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Clinical trials for Congenital cytomegalovirus infection

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
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    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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    12 result(s) found for: Congenital cytomegalovirus infection. Displaying page 1 of 1.
    EudraCT Number: 2015-002232-41 Sponsor Protocol Number: P140310 Start Date*: 2015-11-10
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title:
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10010420 Congenital CMV infection LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-004692-19 Sponsor Protocol Number: 963 Start Date*: 2007-12-19
    Sponsor Name:Biotest AG
    Full Title: Prevention of congenital cytomegalovirus infection in infants of mothers with primary cytomegalovirus infection during pregnancy. A randomised, open, controlled, multicentre and multinational study...
    Medical condition: Congenital CMV infection after primary CMV infection during pregnancy
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10010420 Congenital CMV infection LLT
    Population Age: In utero, Newborns, Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) HU (Completed) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-005525-29 Sponsor Protocol Number: P070115 Start Date*: 2009-07-31
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Traitement in utero de l’infection congénitale à cytomegalovirus (CMV) par valaciclovir : essai prospectif randomisé contre placebo
    Medical condition: L'infection par cytomégalovirus chez la femme enceinte.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10011828 L'Infection à Cytomégalovirus PT
    Population Age: Adults Gender: Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-003068-30 Sponsor Protocol Number: CMV-MM-2 Start Date*: 2013-09-30
    Sponsor Name:LUMC
    Full Title: CONgenital Cytomegalovirus: Efficacy of antiviral treatment in a non-Randomized Trial with historical control group
    Medical condition: Congenital cytomegalovirus infection. Sensorineural Hearingloss.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004850 10010420 Congenital CMV infection LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2020-002383-32 Sponsor Protocol Number: 997 Start Date*: 2021-07-02
    Sponsor Name:Biotest AG
    Full Title: Prevention of maternal-fetal Cytomegalovirus transmission after primary maternal infection with gestational age ≤ 14 weeks – an open-label, single-arm, prospective trial investigating efficacy and ...
    Medical condition: Prevention of maternal-fetal cytomegalovirus transmission after primary maternal infection with gestational age ≤ 14 weeks
    Disease: Version SOC Term Classification Code Term Level
    21.0 10010331 - Congenital, familial and genetic disorders 10010430 Congenital cytomegalovirus infection PT
    20.0 100000004865 10036654 Prevention LLT
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-005508-14 Sponsor Protocol Number: 08/0171 Start Date*: 2010-02-09
    Sponsor Name:University College london
    Full Title: A phase 3 randomized, placebo-controlled blinded investigation of six weeks vs. six months of oral valgancoclovir therapy in infants with symtomatic congenital cytomegalovirus infection. DMID # 06-...
    Medical condition: Symptomatic Congenital Cytomegalovirus.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10010430 Congenital cytomegalovirus infection PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-005378-44 Sponsor Protocol Number: CMV-MM-1 Start Date*: 2012-05-03
    Sponsor Name:LUMC
    Full Title: CONgenital Cmv: Efficacy of antiviral treatment in a Randomized controlled Trial
    Medical condition: Congenital cytomegalovirus infection. Sensorineural Hearingloss.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10010420 Congenital CMV infection LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-002047-15 Sponsor Protocol Number: CCSJ148X2202 Start Date*: 2018-08-01
    Sponsor Name:Novartis Pharma AG
    Full Title: A multicenter, randomized, patient, investigator and sponsor blinded, placebo-controlled phase II study to evaluate the efficacy and safety of CSJ148 in pregnant women with primary HCMV infection
    Medical condition: Congenital human cytomegalovirus (HCMV) infection in pregnant women
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10010420 Congenital CMV infection LLT
    Population Age: In utero, Newborns, Infants and toddlers, Under 18, Adults Gender: Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-006560-11 Sponsor Protocol Number: FARM7J4HCH Start Date*: 2009-02-24
    Sponsor Name:OSPEDALE POLICLINICO S. MATTEO
    Full Title: Prevention of human cytomegalovirus (HCMV) mother-to-fetus transmission by administration of virus-specific hyperimmune globulin to pregnant women with primary HCMV infection
    Medical condition: Pregnant women with primary HCMV infection.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-002924-35 Sponsor Protocol Number: APHP180592 Start Date*: 2021-01-18
    Sponsor Name:ASSISTANCE PUBLIQUE HÔPITAUX DE PARIS
    Full Title: Prenatal treatment of congenital cytomegalovirus infection with letermovir randomized against valaciclovir
    Medical condition: Step 1: Maternal administration of 1 tablet of Letermovir (240 mg or 480 mg /day) during 3 days before TOP Step 2: Maternal daily administration of 240 or 480 milligrams of letermovir (1x240 mg-ta...
    Disease:
    Population Age: Children, Under 18, Adults Gender: Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-004734-37 Sponsor Protocol Number: NORM-01 Start Date*: 2021-12-14
    Sponsor Name:Octapharma Pharmazeutika Prod.Ges.m.b.H
    Full Title: Prospective, open-label, single-arm, multicentre Phase 3 study to evaluate the pharmacokinetics, efficacy, tolerability, and safety of subcutaneous human immunoglobulin (Newnorm) in patients with p...
    Medical condition: Primary Immunodeficiency Diseases
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10064859 Primary immunodeficiency syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) SK (Trial now transitioned) PL (Trial now transitioned) HU (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-001920-31 Sponsor Protocol Number: DMID11-0069 Start Date*: 2014-12-09
    Sponsor Name:University College London
    Full Title: A PHASE II RANDOMIZED AND CONTROLLED INVESTIGATION OF SIX WEEKS OF ORAL VALGANCICLOVIR THERAPY IN INFANTS AND CHILDREN WITH CONGENITAL CYTOMEGALOVIRUS INFECTION AND HEARING LOSS.
    Medical condition: Children born with congenital CMV infection may develop sequelae on follow-up, particularly sensorineural hearing loss. A recent systematic review reports that 13.5% of babies with congenital CMV ...
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004854 10040016 Sensorineural hearing loss LLT
    17.1 100000004854 10040017 Sensorineural hearing loss of combined types LLT
    17.1 100000004854 10040018 Sensorineural hearing loss, unspecified LLT
    17.1 100000004854 10040015 Sensorineural deafness LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: 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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