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Clinical trials for Single ventricle

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   44334   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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    36 result(s) found for: Single ventricle. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2011-001187-21 Sponsor Protocol Number: SCRM-001 Start Date*: 2011-11-28
    Sponsor Name:University of Zurich
    Full Title: A Phase I/II, Open Monocentric Study To Evaluate The Safety And Efficacy Of An Autologous Tissue-Engineered Vascular Graft In Peadiatric Patients Requiring Reconstruction Of Right Ventricle Outflow...
    Medical condition: functional single ventricle physiology functional single left ventricle functional single right ventricle functional single biventricle
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10040729 Single ventricle LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-002688-28 Sponsor Protocol Number: 66/2007/U/Sper Start Date*: 2007-05-22
    Sponsor Name:AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
    Full Title: Pilot study on the short-term effects of Sildenafil on hemodynamic response to exercise and exercise capacity in Fontan patients
    Medical condition: congenital heart disease
    Disease: Version SOC Term Classification Code Term Level
    6.1 10045545 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-002610-76 Sponsor Protocol Number: 39039039CHD3001/BAY59-7939-18226 Start Date*: 2016-09-21
    Sponsor Name:Janssen-Cilag International N.V
    Full Title: A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years ...
    Medical condition: thromboprophylaxis
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004850 10040729 Single ventricle LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) ES (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2005-005898-29 Sponsor Protocol Number: RRK2962 Start Date*: 2008-07-04
    Sponsor Name:University Hospital Birmingham
    Full Title: The effect of bosentan, a selective endothelin antagonist, on cardiovascular performance in patients with a Fontan circulation
    Medical condition: Patients with a Fontan circulation (that is they have had a Fontan operation for a functionally univentricular heart)
    Disease: Version SOC Term Classification Code Term Level
    9.1 10045545 Univentricular heart LLT
    9.1 10065950 Cavopulmonary anastomosis LLT
    9.1 10037456 Pulmonary vascular resistance abnormality LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-002821-45 Sponsor Protocol Number: AC-055H302 Start Date*: 2019-03-05
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects
    Medical condition: Congenital Heart Failure
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10045545 Univentricular heart PT
    20.0 10042613 - Surgical and medical procedures 10065950 Cavopulmonary anastomosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed) DE (Completed) GB (GB - no longer in EU/EEA) DK (Completed) PL (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2013-001659-10 Sponsor Protocol Number: S55481 Start Date*: 2013-08-08
    Sponsor Name:UZLeuven
    Full Title: Acute effects of Sildenafil on the hemodynamics, Right Ventricle performance and cyclic GMP concentration in Heart failure patients with preserved left ventricular ejection fraction and patients af...
    Medical condition: To investigate acute effects of sildenafil on cardiac hemodynamics, right ventricle performance and cGMP concentrations in heart failure patients with preserved ejection fraction and patients after...
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004855 10037406 Pulmonary hypertension secondary LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2016-003320-23 Sponsor Protocol Number: AC-055H301 Start Date*: 2017-10-11
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: Prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study assessing the efficacy and safety of macitentan in Fontan-palliated adult and adolescent subjects.
    Medical condition: Congenital Heart Failure
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10045545 Univentricular heart PT
    21.1 10042613 - Surgical and medical procedures 10065950 Cavopulmonary anastomosis PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) DK (Completed) FR (Completed) PL (Completed) IE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2014-002257-19 Sponsor Protocol Number: CARDIORYC-2014-001 Start Date*: 2015-04-21
    Sponsor Name:Fundación para la Investigación Biomédica del Hospital Ramón y Cajal
    Full Title: Single-center, randomized, open, controlled by echocardiography to evaluate the effect of serelaxina in the functioning of the right ventricle and its potential in the prognosis of acute heart fail...
    Medical condition: ICA hospitalized patients with high normal blood pressure, and mild to moderate renal failure at the time of selection
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004849 10007648 Cardiovascular disease, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-001112-29 Sponsor Protocol Number: CL-N-HTX-CSM-III/04/12 Start Date*: 2015-07-27
    Sponsor Name:Dr. Franz Köhler Chemie GmbH
    Full Title: A Prospective, randomized, single blind, multicenter Phase III study of organ perfusion with Custodiol-N solution compared with Custodiol solution in Heart transplantation
    Medical condition: Patients that has to undergo (is suitable for) a heart transplantation
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2013-002000-14 Sponsor Protocol Number: CM042013 Start Date*: 2013-07-17
    Sponsor Name:University Hospitals Leuven
    Full Title: The effects of right paravertebral blockade on biventricular performance in patients with chronic pulmonary hypertension scheduled for minimally invasive mirtral valve surgery.
    Medical condition: patients with pulmonary hypertension scheduled for elective minimally invasive mitral valve surgery using heartport technique.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-000134-22 Sponsor Protocol Number: MDCO-CAN-15-01 Start Date*: 2021-01-14
    Sponsor Name:Chiesi Farmaceutici S.p.A.
    Full Title: A Prospective, Open-Label, Single-Arm, Multi-Center Study to Assess The Pharmacokinetics/Pharmacodynamics (PK/PD) AND Safety Of Different Cangrelor Doses In Neonatal Subjects At Risk Of Thrombosis.
    Medical condition: Postoperative neonatal cardiac subjects who are undergoing surgery for placement of systemic-to pulmonary artery palliative shunts (e.g., Blalock-Taussig or central shunt), right ventricle to pulmo...
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-002520-33 Sponsor Protocol Number: SNT-II-1 Start Date*: 2005-09-06
    Sponsor Name:Santhera Pharmaceuticals LLC
    Full Title: A Phase IIa double blind, randomised, placebo controlled, single centre study at the university of Leuven to assess the efficacy and tolerability of idebenone in 10 - 16 year old males with cardiac...
    Medical condition: Duchenne Muscular Dystrophy
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-001205-41 Sponsor Protocol Number: VIPER–AMI Start Date*: 2015-01-09
    Sponsor Name:Sociedade Portuguesa de Cardiologia
    Full Title: VIldagliptin as an ischemic PERconditioning mimetic agent in Acute Myocardial Infarction – A single centre, randomized, parallel-group, double-blind clinical trial, for assessing the effectiveness...
    Medical condition: ST Elevation Myocardial Infarction
    Disease: Version SOC Term Classification Code Term Level
    17.1 10007541 - Cardiac disorders 10000891 Acute myocardial infarction PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-002198-37 Sponsor Protocol Number: ENHVIE Start Date*: 2016-09-19
    Sponsor Name:HOSPITAL UNIVERSITARI DE BELLVITGE - IDIBELL
    Full Title: A single-center, randomized, open-label, 12 months study, with two parallel group to compare the efficacy of everolimus combination + tacrolimus in regression of left ventricular hypertrophy vs tac...
    Medical condition: Left ventricular hypertrophy in renal transplant patients in the maintenance phase .
    Disease: Version SOC Term Classification Code Term Level
    19.0 10007541 - Cardiac disorders 10049773 Left ventricular hypertrophy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-002847-28 Sponsor Protocol Number: CRLX030A2208 Start Date*: 2014-06-26
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Multicenter, open-label, dose escalation study to evaluate safety, tolerability and pharmacokinetics of RLX030 in addition to standard of care in pediatric patients from birth to <18 years of age, ...
    Medical condition: acute heart failure
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004849 10000803 Acute heart failure LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-001109-22 Sponsor Protocol Number: PBGM01-001 Start Date*: Information not available in EudraCT
    Sponsor Name:Passage Bio, Inc.
    Full Title: A Phase 1/2 Open-Label, Multicenter, Dose Ranging and Confirmatory Study to Assess the Safety, Tolerability and Efficacy of a Single Dose of PBGM01 Delivered into the Cisterna Magna of Pediatric Su...
    Medical condition: GM1 gangliosidosis (GM1) is an autosomal recessive disorder that results from mutations in the human galactosidase beta 1 gene (GLB1), which encodes beta-galactosidase (β-gal).
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2019-004427-20 Sponsor Protocol Number: CHHEF Start Date*: 2020-02-07
    Sponsor Name:Luis Puente Maestu
    Full Title: PHASE IV, SINGLE-CENTER, DOUBLE BLIND, RANDOMIZED, CROSSOVER, PLACEBO-CONTROLLED STUDY, TO INVESTIGATE THE EFFECT OF DUAL BRONCHODILATION WITH UMECLIDINIUM VILANTEROL ON PATIENTS WITH COPD, HYPERIN...
    Medical condition: Chronic obstructive pulmonary diseases with Heart Failure with eyection ventricular ejection fraction between 35-50%
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10013108 Disease obstructive lung LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-004677-17 Sponsor Protocol Number: 141022 Start Date*: 2016-02-29
    Sponsor Name:Kvinnokliniken, Universitetssjukhuset i Linköping, Landstinget i Östergötland
    Full Title: Contraception after gastric bypass - part 4 How does gastric bypass affect the pharmacocinetics of oral levonorgestrel?
    Medical condition: We want to investigate if the pharmacocinetics of levonorgestrel differs in women who have had bariatric surgery compared to women who have not. Measures of serum concentrations of levonorgestrel w...
    Disease: Version SOC Term Classification Code Term Level
    18.1 10042613 - Surgical and medical procedures 10030970 Oral contraception PT
    18.1 10042613 - Surgical and medical procedures 10061966 Gastric bypass PT
    Population Age: Adults Gender: Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-001250-91 Sponsor Protocol Number: GV-002.001 Start Date*: 2005-10-04
    Sponsor Name:GenVec, Inc.
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of BIOBYPASS® (ADGVVEGF121.10NH) Delivered by NOGA-Guided/MYOSTAR Catheter in "No Option" Patients with Cla...
    Medical condition: Moderate to severe angina pectoris due to advanced coronary artery disease (CAD).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) AT (Completed) DE (Completed) GB (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-021062-29 Sponsor Protocol Number: CICL670A2214 Start Date*: 2010-12-21
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Phase II, open-label, single-arm, multicenter study to evaluate the efficacy and safety of deferasirox in combination with deferoxamine followed by deferasirox monotherapy in patients with severe c...
    Medical condition: transfusion-dependent patients with TM, DBA or congenital sideroblastic anemia with severe cardiac iron overload
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10065974 Chronic iron overload LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) GR (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
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