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Clinical trials for Maribavir

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    8 result(s) found for: Maribavir. Displaying page 1 of 1.
    EudraCT Number: 2022-002191-36 Sponsor Protocol Number: TAK-620-1019 Start Date*: 2022-07-18
    Sponsor Name:Shire
    Full Title: A Phase 1, Open-label, Randomized, Crossover, Bioavailability, Dose Proportionality, and Food Effect Study Comparing the Pharmacokinetics and Palatability of Two Candidate Pediatric Powder-for-Oral...
    Medical condition: Healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-002374-82 Sponsor Protocol Number: TAK-620-3001 Start Date*: 2022-11-21
    Sponsor Name:Takeda
    Full Title: A Phase 3, Open-Label, Single-Arm Study to Assess the Efficacy, Safety, and Pharmacokinetics of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Japanese Recipients of a Hematopoie...
    Medical condition: Cytomegalovirus Infection in Hematopoietic Stem Cell Transplant or Solid Organ Transplant Recipients
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10011831 Cytomegalovirus infection PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-004279-15 Sponsor Protocol Number: TAK-620-2004 Start Date*: 2022-09-02
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Phase 3, open-label, single-arm, repeated-dose study to evaluate the safety and tolerability, pharmacokinetics, and antiviral activity of maribavir for the treatment of cytomegalovirus (CMV) in...
    Medical condition: Cytomegalovirus (CMV) infection in children and adolescents who have received a hematopoietic stem cell transplant (HSCT) or a solid organ transplant (SOT)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10021829 Infection in solid organ transplant recipients LLT
    20.0 100000004862 10021819 Infection in marrow transplant recipients LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Trial now transitioned) DE (Trial now transitioned) Outside EU/EEA FR (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-024247-32 Sponsor Protocol Number: 1263-203 Start Date*: 2012-03-09
    Sponsor Name:VIROPHARMA INCORPORATED
    Full Title: A PHASE 2, RANDOMIZED, DOSE-RANGING STUDY TO ASSESS THE SAFETY AND ANTI-CYTOMEGALOVIRUS (CMV) ACTIVITY OF MARIBAVIR VERSUS VALGANCICLOVIR FOR TREATMENT OF CMV INFECTIONS IN TRANSPLANT RECIPIENTS WH...
    Medical condition: CMV INFECTIONS IN TRANSPLANT RECIPIENTS
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10021819 Infection in marrow transplant recipients LLT
    14.1 100000004862 10021829 Infection in solid organ transplant recipients LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) FR (Completed) AT (Completed) ES (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-004726-34 Sponsor Protocol Number: SHP620-302 Start Date*: 2017-09-01
    Sponsor Name:Takeda Development Center Americas, Inc.
    Full Title: A Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study to assess the efficacy and safety of maribavir compared to valganciclovir for the treatment of cytomegaloviru...
    Medical condition: Cytomegalovirus Infection in Hematopoietic Stem Cell Transplant Recipients
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10021819 Infection in marrow transplant recipients LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed) GB (GB - no longer in EU/EEA) ES (Completed) BE (Completed) CZ (Completed) PL (Completed) FR (Completed) HR (Completed) IT (Completed) GR (Completed) AT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-005692-18 Sponsor Protocol Number: 1263-300 Start Date*: 2007-07-24
    Sponsor Name:ViroPharma Incorporated
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF PROPHYLACTIC USE OF MARIBAVIR FOR THE PREVENTION OF CYTOMEGALOVIRUS DISEASE IN RECIPIENTS OF ALLOGENEIC STE...
    Medical condition: Main purpose is to assess the efficacy and safety of prophylactic use of Maribavir to prevent cytomegalovirus disease in recipients of allogeneic stem cell transplants.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10009701 CMV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) BE (Completed) FR (Completed) GB (Prematurely Ended) DE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-004729-16 Sponsor Protocol Number: 1263-301 Start Date*: 2008-01-25
    Sponsor Name:ViroPharma Incorporated
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF PROPHYLACTIC USE OF MARIBAVIR VERSUS ORAL GANCICLOVIR FOR THE PREVENTION OF CYTOMEGALOVIRUS DISEASE IN RECE...
    Medical condition: Main purpose is to assess the efficacy and safety of prophylactic use of oral Maribavir versus oral Ganciclovir to prevent cytomegalovirus disease in recipients of orthotopic liver transplants at h...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10009701 CMV LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) FR (Completed) GB (Prematurely Ended) AT (Completed) DE (Completed) BE (Completed) ES (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-004725-13 Sponsor Protocol Number: SHP620-303 Start Date*: Information not available in EudraCT
    Sponsor Name:Shire ViroPharma Incorporated
    Full Title: A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients...
    Medical condition: CMV infections resistant or refractory in transplant patients
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10021819 Infection in marrow transplant recipients LLT
    20.0 100000004862 10021829 Infection in solid organ transplant recipients LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) BE (Completed) ES (Completed) FR (Completed) AT (Completed) HR (Completed) IT (Completed) DK (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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