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    The EU Clinical Trials Register currently displays   42517   clinical trials with a EudraCT protocol, of which   7000   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2010-024247-32
    Sponsor's Protocol Code Number:1263-203
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-03
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2010-024247-32
    A.3Full title of the trial
    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 WHO DO NOT HAVE CMV ORGAN DISEASE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to determine how safe and effective maribavir versus Valganciclovir is in treating cytomegalovirus(CMV) in transplant patients



    A.4.1Sponsor's protocol code number1263-203
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorShire ViroPharma Incorporated
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportShire ViroPharma Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShire ViroPharma Incorporated
    B.5.2Functional name of contact pointClinical Study Manager
    B.5.3 Address:
    B.5.3.1Street AddressRue Montoyer 47
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post codeB-1000
    B.5.3.4CountryBelgium
    B.5.4Telephone number003223007811
    B.5.5Fax number003227062421
    B.5.6E-mailkdanneels@shire.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMarabavir
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmarabavir
    D.3.9.1CAS number 176161-24-3
    D.3.9.2Current sponsor codeVP 41263
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Valcyte
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Products Limited
    D.2.1.2Country which granted the Marketing AuthorisationRomania
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVALGANCICLOVIR
    D.3.9.1CAS number 175865-60-8
    D.3.9.4EV Substance CodeSUB00007MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number450
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    CMV INFECTIONS IN TRANSPLANT RECIPIENTS
    E.1.1.1Medical condition in easily understood language
    CMV INFECTIONS IN TRANSPLANT RECIPIENTS
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10021819
    E.1.2Term Infection in marrow transplant recipients
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10021829
    E.1.2Term Infection in solid organ transplant recipients
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety and tolerability of different doses of maribavir versus valganciclovir, administered orally for up to 12 weeks, for treatment of CMV infections in recipients of stem cell or solid organ transplants who do not have CMV organ disease.
    To assess the antiviral activity of different doses of maribavir versus valganciclovir in this subject population.
    E.2.2Secondary objectives of the trial
    To evaluate the pharmacokinetics and pharmacodynamics of maribavir in this subject population.
    To identify a maribavir dosing regimen for treatment of CMV infections in future studies.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Be ≥18 years of age.
    2. Be a recipient of stem cell or solid organ transplantation.
    3. Have documented CMV infection in blood or plasma, with a screening value of ≥1,000 to ≤100,000 DNA copies/mL as determined by quantitative PCR or comparable quantitative CMV assay type. Results from either the central laboratory or a local laboratory can be used for qualification.
    4. Have CMV infection that does not meet the definition of CMV organ disease at the time of enrollment (see Appendix IV).
    5. Have a CMV infection that is not known to be resistant to ganciclovir/valganciclovir, foscarnet, or cidofovir based on genotypic evidence.
    6. Have all of the following findings as part of screening laboratory assessment (results from either the central laboratory or a local laboratory can be used for qualification):
    • Absolute neutrophil count (ANC ≥500/mm3 [0.5 x 109/L]
    • Platelet count ≥25,000/mm3 [25 x 109/L]
    • Hemoglobin ≥8 g/dL
    7. If female, be either postmenopausal, surgically sterile, or have a negative pregnancy test as part of screening laboratory assessments (pregnancy test results from either the central laboratory or a local laboratory can be used for qualification). Women of child bearing potential also must agree to use an acceptable method of birth control, as determined by the investigator, during the study drug administration period and for 3 months afterward. Hormonal contraceptives should not be used as the sole method of birth control.
    If male, must agree to use an acceptable method of birth control, as determined by the investigator, during the study drug administration period and for 3 months afterward.
    8. Be able to swallow tablets.
    9. Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed. [NOTE: Subjects must be fully able to give their consent.]
    10. Be assessed by the investigator to determine whether prophylaxis for non-CMV herpesvirus infections (e.g., herpes simplex virus [HSV type I and type II] and varicella zoster virus [VZV]) is appropriate according to institutional guidelines or standard practices, keeping in mind that maribavir is not active in vitro against these viruses.
    E.4Principal exclusion criteria
    Subjects must not:
    1. Be receiving any of the following therapies when study drug is initiated:
    • ganciclovir
    • valganciclovir
    • foscarnet
    • cidofovir
    • CMV immune globulin (CMV-IGIV, Cytogam®)
    • leflunomide
    • artesunate
    NOTE: A subject may have received any of the above listed drugs prior to enrollment. If this is the case, these drugs must be discontinued, and a “washout” period of ≥24 hours is required between the last dose and commencement of dosing with study drug.
    2. Have known allergies to one of the study medications (e.g., valganciclovir) or its excipients.
    3. Have estimated creatinine clearance (CrCl) <10 mL/min or require dialysis when study drug is initiated.
    4. Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the first dose of study drug that would preclude administration of oral/enteral medication.
    5. Require mechanical ventilation or vasopressors for hemodynamic support at the time of enrollment.
    6. Have any serious illness with expected survival less than 6 weeks.
    7. Be pregnant (as determined by β-human chorionic gonadotropin testing prior to initiation of study drug) or breastfeeding.
    8. Have received any investigational (unapproved) agent with known anti-CMV
    activity within 30 days before initiation of study drug.
    9. Have any clinically significant medical or surgical condition that in the investigator’s or sponsor’s opinion could interfere with the administration of study drug or interpretation of study results, or compromise the safety or wellbeing of the subject.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of the study is to evaluate the safety and tolerability of different doses of maribavir versus valganciclovir in the study population. The primary analysis of safety will be the evaluation of treatment-emergent adverse events (TEAEs), defined as all AEs that start during the study drug treatment period (and up to 7 days after the last dose of the study drug) and were not seen at baseline, or were seen at baseline but increased in frequency and/or severity during the study drug treatment period (and up to 7 days after the last dose of study drug).
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days after the last dose of the study
    E.5.2Secondary end point(s)
    Efficacy analyses will focus primarily on the antiviral effect of the study drug treatments on plasma CMV DNA concentrations within 3 and 6 weeks; corresponding endpoints will be evaluated using modeling analyses.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 144
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 160
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard of Care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-25
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