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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-001735-39
    Sponsor's Protocol Code Number:CMX001-999
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-12-21
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-001735-39
    A.3Full title of the trial
    An Open-label, Randomized, Multi-center, Parallel Group, Two-arm Study to Assess the Safety, Overall Tolerability, and Antiviral Activity of Brincidofovir versus Standard of Care for Treatment of Adenovirus Infections in High-risk Pediatric Allogeneic Hematopoietic Cell Transplant Recipients
    Estudio abierto, aleatorizado, multicéntrico, de grupos paralelos y de dos ramas para evaluar la seguridad, la tolerabilidad global y la actividad antiviral de brincidofovir frente al tratamiento convencional para el tratamiento de las infecciones causadas por adenovirus en pacientes pediátricos de alto riesgo que reciben un alotrasplante de células hematopoyéticas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to compare brincidofovir with current care for adenovirus infection in children after a bone marrow transplant
    Un estudio clínico para comparar brincidofovir frente al tratamiento habitual para la infección por adenovirus en niños después de un trasplante de médula ósea.
    A.3.2Name or abbreviated title of the trial where available
    AdAPT: Adenovirus after Allogeneic Pediatric Transplantation
    AdAPT: Adenovirus tras un alotrasplante en pacientes pediátricos
    A.4.1Sponsor's protocol code numberCMX001-999
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03339401
    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 Pkwy, Suite 100
    B.5.3.2Town/ cityDurham
    B.5.3.3Post codeNC 27713
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1919 287 6006
    B.5.5Fax number+1919 806 1146
    B.5.6E-mailAdAPT@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 numberEU/3/16/1697
    D.3 Description of the IMP
    D.3.1Product nameBrincidofovir
    D.3.2Product code CMX001
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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.3.9.3Other 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 number2
    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
    Treatment of adenovirus infections in high-risk (i.e., T cell depleted) pediatric allogeneic hematopoietic cell transplant recipients
    Tratamiento de las infecciones causadas por adenovirus (AdV) en pacientes pediátricos de alto riesgo (es decir, con depleción de los linfocitos T) que reciben un alotrasplante de células hemato poyéticas (alo-TCH).
    E.1.1.1Medical condition in easily understood language
    Treatment of adenovirus infection in children after a bone marrow transplant
    Tratamiento de la infección por adenovirus en niños después de un
    trasplante de médula ósea.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    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
    The primary objective of the study is to compare the safety, overall tolerability, and virologic response of BCV vs. SoC for the treatment of AdV infection in high-risk pediatric allogeneic HCT recipients.
    El objetivo principal del estudio es comparar la seguridad, la tolerabilidad global y la respuesta virológica de BCV frente al tratamiento convencional para la infección por AdV en pacientes pediátricos de alto riego que reciben un alo-TCH.
    E.2.2Secondary objectives of the trial
    • To assess the incidence of and time to all-cause, non-relapse, and AdV-associated mortality in pediatric subjects treated with BCV vs. SoC
    • To assess the correlation between virologic response and clinical outcome
    • To describe the incidence of and time to virologic relapse in subjects who have previously achieved undetectable AdV viremia
    •Evaluar la incidencia y el tiempo hasta la mortalidad por todas las causas, no asociada a una recidiva y asociada al AdV en sujetos pediátricos tratados con BCV frente al tratamiento convencional.
    •Evaluar la correlación entre la respuesta virológica y el desenlace clínico.
    •Describir la incidencia y el tiempo hasta la recidiva virológica en sujetos que previamente habían alcanzado una viremia por AdV indetectable.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Aged at least 2 months and less than 18-years-old on Day 1.
    • Have received a T cell-depleted allogeneic HCT within the previous 100 days.
    • First detectable AdV DNA plasma viremia since the qualifying transplant occurred within 21 days prior to Day 1.
    • AdV DNA plasma viremia ≥ 1000 copies/mL and rising, defined as two consecutive results ≥ 1000 copies/mL from the designated central virology laboratory, with the second result being greater than the first.
    •tener al menos 2 meses y menos de 18 años de edad el día 1.
    •haber recibido un alo-TCH (es decir, no autólogo) con depleción de los
    linfocitos T en los 100 días anteriores.
    •Desde el trasplante calificativo de los sujetos, la primera detección de AdV en plasma debe haber tenido lugar en los 21 días anteriores al día 1.
    •con una viremia por AdV en plasma confirmada de ≥1000 copias/ml y que va en aumento, lo que se define como dos resultados consecutivos de ADN del AdV con la técnica de reacción en cadena de la polimerasa (PCR, por sus siglas en inglés) ≥1000 copias/ml del laboratorio de virología central designado, siendo el segundo resultado mayor que el primero.
    E.4Principal exclusion criteria
    • Any CTCAE Grade 4 diarrhea (i.e., life-threatening consequences with urgent intervention indicated) within 7 days prior to Day 1.
    • Any CTCAE Grade 2 or 3 diarrhea (i.e., increase of ≥ 4 stools per day over baseline), unless attributed to AdV, within 7 days prior to Day 1.
    • NIH Stage 4 acute GVHD of the skin (i.e., generalized erythroderma with bullous formation) within 7 days prior to Day 1.
    • NIH Stage 2 or higher acute GVHD of the liver (i.e., bilirubin > 3 mg/dL [SI: > 51 μmol/L]) within 7 days prior to Day 1.
    • NIH Stage 2 or higher acute GVHD of the gut (i.e., diarrhea > 556 mL/m2/day, or severe abdominal pain with or without ileus) within 7 days prior to Day 1.
    • Active malignancy (with the exception of non-melanoma skin cancer), including relapse or progression of the underlying disease for which qualifying transplant was performed.
    • Use of vasopressors within 7 days prior to Day 1.
    • PT-INR > 2x upper limit of normal reference range (ULN) in the absence of anticoagulation within 7 days prior to Day 1.
    • Requirement for mechanical ventilation within 7 days prior to Day 1, or sustained oxygen delivery for > 24 hours within 7 days prior to Day 1, or any oxygen requirement within 48 hours prior to Day 1.
    • Estimated creatinine clearance < 30 mL/min or use of renal replacement therapy (e.g., hemodialysis, continuous renal replacement therapy, peritoneal dialysis) within 7 days prior to Day 1.
    • ALT > 5x ULN, AST > 5x ULN, or total bilirubin > 3 mg/dL [SI: > 51 μmol/L] within 7 days prior to Day 1.
    • Human immunodeficiency virus (HIV) infection as detected through any laboratory method (e.g., enzyme-linked immunosorbent assay, Western Blot, RNA PCR). [Note: Testing to confirm the absence of HIV infection is required at screening unless testing was performed by the local laboratory within 6 months prior to screening.].
    • Females who are pregnant or breastfeeding or planning to become pregnant within 90 days after their last anticipated dose of BCV.
    • Receiving or anticipated to receive medications prohibited in this protocol (see Section 8.6.1).
    • Hypersensitivity (not including renal dysfunction or eye disorder) to CDV or to BCV or its formulation excipients.
    • Participation in another interventional clinical trial unless prior approval has been received from the Chimerix Medical Monitor (or designee) (see Section 8.6.1.3).
    • Received any cell-based anti-AdV therapy within 6 weeks prior to Day 1 or previously received an anti-AdV vaccine at any time.
    • Diarrea de grado 4 según los CTCAE (es decir, consecuencias potencialmente mortales con indicción de una intervención urgente) en los 7 días anteriores al día 1.
    •Diarrea de grado 2 o 3 según los CTCAE (es decir, un aumento de ≥4
    deposiciones al día con respecto al valor basal), a menos que se atribuya al AdV, en los 7 días anteriores al día 1.
    •Enfermedad de injerto contra huésped (EICH) aguda de la piel en estadio 4 según los NIH (es decir, eritrodermia generalizada ampollosa) en los 7 días anteriores al día 1.
    •EICH aguda del hígado en estadio 2 o mayor según los NIH (es decir,
    bilirrubina >3 mg/dl [SI: >51 μmol/l]) en los 7 días anteriores al día 1.
    •EICH aguda del intestino en estadio 2 o mayor según los NIH (es decir,
    diarrea >556 ml/m2/día o dolor abdominal intenso con o sin íleo) en los
    7 días anteriores al día 1.
    •Mal pronóstico clínico (incluida una neoplasia maligna activa o el uso de
    vasopresores en los 7 días anteriores al día 1).
    •Necesidad de ventilación mecánica en los 7 días anteriores al día 1, o
    aporte continuado de oxígeno >24 horas en los 7 días anteriores al día 1
    o necesidad de oxígeno en las 48 horas anteriores al día 1.
    •Infección concurrente por el virus de la inmunodeficiencia humana
    (VIH) o infección activa por el virus de la hepatitis B o de la hepatitis C.
    •Resultados de laboratorio fuera del intervalo especificado (incluidos los
    valores de alanina aminotransferasa [ALAT] cinco veces más del límite
    superior de la normalidad [>5 veces el LSN], la aspartato aminotransferasa [ASAT] >5 veces el LSN, la bilirrubina total >3 mg/dl (SI: >51 μmol/l) o el tiempo de protrombina-cociente internacional normalizado [TP-INR] >2 veces el LSN) en los 7 días anteriores al día 1.
    •Aclaramiento de creatinina estimado <30 ml/min o uso de diálisis en los 7 días anteriores al día 1.
    •Tratamiento previo con BCV en algún momento o tratamiento intravenoso (IV) con cidofovir (CDV) en las 48 horas anteriores al día 1.
    •Tratamiento con alguna terapia celular contra el AdV en las 6 semanas
    anteriores al día 1 o tratamiento previo con una vacuna contra el AdV en
    algún momento.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the time-averaged area under the concentration-time curve (AAUC) for AdV viremia (log10 copies/mL) through Week 16 post-randomization.
    El criterio principal de valoración de la eficacia en este estudio es el área
    bajo la curva de concentración y tiempo promediado en el tiempo (AAUC) para la viremia por AdV (log10 copias/ml) desde la aleatorización hasta la semana 16 después de la aleatorización.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16 post-randomization.
    semana 16 después de la aleatorización
    E.5.2Secondary end point(s)
    • Time to all-cause mortality.
    • Incidence of and time to all-cause mortality.
    • Incidence of and time to non-relapse mortality.
    • Incidence of and time to AdV-associated mortality.
    • Proportion of subjects with ≥ 2-log10 decline from baseline or undetectable AdV viremia at Weeks 2, 4, 6, 12 and 16.
    •Tiempo hasta la mortalidad por todas las causas.
    •Incidencia y tiempo hasta la mortalidad por todas las causas.
    •Incidencia y tiempo hasta mortalidad no asociada a una recidiva.
    •Incidencia y tiempo hasta la mortalidad asociada al AdV.
    •Proporción de sujetos con una reducción ≥2-log10 desde el valor basal o una viremia por AdV indetectable en las semanas 2, 4, 6, 12 y 16
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy Endpoints: until Week 16
    Safety Endpoints: until Week 36
    Criterios de valoración de la eficacia: hasta la semana 16.
    Criterios de valoración de la seguridad: hasta la semana 36.
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Tratamiento habitual
    Standard of Care
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    France
    Germany
    Ireland
    Italy
    Netherlands
    Spain
    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 Last Subject
    Última Visita Último Paciente
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 141
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 28
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 85
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 28
    F.1.2Adults (18-64 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 91
    F.4.2.2In the whole clinical trial 141
    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)
    Responsibility lies with the treating physician. Depending on need this could be standard of care or no treatment. The investigator may apply for BCV through local NPP which may exceptionally be granted.
    La responsabilidad recae en el médico tratante. Según la necesidad, esto podría ser un tratamiento habitual o ningún tratamiento. El investigador puede solicitar el BCV a través de un PNP local que excepcionalmente puede otorgarse.
    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 Decision2018-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-05-30
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