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    Summary
    EudraCT Number:2013-002986-21
    Sponsor's Protocol Code Number:MST-188-01
    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:2014-07-21
    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 number2013-002986-21
    A.3Full title of the trial
    Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial of MST-188 (purified poloxamer 188) Injection in Subjects with Sickle Cell Disease Experiencing Vaso-Occlusive Crisis
    Evaluación de poloxámero purificado 188 en crisis vaso-oclusiva por drepanocitosis (EPIC): Un estudio clínico de la inyección MST-188 (poloxámero purificado 188), Fase 3, aleatorizado, doble ciego, controlado con placebo y multicéntrico, en sujetos con drepanocitosis que experimentan crisis vaso-oclusiva.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of Purified Poloxamer 188 in Subjects with Sickle Cell Disease Experiencing a Vaso-occlusive Crisis
    Evaluación de poloxámero 188 purificado en sujetos con anemia en sujetos con anemia de células falciformes que experimentan una crisis vaso-oclusiva
    A.3.2Name or abbreviated title of the trial where available
    Evaluation of Purified Poloxamer 188 in Subjects in Crisis (EPIC)
    Evaluación de poloxámero 188 purificado en sujetos en crisis (EPIC)
    A.4.1Sponsor's protocol code numberMST-188-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01737814
    A.5.4Other Identifiers
    Name:IND NumberNumber:31,246
    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 SponsorMast Therapeutics, 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 supportMast Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharm-Olam International (Spain), S.L.U.
    B.5.2Functional name of contact pointRegulatory Department
    B.5.3 Address:
    B.5.3.1Street AddressCalle Antracita, 7 , 1ª Planta, Nave 6
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28045
    B.5.3.4CountrySpain
    B.5.4Telephone number34911459110
    B.5.5Fax number34914342773
    B.5.6E-mailregulatory.spain@pharm-olam.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/3/13/1112
    D.3 Description of the IMP
    D.3.1Product nameMST-188 (purified poloxamer 188) Injection
    D.3.2Product code MST-188
    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 INNPurified poloxamer 188
    D.3.9.1CAS number 9003-11-6
    D.3.9.2Current sponsor codePurified poloxamer 188
    D.3.9.4EV Substance CodeSUB16038MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for 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
    Sickle Cell Disease with Vaso-Occlusive Crisis
    Enfermedad de las células falciformes con crisis vaso-oclusiva.
    E.1.1.1Medical condition in easily understood language
    Sickle Cell Disease in hospitalized subjects Experiencing a Vaso-Occlusive Crisis
    Enfermedad de las células falciformes en sujetos hospitalizados que experimentan crisis vaso-oclusiva
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10040644
    E.1.2Term Sickle cell disease
    E.1.2System Organ Class 100000004850
    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 is to demostrate the efficacy of MST-188 in reducing the duration of vaso-occlusive crisis (VOC) in subjects with sickle cell disease (SCD). The duration of VOC will be measured from the time of randomization to the time at which a subject receives the last dose of parenteral opioid analgesia for the treatment of VOC prior to hospital discharge.
    El objetivo principal es demostrar la eficacia de MST-188 para reducir la duración de la crisis vaso-oclusiva (CVO) en sujetos con drepanocitosis (o ECF, enfermedad de las células falciformes). La duración de CVO se medirá a partir del momento de la aleatorización hasta el momento en que el sujeto reciba la última dosis de analgesia opioide parenteral para el tratamiento de CVO antes del alta hospitalaria.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    o To compare the re-hospitalization rate (for VOC) between the treatment arms.
    o To compare the occurrence of acute chest syndrome (ACS) between the treatment arms.
    Los objetivos secundarios son:
    o Comparar el índice de reingreso al hospital (debido a CVO) entre los grupos de tratamiento.
    o Comparar la co-ocurrencia del síndrome torácico agudo (STA) entre los grupos de tratamiento.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The subestudies Pharmacodynamic laboratory biomarkers will be evaluated in a sub-study to this trial.
    The effects of tissue oxygen saturation will be evaluated in a sub-study to this trial. These sub-studies will only be conducted in United States.
    Los sub-estudios de Farmacodinámica y biomarcadores de laboratorio se evaluarán en un sub-estudio en este ensayo clínico.
    Los efectos de saturación de oxígeno en el flujo sanguíneo serán evaluados en un sub-estudio de este ensayo. Estos subestudios solo se llevará a cabo en Estados Unidos de Norteamérica.
    E.3Principal inclusion criteria
    1. Written documentation of informed consent and assent as applicable. Note: Minors must provide assent to participate in this study at an age-appropriate level determined and approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) for the study center.
    2. Subject is ?4 and ?65 years of age.
    3. Subject has confirmed diagnosis of HbSS, HbSC, HbS?+thal, or HbS?0thal.
    4. Subject is experiencing acute pain typical of VOC and requires treatment with parenteral opioid analgesia.
    5. Subject has been in moderate to severe pain as a result of the current VOC for no more than 24 hours at the time of presentation to the study center and for at least 4 hours prior to randomization.
    6. Subject is hospitalized or in the process of admission for VOC at time of randomization.
    7. If the subject is taking hydroxyurea, the dose is expected to remain stable through discharge.
    8. If sexually active, the subject agrees to use reliable contraception while participating in this study and for at least 30 days after discontinuation of blinded study drug infusion.
    9. If the subject is female and of child-bearing potential, must have negative pregnancy test (urine or serum).
    1. Documentación por escrito del consentimiento informado y asentimiento, según corresponda. Nota: menores deben dar su asentimiento para participar en el estudio, de acuerdo con un nivel
    adecuado a su edad, el cual determina y aprueba el Comité de Ética de Investigación Clínica (CEIC) del centro en que se lleva a cabo el estudio.
    2. Sujeto de ?4 y ?65 años de edad.
    3. Sujeto con diagnóstico confirmado de HbSS, HbSC, HbS? +tal o HbS?0tal.
    4. Sujeto con dolor agudo típico de CVO que requiere tratamiento con analgésicos opioides parenterales.
    5. Sujeto con dolor de moderado a severo debido a la CVO actual no mayor a 24 horas al momento de presentarse en el centro que se realiza el estudio y al menos 4 horas antes de la aleatorización.
    6. Sujeto hospitalizado o en proceso de admisión debido a CVO al momento de hacer la aleatorización.
    7. Si el sujeto está tomando hidroxiurea, se espera que permanezca estable hasta el alta.
    8. Si es sexualmente activo, el sujeto está de acuerdo en usar un método anticonceptivo confiable mientras participa en el estudio y durante por lo menos 30 días después de haber interrumpido la infusión del fármaco de estudio ciego.
    9. Si el sujeto es mujer con posibilidades de embarazo, debe haber dado negativo en una prueba de embarazo (orina o sangre).
    E.4Principal exclusion criteria
    1. Subject has suspected ACS, including either:
    a) baseline chest X-ray indicating a new pulmonary infiltrate or
    b) subject has acute respiratory symptoms consistent with ACS or with acute asthma attack.
    2. Subject has platelet count <80,000/mm3.
    3. Subject has a known or suspected bleeding disorder.
    4. Subject has inadequate liver function defined as ALT >3X the institution?s upper limit of normal.
    5. Subject has the following serum creatinine value:
    ? Age ?4-7 years: >0.8 mg/dL (>70.7 ?mol/L)
    ? Age ?8-13 years: >0.9 mg/dL (>79.6 ?mol/L)
    ? Age ?14 years: >1.0 mg/dL (>88.4 ?mol/L)
    6. Subject is pregnant or nursing.
    7. Subject has had an episode of painful crisis requiring hospitalization within the preceding 14 days.
    8. Subject has been transfused within the past 14 days.
    9. Subject is already hospitalized for any condition other than the current VOC.
    10. Subject uses opioid analgesia on a daily basis for any reason.
    11. Subject is currently receiving another investigational drug or has received any investigational drug within 30 days prior to randomization.
    12. Subject presents with complications related to SCD, such as: aplastic crisis, priapism, sepsis, stroke, hepatic or splenic sequestration, or any complication expected to require surgical intervention.
    13. Subject has experienced >5 hospitalizations for VOC in the prior 6 months.
    14. Investigator believes subject is suffering from chronic pain (e.g., necrotic tissue resulting from repeated prior VOCs) and not acute pain associated with an ongoing VOC.
    15. Subject is otherwise not an appropriate study candidate, in the Investigator's judgment.
    16. Subject has been previously enrolled in the present trial or any prior MST-188 clinical trial.
    1. El sujeto tiene sospecha de STA, incluyendo cualquiera de las siguientes características:
    a) radiografía de tórax inicial que indica una infiltración pulmonar o
    b) el sujeto presenta síntomas respiratorios agudos que corresponden a STA o con ataque agudo de asma.
    2. El sujeto presenta un conteo de plaquetas de <80,000/mm3.
    3. El sujeto presenta algún trastorno hemorrágico confirmado o se sospecha de ello.
    4. El sujeto presenta funcionamiento inadecuado del hígado, definido como ALT >3veces, lo cual es el límite normal más alto para la institución.
    5. El sujeto presenta los siguientes valores de creatinina sérica:
    ? En ?4-7 años de edad >0.8 mg/dl (>70.7 ?mol/l)
    ? En ?8-13 años de edad >0.9 mg/dl (>79.6 ?mol/l)
    ? En ?14 años de edad >1.0 mg/dl (>88.4 ?mol/l)
    6. El sujeto está en embarazo o lactancia.
    7. El sujeto ha tenido un episodio de crisis dolorosa que requirió hospitalización en los últimos 14 días.
    8. El sujeto ha recibido una transfusión en los últimos 14 días
    9. El sujeto ya está hospitalizado por cualquier otra condición diferente del padecimiento actual de CVO.
    10. El sujeto toma analgésicos opioides diariamente por cualquier razón.
    11. El sujeto actualmente recibe otro fármaco de investigación o lo ha recibido en los últimos 30 días antes de la aleatorización.
    12. El sujeto presenta complicaciones relacionadas con ECF, como: crisis aplástica, priapismo, sepsis,apoplejía, secuestro hepático o esplénico o cualquier otra complicación en la que se prevé
    intervención quirúrgica.
    13. El sujeto ha sido hospitalizado más de 5 veces debido a CVO en los últimos 6 meses.
    14. El investigador sospecha que el sujeto sufre de dolor crónico (es decir, tejido necrótico resultado de las repetidas CVO anteriores) y ningún dolor agudo se asocia con la CVO en curso.
    15. El sujeto no es un candidato adecuado para el estudio a juicio del investigador.
    16. El sujeto ya ha estado antes en este estudio o algún otro ensayo clínico de MST-188.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the time from randomization to last parenteral opioid analgesic dose for the treatment of VOC prior to hospital discharge.
    El criterio de valoración primario es el tiempo en horas desde la aleatorización hasta la última dosis antes del alta de analgésico opioide parental para tratar CVO.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time from randomization to last parenteral opioid analgesic dose for the treatment of VOC prior to hospital discharge.
    El tiempo en horas desde la aleatorización hasta la última dosis antes del alta de analgésico opioide parental para tratar CVO.
    E.5.2Secondary end point(s)
    Secondary Endpoints
    1. Re-hospitalization for VOC: The number and percent of subjects who are re-hospitalized for VOC within 14 days after discharge from the hospital.
    2. Occurrence of ACS: The number and percent of subjects who meet the protocol definition of ACS within 120 hours of randomization.
    1-Reingreso al hospital debido a CVO: se comparará entre los dos grupos de tratamiento el porcentaje de sujetos que regresan al hospital debido a CVO dentro de los 14 días después de haber sido dados de alta.
    2-Co-ocurrencia de STA: se compara entre los dos grupos de tratamiento el porcentaje de sujetos que entran dentro de la definición del protocolo de STA a las 120 horas de haberse hecho la aleatorización.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Within 14 days after discharge from the hospital.
    2. Within 120 hours of randomization
    1-Dentro de los 14 días después de haber sido dados de alta.
    2- A las 120 horas de haberse hecho la aleatorización.
    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) 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.8.2.4Number of treatment arms in the trial2
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Belgium
    Brazil
    Dominican Republic
    Lebanon
    Netherlands
    Oman
    Panama
    Saudi Arabia
    Spain
    Turkey
    United Kingdom
    United States
    Jordan
    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
    LVLS: 30-day post-hospitalization contact: Last subject will be queried regarding re-hospitalization for VOC 30 days (±2 days) following discharge. If this date is within 2 days of the 30-Day Post-Infusion Follow-up visit, the visits may be combined.
    UVUS: Contacto a los 30 días posteriores a la hospitalización: el último sujeto será contactado en relación con la re-hospitalización debido a una CVO recurrente a los 30(+/-2 días)después de que se le diera el alta. Si el contacto a los 30 días después de la hosp sucede a los 2 días de la consulta de control a la que se asiste 30 días desp de la infusión, deberá tomarse toda la info del sujeto corresp a estas 2 ocasiones durante la consulta de control a los 30 días después de la infusión.
    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 months10
    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 months7
    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 Yes
    F.1.1Number of subjects for this age range: 232
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 135
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 97
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 155
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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
    Minors must provide assent to participate in this study at an age-appropriate level determined and approved by the Institutional Review Board(IRB)/Independent Ethics Committee (IEC) for the study center.
    Los menores de edad deben prestar su asentimiento para participar en este EC en un nivel apropiado para su edad, determinado y aprobado por Comité Ético de Investigación Clínica (de Referencia CEIC) del ensayo.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 388
    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)
    Subjects completing this study may be eligible to participate in an open-label extension study to evaluate the safety of repeat exposures of MST-188 in VOC. A separate protocol is being contemplated based on understandings gained during the course of this study, input from experts and approval of appropriate ethics committees and regulatory bodies.
    Los sujetos que completen este estudio podrán ser elegibles para una extensión abierta de éste, con el
    objetivo de evaluar qué tan seguro es repetir la exposición a MST-188 cuando se presenta CVO. Se está
    considerando un segundo protocolo con base en la información que se obtenga del presente, en los
    comentarios de los expertos y en la aprobación de los respectivos comités de ética y de las instituciones
    que regulan la actividad.
    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 Decision2014-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-05
    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.

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