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    Summary
    EudraCT Number:2017-003984-37
    Sponsor's Protocol Code Number:CMX001-211
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-11-05
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-003984-37
    A.3Full title of the trial
    A Randomized, Controlled, Open-Label, Multiple Ascending Dose Study of Intravenous Brincidofovir in Adult Allogeneic Hematopoietic Cell Transplant Recipients with Adenovirus Viremia
    Studio randomizzato, controllato, in aperto, a dose multipla crescente di brincidofovir endovena in adulti riceventi trapianto allogenico di cellule emopoietiche affetti da viremia da adenovirus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Safety of Intravenous Brincidofovir for Adenovirus Infection
    Studio sulla sicurezza di brincidofovir endovena per infezione da adenovirus
    A.3.2Name or abbreviated title of the trial where available
    A Study of the Safety of Intravenous Brincidofovir for Adenovirus Infection
    Studio sulla sicurezza di brincidofovir endovena per infezione da adenovirus
    A.4.1Sponsor's protocol code numberCMX001-211
    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 pointChief Medical Officer
    B.5.3 Address:
    B.5.3.1Street Address2505 Meridian Parkway, Suite 100
    B.5.3.2Town/ cityDurham
    B.5.3.3Post codeNC 27713
    B.5.3.4CountryUnited States
    B.5.6E-mailCMX001211ivstudy@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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/070/16
    D.3 Description of the IMP
    D.3.1Product nameBrincidofovir
    D.3.2Product code CMX001
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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.3.9.4EV Substance CodeSUB130888
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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 Cidofovir Tillomed
    D.2.1.1.2Name of the Marketing Authorisation holderTillomed Laboratories Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameCidofovir
    D.3.2Product code [-]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCIDOFOVIR
    D.3.9.1CAS number 113852-37-2
    D.3.9.2Current sponsor codeCidofovir
    D.3.9.4EV Substance CodeSUB06257MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    Treatment of adenovirus infections in adult allogeneic hematopoietic cell transplant recipients
    Trattamento delle infezioni da adenovirus in pazienti adulti riceventi trapianto allogenico di cellule emopoietiche
    E.1.1.1Medical condition in easily understood language
    Treatment of adenovirus infections in adults after allogeneic hematopoietic cell transplant
    Trattamento delle infezioni da adenovirus in pazienti adulti in seguito a trapianto allogenico di cellule emopoietiche
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10060931
    E.1.2Term Adenovirus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety and pharmacokinetics (PK) of selected doses of brincidofovir (BCV) administered intravenously (IV) in allogeneic hematopoietic cell transplant (HCT) recipients with adenovirus (AdV) viremia.
    Valutare la sicurezza e la farmacocinetica (PK) di dosi selezionate di brincidofovir (BCV) somministrato per via endovenosa (e.v.) a riceventi di trapianto allogenico di cellule emopoietiche (HCT) affetti da viremia da adenovirus (AdV).
    E.2.2Secondary objectives of the trial
    ¿ To assess the clinical safety of IV BCV with respect to adverse events (AEs) and changes in laboratory parameters.
    ¿ To assess PK of BCV and cidofovir (CDV) in plasma and CDV diphosphate (CDV-PP) in peripheral blood mononuclear cells (PBMCs) and red blood cells (RBCs) following multiple IV doses of BCV.
    ¿ To evaluate the virologic response, based on change from baseline in AdV deoxyribonucleic acid (DNA) in plasma, stool and/or urine and incidence of undetectable AdV viremia, of the selected IV BCV doses in HCT recipients.
    ¿ Valutare la sicurezza clinica di BCV e.v. in termini di eventi avversi (AE) e variazioni dei parametri di laboratorio.
    ¿ Valutare la PK di BCV e cidofovir (CDV) nel plasma e di CDV difosfato (CDV-PP) nelle cellule mononucleate di sangue periferico (PBMC) e negli eritrociti (RBC) dopo multiple dosi e.v. di BCV.
    ¿ Valutare la risposta virologica, basata sulla variazione dal basale dell'acido deossiribonucleico (DNA) dell'AdV nel plasma, nelle feci e/o nelle urine e l'incidenza di viremia AdV non rilevabile, di dosi e.v. selezionate di BCV in soggetti riceventi di HCT.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in this study, subjects must:
    1. Be = 18-years-old (or per local law or regulations on legal age of consent).
    2. Have received an allogeneic HCT within the previous 100 days.
    3. Have plasma AdV DNA viremia = 1,000 copies/mL (via quantitative polymerase chain reaction assay; local results must be confirmed by the designated central virology laboratory).
    Per essere inclusi in questo studio i soggetti devono:
    1. Avere un'età = 18 anni (o l'età legale per accordare il consenso secondo la legge e le normative locali).
    2. Aver ricevuto un HCT allogenico nei 100 giorni precedenti.
    3. Presentare = 1.000 copie/mL di viremia AdV DNA nel plasma (misurata mediante dosaggio quantitativo della reazione a catena della polimerasi; i risultati locali devono essere confermati dal laboratorio di virologia centrale designato).
    E.4Principal exclusion criteria
    1. Diarrhea meeting the US National Institutes of Health (NIH)/National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater (i.e., increase of = 4 stools per day over usual pretransplant stool output) within 7 days prior to Day 1.
    2. Acute graft versus host disease (GVHD) meeting the following criteria:
    - NIH Stage 2 or higher acute GVHD of the gut (i.e., diarrhea > 1,000 mL/day, or severe abdominal pain with or without ileus) or liver (i.e., bilirubin > 3 mg/dL [SI: > 51 µmol/L]) within 7 days prior to Day 1.
    - Any NIH Stage 3 or Stage 4 acute GVHD within 7 days prior to Day 1.
    3. Concurrent human immunodeficiency virus or active hepatitis B or C infection.
    4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 5x the upper limit of the normal reference range (ULN), total bilirubin > 3 mg/dL (SI: > 51 µmol/L), or prothrombin time – international normalized ratio (PT-INR) > 2x ULN within 7 days prior to Day 1.
    1. Diarrea di grado 2 o superiore secondo i criteri CTCAE degli NIH/NCI (Common Terminology Criteria for Adverse Events di US National Institutes of Health/National Cancer Institute) (ossia aumento di = 4 defecazioni al giorno rispetto alla normale frequenza di defecazione pre trapianto) nei 7 giorni precedenti al Giorno 1.
    2. Malattia del trapianto contro l’ospite (GVHD) acuta che soddisfa i seguenti criteri:
    - GVHD acuta di stadio 2 o superiore secondo l'NIH dell'intestino (ossia diarrea > 1.000 mL/die o dolore addominale severo con o senza ileo) o del fegato (ossia bilirubina > 3 mg/dL [SI: > 51 µmol/L]) nei 7 giorni precedenti al Giorno 1.
    - Qualsiasi GVHD acuta di stadio 3 o 4 secondo l'NIH nei 7 giorni precedenti al Giorno 1.
    3. Infezione concomitante da virus dell’immunodeficienza umana o infezione attiva da virus dell’epatite B o C.
    4. Alanina aminotransferasi (ALT) o aspartato aminotransferasi (AST) superiore a 5 volte il limite superiore della norma (ULN), bilirubina totale > 3 mg/dL (SI: > 51 µmol/L) o tempo di protrombina - rapporto internazionale normalizzato (PT-INR) > 2 volte l'ULN nei 7 giorni precedenti al Giorno 1.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the safety and pharmacokinetics (PK) of selected doses of brincidofovir (BCV) administered intravenously (IV) in allogeneic hematopoietic cell transplant (HCT) recipients with adenovirus (AdV) viremia
    -
    E.5.1.1Timepoint(s) of evaluation of this end point
    To evaluate the safety and pharmacokinetics (PK) of selected doses of brincidofovir (BCV) administered intravenously (IV) in allogeneic hematopoietic cell transplant (HCT) recipients with adenovirus (AdV) viremia
    -
    E.5.2Secondary end point(s)
    ¿ Incidence of TEAEs, particularly those of = CTCAE Grade 3 severity and serious adverse events (SAEs).
    ¿ Absolute and changes over time in safety laboratory parameters (i.e., hematology and clinical chemistry).
    ¿ Plasma BCV Cmax, tmax, AUCt, AUClast, AUCinf, %AUCextrap, Clast, tlast, t¿, CL, Vz, and Vss following Dose 1 and Dose 4, as data permit.
    ¿ Change in AdV viremia from baseline.
    ¿ Relationship between plasma BCV exposure and virologic endpoints of interest and influence of various covariates of interest on the exposure-response relationships and endpoints.
    -
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety: through AEs
    Pharmacokinetics: Day 1 and Day 11
    Pharmacodynamics: Day 8 and 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 Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    -
    Standard of Care as per physician's choice
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    -
    Standard of Care as per physician's choice
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    Italy
    Spain
    United States
    E.8.7Trial has a data monitoring committee No
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months13
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months13
    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: 30
    F.1.3Elderly (>=65 years) No
    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 20
    F.4.2.2In the whole clinical trial 30
    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 as per physician's choice
    -
    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 Decision2018-08-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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