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Clinical trials for Residence time distribution

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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    54 result(s) found for: Residence time distribution. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2008-000654-12 Sponsor Protocol Number: CE1145_1001 Start Date*: 2008-09-01
    Sponsor Name:Fachbereich Medizin der Johann Wolfgang Goethe-Universität Frankfurt/M.
    Full Title: PHARMACOKINETIC BERINERT P STUDY OF SUBCUTANEOUS VERSUS INTRAVENOUS ADMINISTRATION IN SUBJECTS WITH MODERATE HEREDITARY ANGIOEDEMA - THE PASSION STUDY
    Medical condition: Patients with hereditary angioedema (HAE) suffer from recurring and mostly unforeseeable attacks of acute oedema of subcutaneous tisses of various organs. The pathophysiological correlate of this d...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-003995-65 Sponsor Protocol Number: TAKICARD-1 Start Date*: 2015-11-25
    Sponsor Name:Västra Götalandsregionen, Sahlgrenska University Hospital /Queen Silvia children's hospital
    Full Title: Pharmacokinetics of ANP, a diuretic hormone, in neonates undergoing surgery for congenital heart defects. A pilot study.
    Medical condition: Acute renal failure after heart surgery
    Disease: Version SOC Term Classification Code Term Level
    18.0 10038359 - Renal and urinary disorders 10038447 Renal failure neonatal PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-003932-26 Sponsor Protocol Number: Ga-68-CCK2R Start Date*: 2021-01-20
    Sponsor Name:Medizinische Universität Innsbruck
    Full Title: Phase I/IIa study to evaluate the safety, tolerability, whole-body distribution, and preliminary diagnostic performance of a novel 68Ga-labelled minigastrin analogue in patients with advanced neuro...
    Medical condition: Advanced neuroendocrine tumours (NET), including medullary thyroid carcinoma (MTC), as well as gastroenteropancreatic and bronchopulmonary NET
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-004343-23 Sponsor Protocol Number: IG0902 Start Date*: 2018-03-20
    Sponsor Name:INSTITUTO GRIFOLS, S.A.
    Full Title: Studio per indagare le proprietà farmacocinetiche (per vedere quanto è attivo il farmaco di studio nel sangue e quanto tempo ci vuole per il farmaco di studio per uscire dal sangue), l'efficacia e ...
    Medical condition: Congenital Afibrinogenemia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10052651 Afibrinogenaemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-004154-25 Sponsor Protocol Number: 984 Start Date*: 2013-06-25
    Sponsor Name:Biotest AG
    Full Title: A prospective, open-label, phase I/II study investigating pharmacokinetic properties of BT524 and efficacy and safety of BT524 in the treatment and prophylaxis of bleeding in patients with congenit...
    Medical condition: Patients with congenital afibrinogenemia or severe congenital hypofibrinogenemia.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10016075 Factor I deficiency PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) DE (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2010-024541-67 Sponsor Protocol Number: 1 Start Date*: 2011-11-10
    Sponsor Name:NHS Greater Glasgow & Clyde R&D Office [...]
    1. NHS Greater Glasgow & Clyde R&D Office
    2. The University of Glasgow
    Full Title: Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis – pilot phase
    Medical condition: Acute Ischaemic Stroke
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029205 - Nervous system disorders 10061256 Ischaemic stroke PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-023003-96 Sponsor Protocol Number: BAY86-4875/91741 Start Date*: 2012-04-25
    Sponsor Name:Bayer HealthCare AG
    Full Title: Open-label, multicenter, pharmacokinetic, and safety study in children (term newborn infants to 23 months of age) undergoing a contrast-enhanced MRI with an intravenous injection of 0.1 mmol/kg BW ...
    Medical condition: Pediatric subjects aged <2 years (term newborn infants to toddlers 23 months of age inclusive) scheduled to undergo routine gadolinium-enhanced MRI of any body region
    Disease:
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-004451-70 Sponsor Protocol Number: NOR-GRASPALL-2016 Start Date*: 2017-04-06
    Sponsor Name:Department of pediatrics, Aarhus University Hospital
    Full Title: NOR-GRASPALL 2016: SINGLE-ARM PHARMACOKINETIC/PHARMACODYNAMIC AND SAFETY STUDY OF ERYASPASE (GRASPA®) FOR PATIENTS WITH HYPERSENSITIVITY TO PEG-ASPARAGINASE, DIAGNOSED WITH PH(-) ACUTE LYMPHOBLASTI...
    Medical condition: Patients with acute lymphoblastic leukemia with allergy against PEG-asparaginase
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DK (Completed) NO (Completed) FI (Completed) SE (Completed) EE (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2013-004544-32 Sponsor Protocol Number: CT-P27/2.1 Start Date*: 2014-02-10
    Sponsor Name:Celltrion, Inc
    Full Title: Randomized, double-blind, placebo-controlled, single-centre, phase IIa study in healthy volunteers to evaluate the efficacy and safety of CT-P27 in an influenza challenge model
    Medical condition: Influenza
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-004727-37 Sponsor Protocol Number: CAAA603A12101 Start Date*: 2019-02-18
    Sponsor Name:Advanced Accelerator Applications International SA
    Full Title: A Phase I/IIa open-label, multi-center study to evaluate the safety, tolerability, whole-body distribution, radiation dosimetry and anti-tumor activity of [177Lu]-NeoB administered in patients with...
    Medical condition: Solid tumors known to overexpress GRPR and with [68Ga]-NeoB lesion uptake
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned) GB (GB - no longer in EU/EEA) NL (Trial now transitioned) DE (Completed) ES (Ongoing) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-001900-13 Sponsor Protocol Number: D4280C00014 Start Date*: 2013-06-05
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase I Study to Assess the Pharmacokinetics, Safety and Tolerability of a Single Dose of Ceftazidime-Avibactam (CAZ-AVI) in Children From 3 Months of Age to <18 Years Who Are Receiving Systemic ...
    Medical condition: hospitalized pediatric patients receiving systemic antibiotic therapy for suspected or confirmed infection.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10021804 Infection bacterial LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-004307-40 Sponsor Protocol Number: ATN-106 Start Date*: 2022-01-31
    Sponsor Name:Octapharma AG
    Full Title: A multicentre, prospective, open-label, uncontrolled Phase 3 study to assess the efficacy, safety and pharmacokinetics of Atenativ in patients with congenital antithrombin deficiency undergoing sur...
    Medical condition: Congenital antithrombin deficiency
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004850 10083881 Antithrombin deficiency LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) AT (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned) DE (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-002023-15 Sponsor Protocol Number: EFC16293 Start Date*: 2020-02-25
    Sponsor Name:Bioverativ Therapeutics Inc. (a Sanofi company)
    Full Title: Phase 3 Open-Label, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein (rFVIIIFc-VWF-XTE...
    Medical condition: severe hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10016080 Factor VIII deficiency PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) FR (Completed) BG (Completed) BE (Completed) GR (Completed) HU (Completed) NL (Completed) ES (Completed) Outside EU/EEA IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-003935-32 Sponsor Protocol Number: D3820C00016 Start Date*: 2014-03-07
    Sponsor Name:Kyowa Kirin Pharmaceutical Development Ltd.
    Full Title: A Phase I, Open-Label, Multicentre Study to Assess the Pharmacokinetics and Safety of Naloxegol in Paediatric Patients Ages ≥ 6 Months to < 18 Years Receiving Treatment with Opioids
    Medical condition: Opioid-induced constipation
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10071128 Opioid induced constipation LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) ES (Prematurely Ended) NO (Prematurely Ended) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-005477-37 Sponsor Protocol Number: 261303 Start Date*: 2016-01-26
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: Phase 3, prospective, randomized, multi-center clinical study comparing the safety and efficacy of BAX 855 following PK-guided prophylaxis targeting two different FVIII trough levels in subjects wi...
    Medical condition: Severe hemophilia A (FVIII <1%)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000011915 10060612 Hemophilia A LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) AT (Completed) SE (Completed) CZ (Prematurely Ended) ES (Completed) HU (Completed) BG (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-002854-22 Sponsor Protocol Number: UGA2014-01 Start Date*: 2020-01-03
    Sponsor Name:Aryogen Pharmed
    Full Title: A RANDOMIZED, MULTICENTER, DOUBLE BLIND CLINICAL TRIAL COMPARING PHARMACODYNAMIC, PHARMACOKINETIC AND SAFETY OF A BIOSIMILAR EPTACOG ALFA (ARYOSEVEN) AND NOVOSEVEN®, IN PATIENTS WITH HAEMOPHILIA A ...
    Medical condition: HAEMOPHILIA A OR B WITH INHIBITORS
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053752 Hemophilia B with anti factor IX LLT
    20.0 100000004850 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Adults Gender: Male
    Trial protocol: BG (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2004-001716-31 Sponsor Protocol Number: 20040124 Start Date*: 2015-09-17
    Sponsor Name:Swedish Orphan Biovitrum AB (publ.)
    Full Title: A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Weekly Doses of Palifermin (Recombinant Human Keratinocyte Growth Factor, rHuKGF) for the Reduct...
    Medical condition: Oral Mucositis
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004856 10028130 Mucositis oral LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-001477-33 Sponsor Protocol Number: 071102 Start Date*: 2016-12-01
    Sponsor Name:Baxalta Innovations GmbH
    Full Title: A Phase 3, Prospective, Multicenter, Uncontrolled, Open-Label Clinical Study to Determine the Efficacy, Safety, and Tolerability of rVWF with or without ADVATE in the Treatment and Control of Bleed...
    Medical condition: Hereditary severe von Willebrand Disease in children
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10055168 Von Willebrand's factor deficiency LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: AT (Trial now transitioned) IT (Trial now transitioned) GB (GB - no longer in EU/EEA) BE (Trial now transitioned) CZ (Completed) ES (Trial now transitioned) FR (Trial now transitioned) DE (Completed) NL (Completed) Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2011-005679-18 Sponsor Protocol Number: GMX04 Start Date*: 2011-12-07
    Sponsor Name:Bio Products Laboratory Limited
    Full Title: A Phase IV, Multicenter, Open-Label Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases (PID) in Children and Adolescents
    Medical condition: Primary immunodeficiency diseases
    Disease: Version SOC Term Classification Code Term Level
    14.0 10005329 - Blood and lymphatic system disorders 10005329 Blood and lymphatic system disorders SOC
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: Removed from public view
    EudraCT Number: 2011-002774-23 Sponsor Protocol Number: 248.600 Start Date*: 2011-11-04
    Sponsor Name:Boehringer Ingelheim Pharmaceuticals, Inc.
    Full Title: An open-label clinical study to investigate pharmacokinetics (PK) of different doses (0.125 mg, 0.25 mg, 0.5 mg) of pramipexole administered once daily orally in pediatric patients who are individu...
    Medical condition: Restless Legs Syndrome
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029205 - Nervous system disorders 10058920 Restless legs syndrome PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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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