogenicity of three different vaccination schedules employing two formulations of the monovalent A/California/7/2009 (H1N...
    Medical condition: Immunization of healthy children aged 10 to less than 18 years against A/California/7/2009 (H1N1)v-like influenza
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SK (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2020-004980-24 Sponsor Protocol Number: mRNA-3705-P101 Start Date*: 2023-08-21
    Sponsor Name:ModernaTX, Inc.
    Full Title: A Global, Phase 1/2, Open-Label, Dose Optimization Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of mRNA-3705 in Participants with Isolated Methylmalonic Acidem...
    Medical condition: Isolated Methylmalonic Acidemia Due to Methylmalonyl-CoA Mutase Deficiency
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) FR (Trial now transitioned) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-003597-18 Sponsor Protocol Number: 18F-AV-45-010 Start Date*: 2009-05-28
    Sponsor Name:Avid Radiopharmaceuticals, Inc
    Full Title: A study evaluating the imaging characteristics of 18F-AV-45 in patients with frontotemporal dementia compared to patients with Alzheimer's disease and normal controls
    Medical condition: Use of 18F-AV-45 positron emission tomography as early diagnostic technique in frontal lobe dementia and Alzheimer's disease.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10022891 - Investigations 10061816 Diagnostic procedure PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-013272-47 Sponsor Protocol Number: iSPOT-A Start Date*: 2009-08-19
    Sponsor Name:BRC operations Pty. Ltd
    Full Title: International Study to Predict Optimized Treatment - in Attention-Deficit and Hyperactivity Disorder
    Medical condition: Attention Deficit Hyperactivity Disorder
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2023-000463-32 Sponsor Protocol Number: CB-03-01/25 Start Date*: 2023-04-19
    Sponsor Name:CASSIOPEA SpA
    Full Title: A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Cream, 1% Applied Twice Daily for 12 Weeks in...
    Medical condition: Facial Acne Vulgaris
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004858 10000519 Acne vulgaris LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2023-000462-33 Sponsor Protocol Number: 171-7151-202 Start Date*: 2023-04-19
    Sponsor Name:Intrepid Therapeutics, Inc.
    Full Title: An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Every 12 Hours for Two Weeks in Subjects with Acn...
    Medical condition: Facial Acne Vulgaris
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2023-000461-13 Sponsor Protocol Number: 171-7151-201 Start Date*: 2023-04-19
    Sponsor Name:Intrepid Therapeutics Inc.
    Full Title: A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Dose Escalating Study to Evaluate the Safety and Efficacy of Cortexolone 17α-Propionate (CB-03-01) Cream Applied Once or Twice-...
    Medical condition: Facial Acne Vulgaris
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004945-10 Sponsor Protocol Number: E2007-J000-341 Start Date*: 2017-08-30
    Sponsor Name:Eisai Co., ltd
    Full Title: An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects
    Medical condition: Epilepsy
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004103-73 Sponsor Protocol Number: 0881A1-207 Start Date*: 2015-03-12
    Sponsor Name:Wyeth Kabushiki Kaisha (Wyeth K.K.)
    Full Title: A long-term, open-label study of TNR-001 in Japanese Juvenile Idiopathic Arthritis Subjects.
    Medical condition: Juvenile idiopathic arthritis (JIA)
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-001288-99 Sponsor Protocol Number: C4221015 Start Date*: 2020-11-26
    Sponsor Name:Pfizer Inc.
    Full Title: AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE 3 STUDY OF FIRST LINE ENCORAFENIB PLUS CETUXIMAB WITH OR WITHOUT CHEMOTHERAPY VERSUS STANDARD OF CARE THERAPY WITH A SAFETY LEAD-IN OF ENCORAFENIB AND C...
    Medical condition: Colorectal cancer (BRAF V600E-mutant mCRC)
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned) GB (GB - no longer in EU/EEA) NL (Ongoing) DE (Ongoing) FR (Not Authorised) BE (Trial now transitioned) SE (Trial now transitioned) IT (Trial now transitioned) PL (Trial now transitioned) SK (Trial now transitioned) BG (Trial now transitioned) FI (Trial now transitioned) DK (Trial now transitioned) CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-003715-26 Sponsor Protocol Number: C4221022 Start Date*: 2022-05-10
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND CETUXIMAB PLUS PEMBROLIZUMAB VERSUS PEMBROLIZUMAB ALONE IN PARTICIPANTS WITH PREVIOUSLY UNTREATED BRAF V600E-MUTANT, MSI-H/DMMR METASTATIC...
    Medical condition: MSI-H/dMMR metastatic colorectal cancer.
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10052358 Colorectal cancer metastatic PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) NO (Trial now transitioned) DE (Trial now transitioned) ES (Ongoing) SE (Trial now transitioned) BE (Trial now transitioned) SK (Trial now transitioned) IT (Trial now transitioned) DK (Trial now transitioned) NL (Trial now transitioned) PL (Trial now transitioned) CZ (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-019180-10 Sponsor Protocol Number: NCTU5248 Start Date*: 2010-07-29
    Sponsor Name:The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Full Title: Paramedic Initiated Lisinopril For Acute Stroke Treatment(PIL-FAST): A Pilot Randomised Controlled Trial
    Medical condition: Stroke and high blood pressure
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    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.
    1  2  3  4  5  6  7  8  9  Next» Last»»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Mon Jun 09 11:28:25 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA