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    Summary
    EudraCT Number:2010-018283-16
    Sponsor's Protocol Code Number:BHR-100-301
    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:2010-07-08
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2010-018283-16
    A.3Full title of the trial
    Estudio en Fase III, aleatorizado, doble ciego, controlado con placebo para investigar la eficacia y seguridad de Progesterona en pacientes con Traumatismo Craneoencefálico Severo
    A.4.1Sponsor's protocol code numberBHR-100-301
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBHR Pharma, LLC
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameBHR-100 (emulsión lipídica de progesterona intravenosa)
    D.3.2Product code BHR-100
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNprogesterona
    D.3.9.1CAS number 57-83-0
    D.3.9.3Other descriptive namePregn-4-ene-3,20-diona
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboIntravenous infusion
    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
    Traumatismo Craneoencefálico Severo
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level LLT
    E.1.2Classification code 10060690
    E.1.2Term Trauma cerebral
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo del estudio es determinar la eficacia y seguridad de la infusión intravenosa de progesterona BHR-100 en comparación con la infusión de placebo, utilizando la escala de Glasgow (GOS) en pacientes con Traumatismo Craneoencefálico Severo (GCS 4-8). El tratamiento se administra de forma continua durante 5 días comenzando dentro de las 8 horas posteriores al traumatismo. Además, se evaluará la seguridad y beneficio clínico del tratamiento con BHR-100 mediante las variables secundarias de eficacia.
    E.2.2Secondary objectives of the trial
    Además, el beneficio clínico del tratamiento con progesterona se valorará también mediante la evaluación de:

    1. La mortalidad 1 mes y 6 meses después del traumatismo.
    2. GOS a los 3 meses.
    3. GOS-E a los 3 y 6 meses.
    4. La Calidad de Vida usando el Cuestionario de Salud formulario corto (SF-36) a los 3 y 6 meses.
    5. El efecto de la Presión intracraneal (PIC), la Presión de perfusión cerebral (PPC) y el Nivel de intensidad terapéutica (NIT).
    6. El efecto sobre la progresión de la patología intracraneal mediante exploración por tomografía axial computerizada (TAC) en el ingreso y el día 6.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes de sexo masculino o femenino, de edades entre los 16 y los 70 años, inclusive (el límite inferior de edad se podrá ajustar de acuerdo a las normativas locales).
    2. Peso de 45 a 135 kg, inclusive.
    3. Que hayan sufrido un traumatismo craneal cerrado no más de 8 horas antes del inicio de la infusión del fármaco del estudio.
    4. TCE diagnosticado por historial y examen clínico.
    5. Puntuación GCS tras la reanimación entre 4 y 8, inclusive.
    6. Al menos una pupila reactiva.
    7. Evidencia de TCE confirmado por anomalías consistentes con traumatismo en la exploración por TAC realizada en el ingreso (Lesiones difusas tipos II-IV, lesión masa evacuada y no evacuada, Clasificación de Marshall).
    8. Indicación para monitorización de la PIC.
    E.4Principal exclusion criteria
    1. Esperanza de vida de menos de 24 horas, determinada por el Investigador.
    2. Hipoxia prolongada o incorregible (Pa02< 60 mmHg) o hipotensión (tensión arterial sistólica < 90 mmHg) en el momento del ingreso.
    3. Cualquier traumatismo de la columna vertebral.
    4. Embarazo.
    5. Herida craneal penetrante.
    6. Pupilas dilatadas y fijas bilateralmente en el momento de la aleatorización.
    7. Coma que, según se sospecha, se debe principalmente a otras causas (por ejemplo, alcohol).
    8. Hematoma epidural puro.
    9. Una enfermedad o afección crónica preexistente clínicamente significativa que se pueda determinar en el momento del ingreso y pueda afectar al resultado funcional.
    10. Inestabilidad hemodinámica o cardiaca grave tras la reanimación.
    11. Tratamiento conocido con otro fármaco o procedimiento en fase de investigación durante los 30 días previos al traumatismo.
    12. Antecedentes de reacción alérgica a la progesterona y fármacos relacionados o a cualquiera de los componentes de la infusión.
    13. Cualquier enfermedad que, en opinión del Investigador, no esté controlada o pudiera poner en peligro la seguridad del paciente y su cumplimiento del estudio.
    14. Sujetos que, en opinión del Investigador, no podrían o no estarían dispuestos a cumplir con el protocolo hasta la visita final (6 meses después del traumatismo).
    E.5 End points
    E.5.1Primary end point(s)
    Evaluación de la escala de Glsagow (GOS) en el Mes 6 después del traumatismo.
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 No
    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.8.3 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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA57
    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
    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
    Última visita del 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 months2
    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 months2
    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 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.1.3Elderly (>=65 years) Yes
    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
    Como los pacientes no podrán otorgar su consentimiento informado en la visita basal debido a su estado clínico, se obtendrá el consentimiento de un Representante Legal Autorizado (RLA) dentro de las 8 h posteriores al traumatismo.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 273
    F.4.2.2In the whole clinical trial 1180
    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)
    Según protocolo
    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 Decision2010-09-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
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