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Clinical trials for Genetic engineering

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   44336   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 ).  
     
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    16 result(s) found for: Genetic engineering. Displaying page 1 of 1.
    EudraCT Number: 2007-002773-30 Sponsor Protocol Number: 552007 Start Date*: 2007-10-15
    Sponsor Name:Herz-, Thorax- und Gefäßchirurgische Anästhesie und Intensivmedizin
    Full Title: Subcutaneous insulin therapy of hyperglycemia after initiation of oral intake in the ICU
    Medical condition: Hyperglycemia is very common in hospitalized, critically ill patients and is associated with higher mortality and morbidity. Careful monitoring and therapy of hyperglycemia have become standard in...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10042216 Stress induced hyperglycemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-001590-29 Sponsor Protocol Number: 022007 Start Date*: 2007-07-06
    Sponsor Name:Herz-, Thorax- und Gefäßchirurgische Anästhesie und Intensivmedizin
    Full Title: Insulin aspart (NovoRapid®, Novo Nordisk) vs. human insulin (Actrapid®, Novo Nordisk) in intravenous treatment of high blood glucose concentrations in the ICU
    Medical condition: Therapy of hyperglycemia by intravenously applied insulin is going to be investigated. Hyperglycemia is very common in hospitalized, critically ill patients, even if they have not previously had di...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10042216 Stress induced hyperglycemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-003793-26 Sponsor Protocol Number: 3066K1-3311-WW Start Date*: 2008-05-19
    Sponsor Name:Wyeth Research Division of Wyeth Pharmaceuticals Inc.
    Full Title: Phase 3b, Randomized, Open-Label Study of Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa as First-Line Treatment in Subjects With Advanced Renal Cell Carcinoma
    Medical condition: First-Line Treatment in Subjects with Advanced Renal Cell Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    9.1 10050513 Metastatic renal cell carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed) FR (Completed) BE (Completed) PT (Completed) CZ (Completed) DE (Completed) SK (Completed) NL (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-002802-34 Sponsor Protocol Number: Sandoz/OMNI/F/01/03 Start Date*: 2015-07-03
    Sponsor Name:Sandoz SAS
    Full Title: Multicentre study to evaluate the efficacy and safety of a liquid formulation of recombinant growth hormone, Omnitrope® 3.3mg/mL, in the treatment of pre-pubertal children of small stature sufferin...
    Medical condition: Small stature secondary to growth hormone insufficiency deficiency
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-001840-20 Sponsor Protocol Number: CTBM100C2412 Start Date*: 2016-05-18
    Sponsor Name:Novartis Pharmaceuticals Corporation
    Full Title: A Multi-center, Human Factors Engineering (HFE) Usability Study in Cystic Fibrosis Patients to Validate the Approved Instructions for Use (IFU) of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Usi...
    Medical condition: cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-015985-75 Sponsor Protocol Number: HGT-REP-060 Start Date*: 2010-02-03
    Sponsor Name:Shire Human Genetic Therapies (HGT), Inc.
    Full Title: An Open-label Extension of Study TKT028 Evaluating Safety and Clinical Outcomes of Replagal Enzyme Replacement Therapy Administered to Adult Patients with Fabry Disease
    Medical condition: Fabry disease
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed) CZ (Completed) GB (Completed) FI (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2010-021348-16 Sponsor Protocol Number: HGT-SAN-067 Start Date*: 2011-02-09
    Sponsor Name:Shire Human Genetic Therapies, Inc
    Full Title: An Open-Label Extension of Study HGT-SAN-055 Evaluating Long Term Safety and Clinical Outcomes of Intrathecal Administration of rhHNS in Patients with Sanfilippo Syndrome Type A (MPS IIIA)
    Medical condition: Sanfilippo Syndrome Type A or Mucopolysaccharidosis (MPS IIIA)
    Disease: Version SOC Term Classification Code Term Level
    19.1 10010331 - Congenital, familial and genetic disorders 10056918 Sanfilippo's syndrome LLT
    19.1 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) NL (Completed)
    Trial results: View results
    EudraCT Number: 2007-005543-22 Sponsor Protocol Number: TKT028 Start Date*: 2008-06-19
    Sponsor Name:Shire Human Genetic Therapies, Inc. (Shire HGT)
    Full Title: A Multi-center, Open-Label, Randomized Study Evaluating the Safety and Efficacy of Three Dosing Regimens of Replagal Enzyme Replacement Therapy in Adult Patients with Fabry Disease
    Medical condition: Fabry Disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) GB (Completed) FI (Completed) SI (Completed)
    Trial results: View results
    EudraCT Number: 2014-003960-20 Sponsor Protocol Number: SHP-610-201 Start Date*: 2015-02-18
    Sponsor Name:Shire human Genetic Therapies, Inc.
    Full Title: A Open-Label Extension of Study HGT-SAN-093 Evaluating the Safety and Efficacy Study of HGT-1410 (Recombinant Human Heparan N Sulfatase) Administration via an Intrathecal Drug Delivery Device in...
    Medical condition: Sanfilippo Syndrome Type A or Mucopolysaccharidosis (MPS IIIA)
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10056918 Sanfilippo's syndrome LLT
    17.1 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) DE (Prematurely Ended) NL (Completed) GB (Prematurely Ended) FR (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-022709-16 Sponsor Protocol Number: AT1001-013 Start Date*: 2011-09-12
    Sponsor Name:Amicus Therapeutics, Inc.
    Full Title: AN OPEN-LABEL PHASE 2A STUDY TO INVESTIGATE DRUG-DRUG INTERACTIONS BETWEEN AT1001 (MIGALASTAT HYDROCHLORIDE) AND AGALSIDASE IN SUBJECTS WITH FABRY DISEASE
    Medical condition: Fabry disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Adults Gender: Male
    Trial protocol: BE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-022636-37 Sponsor Protocol Number: AT1001-012 Start Date*: 2011-01-18
    Sponsor Name:Amicus Therapeutics, Inc.
    Full Title: A RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF AT1001 AND ENZYME REPLACEMENT THERAPY (ERT) IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS, WHO WERE PREVIOU...
    Medical condition: Fabry disease
    Disease: Version SOC Term Classification Code Term Level
    16.1 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) DK (Completed) AT (Completed) GR (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-015984-15 Sponsor Protocol Number: HGT-SAN-055 Start Date*: 2010-03-25
    Sponsor Name:Shire Human Genetic Therapies, Inc. (Shire HGT)
    Full Title: A Phase I/II Safety, Tolerability, Ascending Dose and Dose Frequency Study of Recombinant Human Heparan-N-sulfatase (rhHNS) Intrathecal Administration via an Intrathecal Drug Delivery Device in Pat...
    Medical condition: Sanfilippo Syndrome Type A or Mucopolysaccharidosis (MPS IIIA)
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    14.0 10010331 - Congenital, familial and genetic disorders 10056918 Sanfilippo's syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-001174-30 Sponsor Protocol Number: MR41926 Start Date*: 2021-03-11
    Sponsor Name:F.Hoffman-La Roche Ltd.
    Full Title: AN EXPLORATORY, PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SINGLE-ARM, INTERVENTIONAL, PHASE IIB STUDY TO INVESTIGATE AQUEOUS HUMOR AND MULTIMODAL IMAGING BIOMARKERS IN TREATMENT-NAÏVE PATIENTS WITH DI...
    Medical condition: Diabetic Macular Edema, a complication of Diabetic Retinopathy
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10057934 Diabetic macular edema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) IT (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2013-003450-24 Sponsor Protocol Number: HGT-SAN-093 Start Date*: 2014-04-09
    Sponsor Name:Shire Human Genetic Therapies, Inc
    Full Title: A Randomized, Controlled, Open-label, Multicenter, Phase IIb Safety and Efficacy Study of HGT-1410 (Recombinant Human Heparan N Sulfatase) Administration via an Intrathecal Drug Delivery Device in ...
    Medical condition: Sanfilippo Syndrome Type A or Mucopolysaccharidosis (MPS IIIA)
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10056918 Sanfilippo's syndrome LLT
    17.1 10010331 - Congenital, familial and genetic disorders 10056890 Mucopolysaccharidosis III PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) ES (Completed) NL (Completed) IT (Completed) FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-003515-10 Sponsor Protocol Number: BP41783 Start Date*: 2021-03-09
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A LONGITUDINAL, BIOMARKER STUDY OF ANTI-VEGF, TO EXPLORE THE RELATIONSHIP BETWEEN AQUEOUS HUMOR COMPOSITION AND MULTIMODAL RETINAL IMAGING IN NEOVASCULAR AGE-RELATED MACULAR DEGENERATION AND DIABET...
    Medical condition: Treatment Naïve Neovascular Age-Related Macular Degeneration (nAMD) and Treatment Naïve diabetic macular edema (DME)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10015919 - Eye disorders 10015919 Eye disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) PL (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-020763-20 Sponsor Protocol Number: 10072DMcA-CS Start Date*: 2010-10-04
    Sponsor Name:National University of Ireland, Galway
    Full Title: Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP 2)
    Medical condition: Acute lung injury
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) 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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