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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   43876   clinical trials with a EudraCT protocol, of which   7294   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:2022-000763-45
    Sponsor's Protocol Code Number:P-105-401
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2022-07-27
    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 number2022-000763-45
    A.3Full title of the trial
    Global Registry for Long-Term Follow-up of Patients Participating in Clinical Trials with Posoleucel (ALVR105)
    Registro mundial para el seguimiento a largo plazo de pacientes que participan en ensayos clínicos con posoleucel (ALVR105)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Global Registry for Long-Term Follow-up of Patients Participating in Clinical Trials with Posoleucel (ALVR105)
    Registro mundial para el seguimiento a largo plazo de pacientes que participan en ensayos clínicos con posoleucel (ALVR105)
    A.4.1Sponsor's protocol code numberP-105-401
    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 SponsorAlloVir, 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 supportAlloVir, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAlloVir, Inc.
    B.5.2Functional name of contact pointClinical Trials Information Line
    B.5.3 Address:
    B.5.3.1Street AddressKirby Grove, 2925 Richmond Avenue, Suite 1200
    B.5.3.2Town/ cityHouston, Texas
    B.5.3.3Post codeTX 77098
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 (833) 409-2281
    B.5.6E-mailclinicaltrials@allovir.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/3/20/2260
    D.3 Description of the IMP
    D.3.1Product namePosoleucel
    D.3.2Product code ALVR105
    D.3.4Pharmaceutical form Dispersion 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 INNPosoleucel
    D.3.9.1CAS number Posoleucel
    D.3.9.2Current sponsor codeALVR105
    D.3.9.3Other descriptive nameALVR105
    D.3.9.4EV Substance CodeSUB197084
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number00000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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
    Adenovirus (AdV), BK virus (BKV), John Cunningham virus (JCV), human herpesvirus 6 (HHV- 6), Epstein-Barr virus (EBV), and cytomegalovirus
    (CMV) infections and/or disease in patients at high risk for these viruses following allogeneic hematopoietic cell transplant (HCT) or solid organ transplant (SOT).
    Adenovirus (AdV), virus BK (VBK),virus John Cunningham (VJC),virus del herpes humano 6 (VHH-6); virus de Epstein-Barr (VEB) y citomegalovirus (CMV), infecciones y/o enfermedades en pacientes con alto riesgo de contraer estos virus tras un trasplante de progenitores hematopoyéticos (TPH) o un trasplante de órganos sólidos (TOS).
    E.1.1.1Medical condition in easily understood language
    AdV, BKV, JCV, HHV- 6, EBV, and CMV infections and/or disease in patients at high risk for these viruses following allogeneic hematopoietic cell transplant or solid organ transplant.
    AdV VBK VJC VHH-6 VEBCMV infecciones y/o enfermedades en pacientes con alto riesgo de contraer estos virus tras un trasplante alogénico de células hematopoyéticas o un trasplante de órganos sólido.
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10055181
    E.1.2Term BK virus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10023163
    E.1.2Term JC virus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level PT
    E.1.2Classification code 10020431
    E.1.2Term Human herpesvirus 6 infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10015108
    E.1.2Term Epstein-Barr virus infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long-term safety of Posoleucel (PSL).
    Evaluar la seguridad a largo plazo de PSL.
    E.2.2Secondary objectives of the trial
    To evaluate the long-term effectiveness of PSL.
    To evaluate rates of overall mortality and non-relapse mortality.
    Evaluar la efectividad a largo plazo de PSL.
    Evaluar los índices de mortalidad global y mortalidad sin recaída.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participation in an Allovir-sponsored PSL clinical trial, regardless of treatment assignment (PSL or placebo) and completion status (completion, early discontinuation).
    2. Patient received at least one infusion of PSL or placebo.
    3. Patient is willing and able to provide written informed consent to participate in the registry, or a parent or legal guardian is willing and able to provide written informed consent and the potential paediatric participant is able to provide assent in a manner approved by the Institutional Review Board/Independent Ethics Committee and local regulations.
    1.Participación en un ensayo clínico con PSL promovido por Allovir, independientemente de la asignación del tratamiento (PSL o placebo) y el estado de finalización (finalizado o retirada prematura).
    2.Pacientes que hayan recibido al menos una infusión de PSL o placebo.
    3.Pacientes que puedan y deseen proporcionar su consentimiento informado por escrito para participar en el registro o para los que un progenitor o tutor legal que pueda y desee proporcionar dicho consentimiento informado por escrito. Los posibles participantes pediátricos deberán poder proporcionar su asentimiento de una forma aprobada por el comité de ética y la legislación local.
    E.4Principal exclusion criteria
    None
    Ninguno.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of adverse drug reactions (ADRs) related to PSL.
    Incidencia de reacciones adversas al medicamento (RAM) relacionadas con el PSL.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Enrolment visit, Follow up.
    Visita de enrolamiento, seguimiento.
    E.5.2Secondary end point(s)
    1. Incidence of clinical infection with viruses targeted by PSL.
    2. Overall mortality.
    3. Non-relapse mortality (defined as death without recurrent or progressive disease after transplantation).
    1.Incidencia de infección clínica por virus a los que va dirigido PSL.
    2.Mortalidad global.
    3.Mortalidad sin recaída (definida como muerte sin recidiva de la enfermedad o progresión tras el trasplante)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Enrolment visit, Follow up.
    2. Follow-up.
    3. Follow-up.
    1. Visita de enrolamiento, seguimiento.
    2. Seguimiento.
    3. Seguimiento.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Health economic resource utilization
    Recurso de utililización economía de la salud.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    Registro mundial para el seguimiento a largo plazo de pacientes que participan en ensayos clínicos c
    Global Registry for Long-Term Follow-up of Patients Participating in Clinical Trials with Posoleucel
    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.8.2.4Number of treatment arms in the trial0
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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
    Canada
    Korea, Republic of
    United States
    France
    Sweden
    Spain
    Italy
    Belgium
    United Kingdom
    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
    Ultima visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days10
    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: 145
    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: 20
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 50
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 75
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 105
    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
    Pediatric patients
    Pacientes pediátricos
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 159
    F.4.2.2In the whole clinical trial 500
    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
    Ninguno
    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 Decision2022-09-08
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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