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Clinical trials for Congenital Malformation

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    20 result(s) found for: Congenital Malformation. Displaying page 1 of 1.
    EudraCT Number: 2016-002157-38 Sponsor Protocol Number: 57911 Start Date*: 2017-09-14
    Sponsor Name:Radboud University Medical Center
    Full Title: Treatment of congenital vascular malformations using Sirolimus: improving quality of Life
    Medical condition: congenital vascular malformation : Vascular malformations can involve lymphatic vessels, capillaries, veins and arteries or even combinations. These vascular malformations are present at birth an...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000005125 10047091 Vascular malformations and acquired anomalies HLT
    20.0 100000158692 10047090 Vascular malformation peripheral LLT
    20.0 10017947 - Gastrointestinal disorders 10070181 Gastrointestinal vascular malformation PT
    20.0 10010331 - Congenital, familial and genetic disorders 10074979 Vascular malformation PT
    Population Age: Infants and toddlers, Children, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2011-001455-37 Sponsor Protocol Number: 1331TMF Start Date*: 2011-12-21
    Sponsor Name:Department of Radiology, Oslo University Hospital, Norway
    Full Title: Prospective randomized interventional study. Compare the effect of bleomycin and Tetradecyl Sodium Sulphate (Fibrovein) in the treatment of venous malformations. Clinical neurological and neurophys...
    Medical condition: Venous malformation
    Disease: Version SOC Term Classification Code Term Level
    13.1 10010331 - Congenital, familial and genetic disorders 10047229 Venous malformation NOS LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-001096-43 Sponsor Protocol Number: PHRN14-AM/PERFORMUS Start Date*: 2015-07-10
    Sponsor Name:CHRU de Tours
    Full Title: Treatment of superficial voluminous complicated slow-flow vascular malformations with sirolimus: a phase 2 trial in children observational-phase designed
    Medical condition: vascular malformations
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10074979 Vascular malformation PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-003595-30 Sponsor Protocol Number: IRFMN-7358 Start Date*: 2018-02-21
    Sponsor Name:IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
    Full Title: Treat_CCM Clinical Trial. A multicenter randomized clinical trial on Propranolol in Cerebral Cavernous Malformation
    Medical condition: Cerebral Cavernous Malformation (CCM)
    Disease: Version SOC Term Classification Code Term Level
    23.0 10010331 - Congenital, familial and genetic disorders 10071747 Cerebral cavernous malformation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-019713-21 Sponsor Protocol Number: CS/2007/2678 Start Date*: 2010-06-17
    Sponsor Name:University Hospitals Bristol NHS Foundation Trust
    Full Title: A RANDOMISED CONTROLLED TRIAL TO COMPARE NORMOXIC VERSUS STANDARD CARDIOPULMONARY BYPASS IN CYANOTIC CHILDREN UNDERGOING CARDIAC SURGERY
    Medical condition: The study investigates reoxygenation injury in cyanotic paediatric patients undergoing on-pump cardiac surgery. The types of heart condition being investigated result in chronic low blood oxygen sa...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10010395 Congenital cardiac malpositions and transpositions HLT
    12.1 10010397 Congenital cardiac structural defects NEC HLT
    12.1 10010396 Congenital cardiac septal defect NOS LLT
    12.1 10062326 Congenital cardiac septal defect LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2019-004981-16 Sponsor Protocol Number: 1991-201-008 Start Date*: 2022-06-17
    Sponsor Name:Editas Medicine, Inc.
    Full Title: Open-Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Efficacy of EDIT-101 in Adult and Pediatric Participants with Leber Congenital Amaurosis Type 10 (LCA10), with Cen...
    Medical condition: Leber Congenital Amaurosis Type 10 (LCA10), with Centrosomal Protein 290 (CEP290)-Related Retinal Degeneration Caused by a Compound Heterozygous or Homozygous Mutation Involving c.2991+1655A>G in I...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10015920 Eye disorders congenital HLGT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-001530-33 Sponsor Protocol Number: DR190041 Start Date*: 2019-06-29
    Sponsor Name:CHRU TOURS
    Full Title: TOPical sirolimus in linGUal microkystic lymphatic malformation-TOPGUN
    Medical condition: Lingual microcystic lymphatic malformations (LMLM) in children and adults
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10003229 Arteriovenous malformations LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-004322-28 Sponsor Protocol Number: P120910 Start Date*: Information not available in EudraCT
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title:
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10062326 Congenital cardiac septal defect LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-003325-10 Sponsor Protocol Number: 1.01 Start Date*: 2012-08-10
    Sponsor Name:VU University Medical Center
    Full Title: A randomized controlled trail on the effects of periconceptional and prenatal folic acid supplementation on congenital anomalies and preterm birth
    Medical condition: congenital anomalies
    Disease: Version SOC Term Classification Code Term Level
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10004953 Birth premature LLT
    14.1 10010331 - Congenital, familial and genetic disorders 10007607 Cardiac septal defects congenital HLT
    14.1 10010331 - Congenital, familial and genetic disorders 10041524 Spina bifida PT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-001703-32 Sponsor Protocol Number: VASE Start Date*: 2015-11-09
    Sponsor Name:Cliniques Universitaires Saint-Luc (CUSL)
    Full Title: Phase III multicentric study evaluating the efficacy and safety of sirolimus in Vascular Anomalies that are refractory to standard care
    Medical condition: Complex vascular anomalies causing debilitating functional and esthetic impairment that are resistant to standard care
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004850 10047047 Vascular anomalies congenital NEC HLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Ongoing) FR (Completed) DE (Ongoing) NO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003181-12 Sponsor Protocol Number: HOTPOT1 Start Date*: 2016-10-07
    Sponsor Name:Royal College of Surgeons in Ireland
    Full Title: Can sonographic assessment of pulmonary vascular reactivity following maternal hyperoxygenation therapy predict neonatal outcome in fetuses at risk of pulmonary hypertension?
    Medical condition: Persistent pulmonary hypertension of the newborn (PPHN) is a relatively common condition occurring in 7/1000 births and can result in significant cardiovascular instability in the newborn. It occur...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2022-003287-25 Sponsor Protocol Number: 2018-002863-24,2022-003287-25 Start Date*: 2023-04-10
    Sponsor Name:Erasmus University Medical Center - Sophia Childrens Hospital
    Full Title: Intralesional steroid injections to prevent refractory strictures in patients with esophageal atresia - a randomized controlled trial
    Medical condition: Recurrent anastomotic strictures in the esophagus following surgical repair with primary anastomosis of esophageal atresia in neonates.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-004952-80 Sponsor Protocol Number: A0661158 Start Date*: 2015-04-03
    Sponsor Name:Pfizer Inc
    Full Title: Phase 3, Open-Label, Randomized, Comparative Study to Evaluate Azithromycin plus Chloroquine and Sulfadoxine plus Pyrimethamine Combinations for Intermittent Preventive Treatment of Falciparum Mala...
    Medical condition: Intermittent Preventive Treatment In Pregnancy (IPTp)
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10025487 Malaria PT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-002286-17 Sponsor Protocol Number: INCB00928-201 Start Date*: 2022-04-19
    Sponsor Name:Incyte Corporation
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
    Medical condition: Fibrodysplasia ossificans progressiva
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Not Authorised) DE (Ongoing) NL (Ongoing) PT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-000880-40 Sponsor Protocol Number: R2477-FOP-2175 Start Date*: 2022-08-29
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: Phase 3 Randomized, Placebo-Controlled Study to Assess Safety, Tolerability, and Efficacy of Garetosmab in Patients with Fibrodysplasia Ossificans Progressiva
    Medical condition: Fibrodysplasia Ossificans Progressiva
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) FI (Trial now transitioned) IT (Ongoing) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-002516-85 Sponsor Protocol Number: 01-2011 Start Date*: 2011-10-20
    Sponsor Name:A.O. UNIVERSITARIA INTEGRATA DI VERONA
    Full Title: Open-label study to evaluate the efficacy and tolerability of orally administered rosiglitazone in patients with progressive bone Fibrodysplasia (FOP)
    Medical condition: Fibrodysplasia Ossificans Progressive (FOP) is a rare genetically based disability, characterized by progressive heterotopic ossification, usually associated with congenital malformation of the toes.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10028393 Musculoskeletal and connective tissue disorders NEC HLGT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-005035-33 Sponsor Protocol Number: R2477-FOP-1623 Start Date*: 2017-08-15
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and effects on heterotopic bone formation of REGN2477 in patients with Fibrodysplasia Ossificans Progres...
    Medical condition: Fibrodysplasia Ossificans Progressiva (FOP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) NL (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2019-003324-20 Sponsor Protocol Number: STOPFOP1 Start Date*: 2020-01-08
    Sponsor Name:VU University Medical Center
    Full Title: Saracatinib trial TO Prevent FOP
    Medical condition: Fibrodyplasia Ossificans Progressiva (FOP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003248-34 Sponsor Protocol Number: IMPAACTP1110 Start Date*: 2016-11-02
    Sponsor Name:NIAID and NICHD
    Full Title: A PHASE I TRIAL TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF RALTEGRAVIR IN HIV-1-EXPOSED NEONATES AT HIGH RISK OF ACQUIRING HIV-1 INFECTION
    Medical condition: New born babies at risk of acquiring HIV from their infected mothers.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10053529 Vertical human immunodeficiency virus transmission LLT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-020209-33 Sponsor Protocol Number: 07052010 Start Date*: 2010-10-12
    Sponsor Name:University Hospitals Leuven
    Full Title: BOsentan for Mild Pulmonary vascular disease in Asd patients (the BOMPA trial): a double-blind, randomized controlled, pilot trial
    Medical condition: Repaired (after the age of 40) atrial septal defect patients older than 40 years with evidence of mild pulmonary vascular disese as assessed by bicycle stress echocardiography.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10003664 Atrial septal defect LLT
    12.1 10037400 Pulmonary hypertension LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (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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