Kliniska prövningar Nct sida

Summary
EudraCT Number:2006-000679-14
Sponsor's Protocol Code Number:Mio/Reg/percutáneo/Aleatorizado
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:2006-06-29
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
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2006-000679-14
A.3Full title of the trial
ESTUDIO DE FASE II CIEGO, CONTROLADO Y ALEATORIZADO DE EFICACIA DEL IMPLANTE PERCUTÁNEO DE MIOBLASTOS AUTÓLOGOS EN PACIENTES CON INFARTO ANTIGUO. (STUDY PHASE II BLINDED, CONTROLATED AND RANDOMIZED TO DETERMINE THE EFFECACY OF THE PERCUTANEOUS IMPLANT OF AUTOLOGOUS MYOBLAST IN PATIENS WITH OLD MYOCARDIAL INFARCT)
A.4.1Sponsor's protocol code numberMio/Reg/percutáneo/Aleatorizado
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 SponsorINSTITUTO CIENTÍFICO Y TECNOLÓGICO (ICT )DE NAVARRA, S.A.
B.1.3.4CountrySpain
B.3.1 and B.3.2Status of the sponsorNon-Commercial
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 nameSuspension of autologous skeletal myoblasts
D.3.4Pharmaceutical form Suspension for injection
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPIntracardiac use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNMIOBLASTOS AUTÓLOGOS
D.3.10 Strength
D.3.10.2Concentration typenot less then
D.3.10.3Concentration number100 X10^6
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) Information not present in EudraCT
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 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 placeboSolution for injection
D.8.4Route of administration of the placeboIntracardiac use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
PACIENTES CON INFARTO ANTIGUO DE MIOCARDIO (PATIENTS WITH OLD MYOCARDIAL INFARCT)
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 6.1
E.1.2Level PT
E.1.2Classification code 10052475
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
COMPARAR LA MEJORÍA DE LA FUNCIÓN CARDIACA GLOBAL Y REGIONAL MEDIDA POR ECOCARDIOGRAFÍA (TAMBIÉN SE ANALIZARÁ POR CRM, AUNQUE EL OBJETIVO PRINCIPAL SE DETERMINARÁ EN FUNCIÓN DE LOS PARÁMETROS ECOCARDIOGRÁFICOS) EN PACIENTES CON INFARTO DE MIOCARDIO CRÓNICO Y SIN SIGNOS DE VIABILIDAD, SOMETIDOS O NO A LA ADMINISTRACIÓN ENDOCAVITARIA POR VÍA PERCUTÁNEA DE MIOBLASTOS AUTÓLOGOS.
E.2.2Secondary objectives of the trial
- COMPARAR EL EFECTO SOBRE LA VIABILIDAD MEDIDA POR RM EN PACIENTES CON IM ANTIGUO SOMETIDOS O NO A ADMINISTRACIÓN PERCUTÁNEA DE MIOBLASTOS AUTÓLOGOS.

- COMPARAR LA INCIDENCIA DE EFECTOS ADVERSOS, SOBRE TODO ARRITMIAS VENTRICULARES, MEDIANTE LA REALIZACIÓN SERIADA DE HOLTER ELECTROCARDIOGRÁFICO DE 24 HORAS, O BIEN MEDIANTE LA IMPLANTACIÓN DE UN HOLTER IMPLANTABLE SUBCUTÁNEO.

- COMPARAR LA MORTALIDAD A LARGO PLAZO.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
- PACIENTES CON DIAGNÓSTICO DE INFARTO DE MIOCARDIO, AUSENCIA DE VIABILIDAD DEMOSTRADA MEDIANTE ECOCARDIOGRAFÍA CON DOBUTAMINA A DOSIS BAJAS Y ACINESIA O DISCINESIA.

- FRACCIÓN DE EYECCIÓN MAYOR DEL 0.25 Y MENOR DEL 0.50.

- EDAD ENTRE 30 Y 80 AÑOS.

- TEST DE EMBARAZO NEGATIVO (EN CASO DE MUJERES EN EDAD FERTIL).

- OTORGAR SU CONSENTIMIENTO INFORMADO ANTE TESTIGO POR ESCRITO, DE ACUERDO CON LA NORMATIVA LEGAL VIGENTE.
E.4Principal exclusion criteria
- HISTORIA PREVIA DE TAQUICARDIA O FIBRILACIÓN VENTRICULAR (SALVO EN LA FASE AGUDA DEL IM).

- REVASCULARIZACIÓN DE LA ARTERIA RESPONSABLE DEL INFARTO DE MENOS DE SEIS MESES DE EVOLUCION.

- INFARTO DE MIOCARDIO DE MAS DE 10 AÑOS DE EVOLUCIÓN.

- PACIENTES CON SEROLOGÍA VIH, VHB, VHC POSITIVA.

- PACIENTES CON ALTERACIÓN FUNCIONAL DE ORGANOS: FUNCIÓN HEPÁTICA: BILIRRUBINA TOTAL, AST, ALT Y FOSFATASA ALCALINA SUPERIOR A 2 VECES EL LÍMITE SUPERIOR DEL RANGO NORMAL DEL LABORATORIO; FUNCIÓN RENAL: CREATININA SERICA >1.5 MG/DL O ACLARAMIENTO DE CREATININA >50 ML/MIN. EN EL CASO DE QUE LAS ALTERACIONES SEAN SECUNDARIAS A LA ENFERMEDAD QUEDA A CRITERIO DEL INVESTIGADOR DETERMINAR SI EL PACIENTE PUEDE SER INCLUIDO EN EL ENSAYO.

- HISTORIA DE NEOPLASIA ACTIVA O TRATAMIENTO PREVIO CON QUIMIOTERAPIA.

- EL PACIENTE NO DEBE PADECER UNA ENFERMEDAD MEDICA CONCOMITANTE GRAVE Y/O NO CONTROLADA (P.EJ. INSUFICIENCIA RENAL CRÓNICA O HEPÁTICA MAL CONTROLADA, HIPERTENSIÓN ARTERIAL MAL CONTROLADA).

- PACIENTES QUE DEBIDO A SU SITUACIÓN GEOGRAFICA, PSIQUIÁTRICA O SOCIAL, TENGAN DIFICULTAD EN CUMPLIR LAS CONDICIONES DEL PROTOCOLO.

- MUJERES EMBARAZADAS O EN PERIODO DE LACTANCIA.
E.5 End points
E.5.1Primary end point(s)
FUNCIÓN GLOBAL Y REGIONAL MEDIDA MEDIANTE ECOCARDIOGRAFÍA Y RM
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 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 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 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 Yes
E.8.4 The trial involves multiple sites in the Member State concerned No
E.8.5The trial involves multiple Member States No
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 Information not present in EudraCT
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
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years3
E.8.9.1In the Member State concerned months
E.8.9.1In the Member State concerned days
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
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) No
F.1.1.6Adolescents (12-17 years) No
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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-06-29. Yes
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 No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state50
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 Decision2006-11-22
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2006-04-11
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2012-06-19

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