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Clinical trials for Enzyme regulation

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    19 result(s) found for: Enzyme regulation. Displaying page 1 of 1.
    EudraCT Number: 2008-005861-80 Sponsor Protocol Number: Start Date*: 2010-01-21
    Sponsor Name:SCIOTEC DIAGNOSTIC TECHNOLOGIES GMBH
    Full Title: Efficacy of Fructose metabolizing enzymatic product Fructosin(R) with Fructose malabsorption ( Wirkamkeit des Fruktose-abbauenden Enzympräparates Fructosin® bei Fruktose-Malabsorption)
    Medical condition: Fructose Intolerance; Incapability to digest fructose contained in food
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-000942-77 Sponsor Protocol Number: EFC14028 Start Date*: 2016-07-15
    Sponsor Name:Genzyme Corporation
    Full Title: A Phase 3 Randomized, Multicenter, Multinational, Double-blinded Study Comparing the Efficacy and Safety of Repeated Biweekly Infusions of Avalglucosidase Alfa (neoGAA, GZ402666) and Alglucosidase ...
    Medical condition: Pompe disease (acid alpha-glucosidase deficiency)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10036143 Pompe's disease LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DK (Prematurely Ended) SE (Prematurely Ended) NL (Completed) ES (Completed) CZ (Completed) DE (Completed) BE (Completed) AT (Completed) PL (Completed) IT (Completed) PT (Completed) BG (Completed) HU (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-003404-39 Sponsor Protocol Number: JBR-2-2013 Start Date*: 2014-01-03
    Sponsor Name:Department of Medical Research, Regional Hospital Holstebro
    Full Title: The effect of sodium nitrite infusion on renal variables, brachial and central blood pressure during enzyme inhibition by allopurinol, enalapril or acetazolamid in healthy subjects. A randomized, d...
    Medical condition: The normal physiological responses in healthy subjects
    Disease: Version SOC Term Classification Code Term Level
    14.1 10022891 - Investigations 10022891 Investigations SOC
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-023979-25 Sponsor Protocol Number: 2010/353 Start Date*: 2011-01-03
    Sponsor Name:Department of Nephrology
    Full Title: Role of renal and systemic vascular resistance for progression of chronic kidney disease
    Medical condition: We want to investigate whether increased vasodilitation ( angiotensin converting enzyme inhibitor and calcium channel blocker) compared to standard treatment ( beta-blocker and angiotensin convert...
    Disease: Version SOC Term Classification Code Term Level
    13.1 10047065 - Vascular disorders 10063097 Peripheral vasodilatation LLT
    13.1 10047065 - Vascular disorders 10047141 Vasodilatation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-002760-41 Sponsor Protocol Number: CL2-RTCCAR-001 Start Date*: 2017-09-18
    Sponsor Name:institute de Recherches Internacionales Servier (promotor internacional)
    Full Title: Assessment of Active Thrombin-Activatable Fibrinolysis Inhibitor (TAFIa) plasma kinetics in Patients at acute stage of Ischemic Stroke: Prospective, Multicentre, Open, Non-randomised, Biomarker Study
    Medical condition: Acute Ischemic Stroke
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000013700 10055221 Ischemic stroke LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2016-003475-21 Sponsor Protocol Number: ACT14132 Start Date*: 2017-05-17
    Sponsor Name:Genzyme Corporation
    Full Title: An Open-label Ascending Dose Cohort Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of Avalglucosidase Alfa (NeoGAA, GZ402666) in Patients with Infantile-onset Pompe Disease ...
    Medical condition: Pompe disease (acid alpha-glucosidase deficiency)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10036143 Pompe's disease LLT
    20.1 10010331 - Congenital, familial and genetic disorders 10053185 Glycogen storage disease type II PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) FR (Ongoing) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-000064-21 Sponsor Protocol Number: LPS15918 Start Date*: Information not available in EudraCT
    Sponsor Name:Sanofi Aventis Groupe (SAG)
    Full Title: A randomized, open-label, active comparator, 2-arm, prospective study to assess the glycosphingolipid clearance and clinical benefits of agalsidase beta (Fabrazyme®) in male patients with classic F...
    Medical condition: Fabry's disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: NO (Prematurely Ended) CZ (Prematurely Ended) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2024-000461-24 Sponsor Protocol Number: LPS15677 Start Date*: 2024-12-18
    Sponsor Name:Genzyme
    Full Title: A Single Arm, Prospective, Open-label, Multi-center Study to Evaluate Efficacy and Safety in Chinese Patients with Late Onset Pompe Disease with One Year Alglucosidase Alfa Treatment
    Medical condition: Pompe's disease
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-020860-39 Sponsor Protocol Number: A5271037 Start Date*: 2010-12-20
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: A LONG-TERM OPEN-LABEL EXTENSION STUDY OF LERSIVIRINE FOR THE TREATMENT OF HIV-1 INFECTION
    Medical condition: Treatment of HIV-1 infection in combination with other agents in antiretroviral treatment naive and antiretroviral treatment-experienced subjects.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10068341 HIV-1 infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) IT (Prematurely Ended) PT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-000065-20 Sponsor Protocol Number: LPS15919 Start Date*: 2020-02-05
    Sponsor Name:Sanofi Aventis Groupe (SAG)
    Full Title: A randomized, open-label, active comparator, 2-arm, prospective study to assess the glycosphingolipid clearance and clinical effects of switching to agalsidase beta (Fabrazyme®) versus continuing o...
    Medical condition: Fabry disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10016016 Fabry's disease PT
    Population Age: Adolescents, Under 18, Adults Gender: Male
    Trial protocol: NO (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-003859-36 Sponsor Protocol Number: VAC18194RSV2002 Start Date*: 2019-03-27
    Sponsor Name:Janssen Vaccines and Prevention B.V.
    Full Title: A Randomized, Controlled, Observer-blind, Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.RSV.preF in RSV-seronegative Toddlers 12 to 24 Months of Age
    Medical condition: Prophylactic respiratory syncytial virus (RSV)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) DE (Prematurely Ended) GB (GB - no longer in EU/EEA) FI (Completed) ES (Completed) Outside EU/EEA PL (Completed)
    Trial results: View results
    EudraCT Number: 2006-002183-26 Sponsor Protocol Number: TMC125-C126 Start Date*: Information not available in EudraCT
    Sponsor Name:Tibotec Pharmaceuticals Ltd
    Full Title: A Phase I, open-label trial to investigate pharmacokinetics, safety and tolerability of TMC125 at steady-state in treatment-experienced HIV-1 infected children.
    Medical condition: HIV-1
    Disease: Version SOC Term Classification Code Term Level
    8.1 10020192 HIV-1 LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-007086-21 Sponsor Protocol Number: TMC125-TiDP35-C213 Start Date*: 2009-01-23
    Sponsor Name:Tibotec Pharmaceuticals
    Full Title: A Phase II, open-label trial to evaluate the safety, tolerability and antiviral activity of TMC125 in antiretroviral experienced HIV-1 infected children and adolescents.
    Medical condition: HIV-1 infection
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020192 HIV-1 LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) BE (Completed) PT (Completed) ES (Completed) FR (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-016654-41 Sponsor Protocol Number: PTC124-GD-012-MMA Start Date*: 2010-03-02
    Sponsor Name:PTC Therapeutics, Inc.
    Full Title: A Phase 2 Study of Ataluren (PTC124) as an Oral Treatment for Nonsense Mutation Methylmalonic Acidemia
    Medical condition: Nonsense Mutation Methylmalonic Acidemia
    Disease: Version SOC Term Classification Code Term Level
    12.1 10064180 Blood methylmalonic acid increased LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed) GB (Prematurely Ended) IT (Prematurely Ended) BE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-003487-48 Sponsor Protocol Number: F373280CA201 Start Date*: 2013-02-25
    Sponsor Name:PIERRE FABRE MEDICAMENT
    Full Title: Efficacy and safety study of F373280 for maintenance of sinus rhythm after electrical cardioversion in patients with persistent Atrial Fibrillation and Chronic Heart Failure.
    Medical condition: F373280 is a new therapy based on DHA delivery (pro-drug) developed for the maintenance of sinus rhythm after electrical cardioversion in persistent atrial fibrillation (AF) patients with chronic h...
    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: ES (Completed) HU (Completed) CZ (Completed) IT (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2014-002596-28 Sponsor Protocol Number: PTC124-GD-024-MPS Start Date*: 2015-06-01
    Sponsor Name:PTC Therapeutics Inc.
    Full Title: CNS Unmet Medical Need in Mucopolysaccharidosis: A Phase 2 Safety and Pharmacokinetics Study of Ataluren (COMPASS)
    Medical condition: Nonsense mutation Mucopolysaccharidosis Type I
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10056886 Mucopolysaccharidosis I PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-003105-41 Sponsor Protocol Number: PTC124-GD-031-MPS Start Date*: 2015-10-13
    Sponsor Name:PTC Therapeutics Inc.
    Full Title: CNS Unmet Medical Need in Mucopolysaccharidosis: A Phase 2 Safety and Pharmacokinetics Study of Ataluren (COMPASS)
    Medical condition: Nonsense mutation Mucopolysaccharidosis Type I
    Disease: Version SOC Term Classification Code Term Level
    18.1 10010331 - Congenital, familial and genetic disorders 10056886 Mucopolysaccharidosis I PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-003208-42 Sponsor Protocol Number: CA209-6GE Start Date*: 2022-06-15
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3, Open Label, Randomized, Non-Inferiority Pharmacokinetic Study of Nivolumab Administered Subcutaneously (Nivo SC) Versus Intravenous Administration of Nivolumab in Participants with Stage...
    Medical condition: Resected Stage IIIA/B/C/D or Stage IV melanoma in an adjuvant setting
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025671 Malignant melanoma stage IV PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025670 Malignant melanoma stage III PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Temporarily Halted) BE (Completed) PL (Completed) DE (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-009995-11 Sponsor Protocol Number: CNIM811B2202 Start Date*: 2009-07-20
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, adaptive-design dose finding study to assess the antiviral efficacy and safety of NIM811 administered in combination with Standard of Care (SOC) for 12 weeks in relapsed HCV-1 infecte...
    Medical condition: Hepatitis C genotype 1 relapser
    Disease: Version SOC Term Classification Code Term Level
    9.1 10019744 Hepatitis C LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) IT (Completed) BE (Completed) NL (Prematurely Ended)
    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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