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Clinical trials for Letermovir

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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    6 result(s) found for: Letermovir. Displaying page 1 of 1.
    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: 2018-001326-25 Sponsor Protocol Number: MK-8228-030 Start Date*: 2019-05-27
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
    Full Title: A Phase 2b open-label, single-arm study to evaluate pharmacokinetics, efficacy, safety and tolerability of letermovir in pediatric participants from birth to less than 18 years of age at risk of de...
    Medical condition: Cytomegalovirus (CMV) infection in pediatric allogeneic HSCT recipients
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10011831 Cytomegalovirus infection PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) Outside EU/EEA FR (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2022-001514-18 Sponsor Protocol Number: Cypher-TX_Pilot Start Date*: 2022-09-12
    Sponsor Name:University Medical Center Ljubljana
    Full Title: Cytomegalovirus Prophylaxis with Letermovir in Heart Transplant Recipients: A Non-randomized Cohort Pilot Study
    Medical condition: The focus of investigation in the proposed study protocol is the rates of Cytomegalovirus viremia and/or disease in patients after heart transplantation undergoing novel CMV prophylaxis protocol us...
    Disease:
    Population Age: Gender: Male, Female
    Trial protocol: SI (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-001055-30 Sponsor Protocol Number: MK8228-002 Start Date*: 2018-04-09
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention of Human Cytomegalovir...
    Medical condition: Prevention of CMV disease in D+/R- kidney transplant recipients
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10011831 Cytomegalovirus infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) AT (Completed) FR (Completed) HU (Completed) GB (GB - no longer in EU/EEA) BE (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-003831-31 Sponsor Protocol Number: 8228-001 Start Date*: 2014-04-23
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
    Full Title: A Phase III Randomized, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-8228 (Letermovir) for the Prevention of Clinically Significant Human Cytomegalovirus (CMV) Infect...
    Medical condition: Clinically significant CMV infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) LT (Completed) IT (Completed) FI (Completed) AT (Completed) ES (Completed) BE (Completed) PL (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-001038-17 Sponsor Protocol Number: MK-8228-040 Start Date*: 2019-05-02
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
    Full Title: A Phase 3 randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of letermovir (LET) prophylaxis when extended from 100 days to 200 days post transplant in ...
    Medical condition: Cytomegalovirus (CMV) infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10011831 Cytomegalovirus infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) ES (Prematurely Ended) FR (Completed) IT (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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