Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-022380-35
    Sponsor's Protocol Code Number:CIGMA982
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-15
    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 number2010-022380-35
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multicenter, parallel-group, adaptive group-sequential phase II study, to determine the efficacy and safety of BT086 as an adjunctive treatment in severe community acquired pneumonia (sCAP).
    Estudio de fase II, aleatorizado, doble ciego, controlado con placebo, multicéntrico, de grupos paralelos, adaptivo, secuencial en grupos, para determinar la eficacia y seguridad de BT086 como tratamiento complementario en casos de neumonía grave adquirida en la comunidad (sCAP).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, double-blind, placebo-controlled, multicenter, parallel-group, adaptive group-sequential phase II study, to determine the efficacy and safety of BT086 as an adjunctive treatment in severe pneumonia (sCAP) acquired outside the hospital.
    Estudio de fase II, aleatorizado, doble ciego, controlado con placebo, multicéntrico, de grupos paralelos, adaptivo, secuencial en grupos, para determinar la eficacia y seguridad de BT086 como tratamiento complementario en casos de neumonía grave (sCAP) adquirida fuera del hospital .
    A.3.2Name or abbreviated title of the trial where available
    BT086-sCAP
    A.4.1Sponsor's protocol code numberCIGMA982
    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 SponsorBiotest AG
    B.1.3.4CountryGermany
    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 supportBiotest AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSalutis Research S.L.
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de Gràcia 46, Ático
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08007
    B.5.3.4CountrySpain
    B.5.4Telephone number+34932412976
    B.5.5Fax number+34932412977
    B.5.6E-mailmariajesus.marlasca@salutis-research.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 nameIgM Concentrado
    D.3.2Product code BT086
    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 INNIgM Concentrate
    D.3.9.1CAS number 0
    D.3.9.2Current sponsor codeBT086
    D.3.9.3Other descriptive nameInmunoglobulina Humana Normal (IV)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) Yes
    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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    severe Community Acquired Pneumonia (sCAP)
    Neumonía grave adquirida en la comunidad (sCAP)
    E.1.1.1Medical condition in easily understood language
    severe Pneumonia (sCAP) acquired outside the hospital
    Neumonía grave (sCAP) adquirida fuera del hospital
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10010120
    E.1.2Term Community acquired pneumonia
    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
    Evaluate the efficacy (ventilator free days) of BT086 IgM concentrate in patients with sCAP (severe community acquired pneumonia)
    Evaluar la eficacia (días sin ventilación endotraqueal) de BT086, concentrado de IgM en pacientes con neumonía grave adquirida en la comunidad.
    E.2.2Secondary objectives of the trial
    Demostrate repeated dose safety, tolerability and pharmacokinetics of BT086 intravenous administration.
    Pharmacokinetics: evaluation of IgM and serum concentration of IgM, IgA, IgG in approximately 20 patients.
    Evaluation of safety and tolerability in term of:
    - Infusion-related reactions
    - Adverse events (AEs)
    - Vital Signs
    - Electrocardiogram (ECG)
    - Safety laboratory
    Demostrar la seguridad, tolerabilidad y farmacocinética de la administración intravenosa de BT086 en dosis repetidas.
    Farmacocinética: evaluación de IgM y concentración en suero de IgM, IgA e IgG en 20 pacientes aproximadamente.
    Evaluar la seguridad y tolerabilidad de acuerdo a:
    - reacciones relacionadas con al infusión
    - eventos adversos (AE)
    - signos vitales
    - electrocardiograma (ECG)
    - laboratorio de seguridad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Consentimiento informado por escrito:
    otorgado por el paciente
    o
    un representante legal/autorizado del paciente
    o
    una renuncia al consentimiento informado por escrito debido a una situación de emergencia, que cumple todos los requisitos legales del lugar.
    2. Pacientes masculinos o femeninos de 18 años de edad o mayores
    3. El paciente recibe un tratamiento adecuado de la neumonía con antibióticos
    4. Antes de la terapia y la respiración endotraqueal, el paciente debe demostrar por lo menos uno de los dos síntomas de inflamación siguientes.
    Fiebre/Hipotermia
    Fiebre se define como una temperatura oral superior a 38° C, temperatura timpánica superior a >38° C o temperatura rectal superior a 38,5° C, o hipotermia (temperatura rectal inferior a 35,5° C)
    o
    Recuento de glóbulos blancos (WBC por sus siglas en inglés) superior a 10.000/mm³ o glóbulos blancos inferiores a 4.500/mm³
    5. El paciente debe demostrar por lo menos uno de los siguientes indicadores y síntomas de la neumonía:
    Aumento o aparición de la tos
    Expectoración de materia mucopurulenta o cambio en sus características
    Disnea o taquipnea (frecuencia respiratoria superior a 20 respiraciones por minuto)
    Dolor pleurítico en el pecho
    Determinación por auscultación durante la evaluación pulmonar de ruidos o crepitación o evidencia de consolidación pulmonar (o sea, matidez al percutir,
    sonidos de respiración bronquial o egofonía)
    6. Evidencia radiológica (o de otra técnica de imágenes) de (un) infiltrado(s) consistente(s) con neumonía bacteriana.
    7. La neumonía se contrajo fuera del hospital. En pacientes admitidos al hospital, la neumonía se diagnosticó un máximo de 72 horas luego de la admisión. Los pacientes de hogares de ancianos o instituciones similares pueden participar.
    8. Criterio mayor de la neumonía grave adquirida en la comunidad: necesidad de ventilación endotraqueal.
    9. El tratamiento del paciente con BT086 debe comenzar dentro de las 12 horas pero no antes de 1 hora luego del comienzo de la ventilación endotraqueal.
    E.4Principal exclusion criteria
    1. En pacientes impedidos: cualquier indicación de que la supuesta voluntad del paciente estaría en contra de su inclusión en el estudio.
    2. Pacientes con neumonía que se sospecha fue contraída en el hospital.
    3. Enfermedades pulmonares severas que interfieren con la terapia de la neumonía grave adquirida en la comunidad, por ejemplo, pacientes con fibrosis quística.
    4. No pueden participar en el estudio pacientes que reciben Xigris® (drotrecogina alfa, Proteína C activada) o medicamentos no aprobados para el tratamiento de la neumonía grave adquirida en la comunidad (por ejemplo, dornasa alfa).
    5. Pacientes que reciben diálisis.
    6. Presencia de otras enfermedades severas que afecten la expectativa de vida (por ejemplo, pacientes que no se espera puedan sobrevivir 28 días dada una enfermedad médica incorregible preexistente).
    7. Pacientes que no puedan ser tratados debido a la obesidad.
    8. Deficiencia selectiva y absoluta de IgA con anticuerpos detectados del IgA.
    9. Pacientes con un recuento de neutrófilos inferior a 1.000/mm³ o recuento de plaquetas inferior a 50.000/mm³.
    10. Mujeres embarazadas o que den el pecho. Se realizará un análisis para determinar si están embarazadas a todas las mujeres menores de 65 años de edad y el resultado debe estar disponible para incluirse en el estudio.
    11. Intolerancia conocida relevante a inmunoglobulinas, vacunas u otras sustancias de origen humano.
    12. Participación en otro estudio clínico con intervención en los 30 días antes de ingresar al estudio o durante el estudio, o participación previa en este estudio (se permite la participación en estudios observacionales).
    E.5 End points
    E.5.1Primary end point(s)
    El objetivo primario es el aumento en los días sin ventilación endotraqueal (VFD por sus siglas en inglés) calculados en pacientes con neumonía grave adquirida en la comunidad tratados complementariamente con BT086 y el tratamiento apropiado comparado con pacientes tratados con placebo y el tratamiento apropiado.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Dentro de los 28 días
    E.5.2Secondary end point(s)
    · Días sin respiración endotraqueal en los pacientes supervivientes.
    · Mortalidad por todas las causas a los 28 días.
    · Mortalidad causada por la neumonía a los 28 días.
    · Tiempo hasta el alta de la UCI.
    · Tiempo hasta el alta del hospital.
    · Puntuaciones SOFA.
    · Días sin vasopresores.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Dentro de los 28 días
    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 Yes
    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 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 Yes
    E.8.1.7.1Other trial design description
    grupo secuencial adaptativo
    adaptive group-sequential
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 last subject (chapter 13.2 of the study protocol)
    Última visita del último paciente (ver capítulo 13.2 del protocolo).
    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 months0
    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 months0
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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: 42
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Unconscious due to mechanical ventilation.
    Inconsciente debido a la ventilación mecánica.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state56
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 82
    F.4.2.2In the whole clinical trial 82
    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 Decision2011-08-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-15
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri Apr 19 13:19:33 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA