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Clinical trials for Regulatory sequences

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   44335   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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    16 result(s) found for: Regulatory sequences. Displaying page 1 of 1.
    EudraCT Number: 2017-000852-24 Sponsor Protocol Number: 15/0552 Start Date*: 2017-08-23
    Sponsor Name:University College London (UCL)
    Full Title: A Phase I/II, Open label, Multicentre, Ascending Single Dose, Safety Study of a Novel Adeno-associated Viral Vector (FLT180a) in Patients With Haemophilia B
    Medical condition: Haemophilia B
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10018939 Haemophilia B (Factor IX) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-002095-40 Sponsor Protocol Number: B2151005 Start Date*: 2014-06-12
    Sponsor Name:Pfizer Inc.,235 East 42nd Street, New York, NY 10017
    Full Title: A RANDOMIZED PHASE 2 STUDY OF PF-05212384 PLUS IRINOTECAN VERSUS CETUXIMAB PLUS IRINOTECAN IN PATIENTS WITH KRAS AND NRAS WILD TYPE METASTATIC COLORECTAL CANCER
    Medical condition: Colorectal Cancer
    Disease: Version SOC Term Classification Code Term Level
    17.0 10018065 - General disorders and administration site conditions 10069755 K-ras gene mutation PT
    17.0 10018065 - General disorders and administration site conditions 10071972 N-ras gene mutation PT
    17.0 100000004864 10052362 Metastatic colorectal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) IT (Prematurely Ended) ES (Completed)
    Trial results: View results
    EudraCT Number: 2007-001036-31 Sponsor Protocol Number: A8361011 Start Date*: 2007-06-25
    Sponsor Name:Pfizer Limited, Ramsgate Road, Sandwich, Kent. UK. CT13 9NJ
    Full Title: A 2-COHORT, MULTI-CENTRE, RANDOMIZED, DOUBLE BLIND (3RD PARTY OPEN), PLACEBO CONTROLLED 4-WAY CROSSOVER STUDY TO ASSESS THE EFFICACY OF SINGLE ORAL DOSES OF PF-00446687 ON ERECTILE FUNCTION IN MEN ...
    Medical condition: Male erectile dysfunction (MED).
    Disease: Version SOC Term Classification Code Term Level
    9.1 10052003 Erectile dysfunction NOS LLT
    Population Age: Adults Gender: Male
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-003427-38 Sponsor Protocol Number: HGT-GCB-068 Start Date*: 2016-04-07
    Sponsor Name:Shire Human Genetic Therapies
    Full Title: A Multi-center, Open-label, Efficacy and Safety Study of Velaglucerase Alfa Enzyme Replacement Therapy in Children and Adolescents With Type 3 Gaucher Disease
    Medical condition: Type 3 Gaucher disease
    Disease: Version SOC Term Classification Code Term Level
    18.1 10010331 - Congenital, familial and genetic disorders 10075697 Gaucher's disease type I PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-002124-17 Sponsor Protocol Number: IMO-AFLI-2013-01 Start Date*: 2013-10-04
    Sponsor Name:Fundació de Recerca de L?Institut de Microcirurgia Ocular
    Full Title: Phase IV study to evaluate genetic variants of VEGF pathway as biomarkers of VEGF Trap-Eye treatment efficacy in subjects with neovascular age-related macular degeneration (wAMD).
    Medical condition: Wet age-related macular degeneration
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2016-000925-38 Sponsor Protocol Number: UCL13/0076 Start Date*: 2017-01-04
    Sponsor Name:University College London (UCL)
    Full Title: GO-8: Gene therapy for haemophilia A using a novel serotype 8 capsid pseudotyped adeno-associated viral vector encoding Factor VIII-V3
    Medical condition: Severe Haemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060612 Hemophilia A LLT
    20.0 100000004850 10060613 Hemophilia A (Factor VIII) LLT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2008-001965-27 Sponsor Protocol Number: HGT-GCB-044 Start Date*: 2008-10-29
    Sponsor Name:Shire Human Genetic Therapies, Inc.
    Full Title: An Open-Label Extension Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy in Patients with Type 1 Gaucher Disease
    Medical condition: Type I Gaucher disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018048 Gaucher's disease LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2020-001461-36 Sponsor Protocol Number: CT-AMT-130-02 Start Date*: 2021-06-30
    Sponsor Name:uniQure biopharma B.V.
    Full Title: A Phase Ib/II Randomised, Double-Blind Study to Explore Safety, Tolerability, and Efficacy Signals of Multiple Doses of Striatally-Administered rAAV5-miHTT Total Huntingtin Gene (HTT) Lowering Ther...
    Medical condition: Huntington Disease
    Disease: Version SOC Term Classification Code Term Level
    27.1 10010331 - Congenital, familial and genetic disorders 10070668 Huntington's disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: PL (Trial now transitioned) DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-000709-10 Sponsor Protocol Number: UKM12_0026 Start Date*: 2014-12-19
    Sponsor Name:Universitätsklinikum Münster
    Full Title: Alemtuzumab in Autoimmune Inflammatory Neurodegeneration: Mechanisms of Action and Neuroprotective Potential
    Medical condition: relapsing-remitting multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2022-002323-35 Sponsor Protocol Number: TAK-669-3001 Start Date*: 2022-11-10
    Sponsor Name: Takeda Development Center Americas, Inc.
    Full Title: A Multicenter, Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Velaglucerase Alfa in Chinese Subjects With Type 1 Gaucher Disease
    Medical condition: Type 1 Gaucher Disease
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-003611-62 Sponsor Protocol Number: LIB003-003 Start Date*: 2020-03-20
    Sponsor Name:LIB Therapeutics, LLC
    Full Title: Randomized, Open-Label, Cross-Over, Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 with Evolocumab in Homozygous Familial Hypercholesterolemia Patients on Stable Lipid-Lowering Therapy.
    Medical condition: Homozygous Familial Hypercholesterolemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10057080 Homozygous familial hypercholesterolemia LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-006304-11 Sponsor Protocol Number: TKT034 Start Date*: 2007-07-03
    Sponsor Name:Shire Human Genetic Therapies Inc
    Full Title: A multicenter open-label study of Gene-Activated Human Glucocerebrosidase (GA-GCB) enzyme replacement therapy in patients with type 1 Gaucher disease previously treated wiht imiglucerase
    Medical condition: Type I Gaucher Disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018048 Gaucher's disease LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-004888-31 Sponsor Protocol Number: 208750 Start Date*: 2020-01-27
    Sponsor Name:GlaxoSmithKline research & development Ltd.
    Full Title: Long-Term Follow-Up (LTFU) of Participants Treated with GSK Adoptive Cell Therapies
    Medical condition: Synovial sarcoma Multiple myeloma Non-small cell lung cancer Myxoid liposarcoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10042863 Synovial sarcoma PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028228 Multiple myeloma LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073137 Myxoid liposarcoma PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) SE (Completed) IT (Trial now transitioned) FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-002840-21 Sponsor Protocol Number: HGT-GCB-039 Start Date*: 2007-10-30
    Sponsor Name:Shire Human Genetic Therapies Inc
    Full Title: A Multicenter, Randomized, Double-Blind, Parallel-Group Study of Gene-Activated® Human Glucocerebrosidase (GA-GCB) Enzyme Replacement Therapy Compared with Imiglucerase in Patients with Type I Gauc...
    Medical condition: Type I Gaucher disease Enfermedad de Gaucher tipo 1
    Disease: Version SOC Term Classification Code Term Level
    9.1 10018048 Gaucher's disease LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) GB (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-001929-32 Sponsor Protocol Number: 2014/2126 Start Date*: 2014-08-25
    Sponsor Name:Gustave Roussy
    Full Title: Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication
    Medical condition: Diffuse Intrinsic Pontine Glioma
    Disease: Version SOC Term Classification Code Term Level
    17.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006143 Brain stem glioma PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DK (Trial now transitioned) SE (Trial now transitioned) GB (GB - no longer in EU/EEA) NL (Prematurely Ended) ES (Temporarily Halted)
    Trial results: (No results available)
    EudraCT Number: 2014-004842-92 Sponsor Protocol Number: SECOMBIT Start Date*: 2016-06-30
    Sponsor Name:FONDAZIONE MELANOMA ONLUS
    Full Title: A three arms prospective, randomized phase II study to evaluate the best sequential approach with combo immunotherapy (ipilimumab/nivolumab) and combo target therapy (LGX818/MEK162) in patients wit...
    Medical condition: Metastatic melanoma and BRAF mutation
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004864 10053571 Melanoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) ES (Ongoing) DE (Completed) GR (Completed) AT (Prematurely Ended) GB (GB - no longer in EU/EEA) SE (Completed) PL (Completed)
    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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