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    Summary
    EudraCT Number:2013-004795-35
    Sponsor's Protocol Code Number:CMX001-301
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-02-24
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2013-004795-35
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Phase 3 Study of the Safety, Tolerability, and Efficacy of CMX001 for the Prevention of Cytomegalovirus (CMV) Infection in CMV-seropositive (R+) Hematopoietic Stem Cell Transplant Recipients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study is to compare the effectiveness of CMX001 to placebo for the prevention of Cytomegalovirus infection in stem cell transplant patients.


    A.3.2Name or abbreviated title of the trial where available
    SUPPRESS
    A.4.1Sponsor's protocol code numberCMX001-301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01769170
    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 SponsorChimerix, Inc.
    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 supportChimerix, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChimerix, Inc.
    B.5.2Functional name of contact pointMain Phone Number
    B.5.3 Address:
    B.5.3.1Street Address2505 Meridian Parkway Suite 340
    B.5.3.2Town/ cityDurham, NC
    B.5.3.3Post code27713
    B.5.3.4CountryUnited States
    B.5.4Telephone number1919 806 1074
    B.5.6E-mailclinicaltrials@chimerix.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 nameCMX001/brincidofovir
    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 INNbrincidofovir (USAN)
    D.3.9.1CAS number 444805-28-1
    D.3.9.2Current sponsor codeCMX001
    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) 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
    Cytomegalovirus (CMV) Infection
    E.1.1.1Medical condition in easily understood language
    Cytomegalovirus Infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10011831
    E.1.2Term Cytomegalovirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of CMX001 to placebo for the prevention of clinically significant CMV infection in R+ allogeneic hematopoietic stem cell transplant (HSCT) recipients
    To compare the safety and tolerability of CMX001 to placebo for the prevention of clinically significant CMV infection in R+ allogeneic HSCT recipients
    E.2.2Secondary objectives of the trial
    To describe the effect of CMX001 versus placebo on mortality, and graft failure.
    To evaluate the virologic response and the emergence of resistance.
    To characterize the effect of CMX001 in preventing clinical manifestations associated with non-CMV double-stranded deoxyribonucleic acid viruses.
    To describe plasma concentrations of CMX001 and cidofovir (CDV).
    To compare health economic and health-related quality-of-life outcome parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Allogeneic HSCT recipient who has prior evidence of CMV exposure before transplantation and who is CMV viremia negative at screening and at any other assessments performed prior to the FDD.

    2. Aged ≥ 18 years.

    3. If male, willing to use an acceptable contraceptive method(s) throughout the duration of his participation in the study, i.e., through Week 24.

    4. If female, either postmenopausal, surgically sterile or, for those female subjects of reproductive potential with a non-sterile male partner, willing to use two acceptable contraceptive methods, one of which must be a barrier method, throughout the duration of her participation in the study, i.e., through Week 24.

    5. Able to begin study drug dosing within 28 days following HSCT.

    6. Able to ingest and absorb oral medication (in the judgment of the investigator and based on lack of significant GI events/medical history).

    7. Willing and able to understand and provide written informed consent.

    8. Willing and able to participate in all required study activities for the entire duration of the study (i.e., through Week 24).
    E.4Principal exclusion criteria
    1. If female, the subject is pregnant or planning to become pregnant during the anticipated duration of her participation in the study (i.e., through Week 2), or nursing a child.

    2. Subjects who have a positive CMV viremia test (through central or local virology laboratory) at any time between transplant and the FDD.

    3. Subjects who weigh ≥ 120 kg (~ 265 lbs.).

    4. Subjects with hypersensitivity (not renal dysfunction or eye disorder) to CDV or to CMX001 or its excipients.

    5. Subjects who have received any of the following:
    - GCV, vGCV, FOS, CDV, or any other anti-CMV therapy [including CMV
    immune globulin (CMV Ig), cell-based therapies, and investigational anti-CMV drugs, e.g., leflunomide, letermovir (previously AIC246), or maribavir] at any time posttransplant;
    - any anti-CMV vaccine at any time;
    - any other investigational drug within 14 days prior to the FDD (unless prior approval has been received from the Chimerix Medical Monitor or designee), or
    -prior treatment with CMX001 at any time.

    6. Subjects receiving acyclovir (ACV) orally at > 2,000 mg total daily dose (TDD) or intravenously at > 5 mg/kg three times daily (TID), valacyclovir (vACV) at > 3,000 mg TDD or leflunomide at any dose on the FDD or who are anticipated to receive any of these drugs at the doses described after the FDD.

    7. Subjects who are receiving digoxin at the FDD or are anticipated to need treatment with digoxin during the treatment phase (through Week 14).

    8. Subjects with possible, probable or definitive CMV disease diagnosed within 6 months prior to the FDD.

    9. Subjects who are HIV-infected (based on serology), or who have an active HCV or HBV infection as evidenced by detectable plasma HCV ribonucleic acid (RNA) or HBV DNA, respectively.

    10. Subjects who have received another allogeneic HSCT (i.e., other than the qualifying HSCT) within 2 years prior to the FDD.

    11. Subjects with renal insufficiency, as evidenced by an eGFR < 15 mL/min or requiring hemodialysis.

    12. Subjects with hepatic abnormalities as evidenced by a screening ALT or AST > 5x ULN as reported by the central safety laboratory.

    13. Subjects with a screening total bilirubin > 2x ULN and direct bilirubin > 1.5x ULN as reported by the central safety laboratory.

    14. Subjects with active solid tumor malignancies with the exception of basal cell carcinoma or the underlying condition necessitating the stem cell transplant (e.g., lymphomas).

    15. Subjects with Stage 2 or higher GI-GVHD or any other GI disease that would, in the judgment of the investigator, preclude the subject from taking or absorbing oral medication (e.g., clinically active Crohn’s disease, ischemic colitis, moderate or severe ulcerative colitis, small bowel resection, ileus, or any condition expected to require
    abdominal surgery during the course of study participation).

    16. Any other condition, including abnormal laboratory values, that would, in the judgment of the investigator, put the subject at increased risk by participating in the study, or would interfere with the conduct or planned analyses of the study.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    The primary efficacy endpoint of this study will be the incidence of clinically significant CMV infection through Week 24.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated through week 24.
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    - To describe the effect of CMX001 versus placebo on all cause mortality,non-relapse mortality and on graft failure
    - The effect of CMX001 in preventing clinical manifestations associated with non-CMV double-stranded deoxyribonucleic acid (dsDNA) viruses including BKV, HHV-6, AdV and EBV.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy and safety analysis will assess relevant clinical events through dosing (week 14) and follow up (week 24)
    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 Yes
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality Of Life
    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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    France
    Germany
    United States
    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
    Last Visit of the Last Subject (LVLS)
    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 months1
    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 months1
    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: 360
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 450
    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)
    None
    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 Decision2014-03-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-02
    P. End of Trial
    P.End of Trial StatusCompleted
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