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    Summary
    EudraCT Number:2006-005692-18
    Sponsor's Protocol Code Number:1263-300
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-02-12
    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 ConcernedSweden - MPA
    A.2EudraCT number2006-005692-18
    A.3Full title of the trial
    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 STEM CELL TRANSPLANTS.
    A.4.1Sponsor's protocol code number1263-300
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorViroPharma 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameMaribavir
    D.3.2Product code VP 41263
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNmaribavir
    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 number100
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboCoated tablet
    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
    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.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10009701
    E.1.2Term CMV
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this study are to evaluate the efficacy of the prophylactic use of maribavir administered orally for up to 12 weeks for the prevention of cytomegalovirus disease in recipients of allogeneic stem cell transplants and to evaluate the safety and tolerability of the prophylactic use of maribavir administered orally for up to 12 weeks in this subject population.
    E.2.2Secondary objectives of the trial
    Secondary objective of the trial is to evaluate the pharmacokinetics of maribavir in this subject population.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title of sub-study is the same as main protocol title.
    A substudy to evaluate CMV-specific immunity will be conducted at selected investigative sites. Substudy procedures require the collection of additional blood samples at selected time points. The details of this substudy are provided in Appendix X of the protocol.
    Within EU no investigational sites will participate in this substudy.
    E.3Principal inclusion criteria
    Subjects must:
    * Be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed.
    * Be at least 18 years of age.
    * Weigh at least 40 kg.
    * Have undergone allogeneic bone marrow, peripheral blood stem cell, or cord blood transplantation (transplant may be related or unrelated, T-cell depleted or non-T-cell depleted, myeloablative or non-myeloablative/reduced intensity).
    * Have positive pre-transplantation CMV serology (recipient seropositive) or receive stem cells from a donor with positive pre-transplantation CMV serology (donor seropositive). I.e.,:
    Donor positive / Recipient positive (D+ R+), or
    Donor negative / Recipient positive (D– R+), or
    Donor positive / Recipient negative (D+ R–)
    * Have no detectable CMV infection post-transplant (unequivocally negative pp65 antigenemia and plasma CMV DNA PCR assays) from samples collected within 5 days prior to initiation of study drug (results from either the central laboratory or a local laboratory can be used for qualification).
    * Have transplant engraftment (absolute neutrophil count 500/mm3 [0.5 x 109/L] from 3 consecutive samples taken on separate days).
    * Be randomized such that dosing with study drug can begin between 14 days and 30 days post-transplant (inclusive).
    * If female, be either postmenopausal, surgically sterile, or have a negative serum pregnancy test within 5 days prior to initiation of study drug. Women of child bearing potential also must agree to use an acceptable method of birth control (e.g., abstinence, IUD, or barrier method), as determined by the investigator, during the study drug administration period and for 2 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 (e.g., abstinence or barrier method), as determined by the investigator, during the study drug administration period and for 2 months afterward.
    * Be able to swallow tablets.
    E.4Principal exclusion criteria
    * Have CMV-related organ disease within 6 months prior to randomization.
    * Have received any of the following therapies after the day of stem cell
    transplantation and prior to initiation of study drug:
    ganciclovir
    valganciclovir
    foscarnet
    cidofovir
    acyclovir (>25 mg/kg IV per day)
    valacyclovir (>3 g p.o. per day)
    famciclovir (>1500 mg p.o. per day)
    cytomegalovirus immune globulin
    * Have known human immunodeficiency virus (HIV) infection.
    * Be receiving therapy with phenytoin at time of enrollment.
    * Have any of the following findings within 5 days prior to initiation of study drug:
    Serum AST or ALT > 7 x the upper limit of normal
    Serum total bilirubin > 3 x the upper limit of normal
    * Have severe vomiting, diarrhea or other severe gastrointestinal illness within 24 hours prior to the time of randomization that would preclude administration of oral medication (subjects with active gastrointestinal graft-versus-host disease are allowed only if oral medications are permissible and the investigator determines that this condition is stable or improving).
    * Require mechanical ventilation, vasopressors for hemodynamic support, or dialysis at the time of randomization.
    * Be pregnant (as determined by -hCG testing prior to initiation of study drug) or breastfeeding.
    * Have received any investigational antiviral drug within 30 days before the initiation of study drug.
    * Have received maribavir in a previous clinical trial.
    * Have any clinically significant medical or surgical condition (other than the underlying reason for transplantation) that in the investigator’s or sponsor’s opinion would compromise the outcome of the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the incidence of CMV disease (as adjudicated by the independent Endpoint Committee) within 180 days post-transplant. The incidence of CMV disease also will be evaluated within 100 days and 12 months post-transplant.
    Key secondary endpoints will include incidence of initiation of preemptive anti-CMV therapy, incidence of graft-versus-host disease, mortality, and CMV disease-free survival. Additional efficacy endpoints will include incidence of CMV infection as assessed by CMV surveillance assays and time of onset of CMV infection or CMV disease.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    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 months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 613
    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)
    All subjects who end their participation in the trial will continue to be monitored by their respective physicians, using standard medical care. No special procedures or extra medical care is needed after the trial that would not be otherwise used in patients who have not participated in the trial.
    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 Decision2007-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-04-30
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