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    Summary
    EudraCT Number:2014-004458-33
    Sponsor's Protocol Code Number:CMX001-205
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-01-15
    Trial 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 number2014-004458-33
    A.3Full title of the trial
    An Open-Label, Multicenter Study of the Safety, Tolerability and Antiviral Activity of Brincidofovir (CMX001) for Treatment of Ebola Virus Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study is to determine whether CMX001 can be a treatment for Ebola Virus (EBOV) , if CMX001 is well tolerated in patients with EBOV, and to determine the blood levels of CMX001 in patients with EBOV
    A.4.1Sponsor's protocol code numberCMX001-205
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02271347
    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 UK Limited
    B.1.3.4CountryUnited Kingdom
    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, North Carolina
    B.5.3.3Post code27713
    B.5.3.4CountryUnited States
    B.5.6E-mailclinical@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.3.9.3Other descriptive nameCMX001 / BRINCIDOFOVIR
    D.3.9.4EV Substance CodeSUB130888
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ebola Virus Disease
    E.1.1.1Medical condition in easily understood language
    Ebola Virus Disease
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10014071
    E.1.2Term Ebola disease
    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 evaluate the safety and tolerability of CMX001 when administered for the treatment of
    EVD
    E.2.2Secondary objectives of the trial
    • To assess the effect of CMX001 treatment on survival in subjects with EVD through
    28 days post-initiation of CMX001 therapy

    • To describe the effect of CMX001 treatment on clinical outcomes (clinical progression
    defined as worsening of existing signs and symptoms; clinical improvement defined
    as improvement of clinical signs and symptoms; clinical resolution defined as resolution of clinical signs and symptoms) in patients treated for EVD

    • To describe the virologic response (blood and stool EBOV viral load as measured by
    polymerase chain reaction [PCR] assay) to CMX001 treatment in subjects with EVD

    • To evaluate the association between the virologic response and subject survival

    • To characterize the emergence of viral resistance in CMX001-treated subjects with EVD

    • To describe the plasma concentrations of BCV and CDV in CMX001-treated subjects
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, aged 2 months and older.

    2. Have at least one positive EBOV PCR test (any body fluid) from the local virology laboratory.

    3. Able to ingest and absorb oral medication (in the judgment of the investigator and based on lack of significant GI events/medical history).
    [Note: With the prior approval of the Chimerix medical monitor (or designee), subjects who can be dosed using liquid suspension formulation or dispersed tablet through a gastrostomy tube or other feeding tube that allows study drug to be delivered directly into the subject’s stomach or intestine may be enrolled in the study. Intrajejunal delivery of CMX001 is not advised as no PK or tolerability data are available for this route of administration.]

    4. If a male of reproductive potential, willing to use an acceptable contraceptive method(s) during sexual intercourse with a female partner of reproductive potential throughout the duration of his participation in the study and for at least 6 months after the last CMX001 dose administration.

    5. If a female of reproductive potential, i.e., not premenarche, postmenopausal, surgically sterile, or documented ovarian failure, willing to use two acceptable contraceptive methods, one of which must be a barrier method, during sexual intercourse with a non-sterile male partner, throughout the duration of her participation in the study and for at least 6 months after the last CMX001 dose administration.
    [Note: For assessing inclusion criterion 4 or 5, a promise to abstain from sexual intercourse is not an acceptable method of preventing pregnancy for the purposes of this study. However, subjects who are currently sexually abstinent and who indicate a willingness to use an acceptable contraceptive method(s), as described above, should they begin or resume sexual activity may be enrolled into the study.]

    6. Willing and able to understand and provide written informed consent to participate in the study.
    [Note: If the subject is under 18 years of age or is otherwise unable to legally give his or her informed consent to participate in the study, then written informed consent to participate must be obtained from the parent(s) or legal guardian(s) of the subject or other legal personal representative(s), as applicable. In addition, in the case of minor subjects, the written assent of the subject to participate in the study should be obtained where required by applicable institutional policy on the consenting of minor study participants.]

    7. Willing and able to participate in all required study activities for the entire duration of the study (i.e., through completion of the posttreatment follow-up period).
    E.4Principal exclusion criteria
    1. If a female of reproductive potential, the subject is pregnant, planning to become pregnant during the anticipated duration of her participation in the study (i.e., through completion of the posttreatment follow-up period), or nursing a child.

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

    3. Subjects who have received treatment with another investigational anti-EBOV medication or therapy (other than supportive care or transfusion with convalescent blood, plasma, or serum) unless prior approval has been received from the Chimerix medical monitor (or designee).

    4. Subjects who are participating in another interventional clinical trial unless prior approval has been received from the Chimerix medical monitor (or designee).

    5. Subjects who are receiving digoxin or ketoconazole (other than topical formulations) at Day 1 or who are anticipated to need treatment with either drug during the treatment phase of the study.

    6. Subjects with end-stage renal disease, i.e., an estimated glomerular filtration rate (eGFR) < 15 mL/min, unless receiving renal replacement therapy (RRT).

    7. 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)
    The primary endpoint will be the incidence of all-cause mortality through Day 29 (i.e., 28 days post-initiation of CMX001 therapy).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated through Day 29.
    E.5.2Secondary end point(s)
    Time to all-cause mortality through Day 29
    • Incidence of and time to all-cause mortality through Day 15 (i.e., 14 days post-initiation of CMX001 therapy)

    • Number and percentage of subjects who achieve a sustained (confirmed) clearance of blood EBOV RNA by PCR. For the purposes of this protocol, a sustained (confirmed) clearance of blood EBOV RNA is defined as two consecutive undetectable PCR results at least three days apart.

    • Time to clear EBOV RNA by PCR from all body compartments (e.g., blood, stool)

    • Correlation between virologic response and subject survival

    • Correlation between time from onset of symptoms and survival

    • Correlation between clinical symptoms at first dose (e.g., presence or absence of diarrhea) and survival

    • Emergence of viral resistance

    Additional Safety Endpoints include:

    • Incidence of treatment-emergent adverse events (TEAEs), in particular TEAEs of ≥ Grade 3 severity, as defined by the NIH/NCI CTCAE

    • Incidence and severity of treatment-related TEAEs

    • Incidence of SAEs

    • Incidence of TEAEs leading to CMX001 dose interruption

    • Incidence of permanent discontinuation from CMX001 due to TEAEs

    Additional PK Endpoints include:

    • Plasma concentrations of CMX001 and CDV

    • Plasma PK parameters for CMX001 and CDV following first dose administration
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time to all-cause mortality through Day 29.
    Incidence of and time to all-cause mortality through Day 15.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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 EEA9
    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
    Netherlands
    Norway
    Spain
    Sweden
    Switzerland
    United Kingdom
    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 Lase Subject (LVLS)
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 3
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 1
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 1
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 7
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    If the subject is unable to legally give his/her informed consent to participate in the study, then written informed consent must be obtained from the parent(s) or legal guardian(s) or other legal personal representative(s), as applicable.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 50
    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)
    At the end of the posttreatment period, subjects will be encouraged to participate in the Chimerix CMX001 Registry (Chimerix Study CMX001-333) to assess the longer-term impact of BCV administration on malignancy and survival. While Registry participation is encouraged, subjects will not be required to participate in the Registry order to participate in the current study.
    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 Decision2014-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-02-03
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