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    Summary
    EudraCT Number:2011-004820-37
    Sponsor's Protocol Code Number:PRGF/AF/2011
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-02-15
    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 number2011-004820-37
    A.3Full title of the trial
    Phase II, open-label clinical trial to evaluate the safety and efficacy of platelet-rich plasma and fibrin clot processed with PRGF-System tecnology in the treatment of anal fistulas in Crohn's patients
    Ensayo clínico fase II, abierto para evaluar la seguridad y factibilidad del plasma rico plaquetas y coagulo de fibrina procesados con la tecnologia PRGF-System, en el tratamiento de fístulas anales de enfermos con Crohn
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Experimental study in humans to evaluate the efficacy and safety of blood
    products rich in proteins for the treatment of anal fistulas in Crohn's
    patients
    Estudio de investigación en humanos para evaluar la eficacia y seguridad
    de derivados sanguineos ricos en proteínas para el tratamiento de fistulas
    anales en pacientes con enfermedad de Crohn
    A.4.1Sponsor's protocol code numberPRGF/AF/2011
    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 SponsorFundación FISEVI
    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 supportConsejería de Salud (Junta de Andalucía)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCICEC-Hospital Virgen del Rocío
    B.5.2Functional name of contact pointClara M. Rosso Fernández
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Manuel Siurot s/n
    B.5.3.2Town/ citySeville
    B.5.3.3Post code41013
    B.5.3.4CountrySpain
    B.5.4Telephone number34955013414
    B.5.5Fax number34954232992
    B.5.6E-mailclaram.rosso.sspa@juntadeandalucia.es
    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 namePlasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI)
    D.3.4Pharmaceutical form Rectal solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    Rectal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPlasma rico en plaquetas y coagulo de fibrina procesados mediante la tecnología PRGF-System (BTI)
    D.3.9.3Other descriptive nameHUMAN PLASMA FOR FRACTIONATION
    D.3.9.4EV Substance CodeSUB12043MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Perianal fistulas in Crohn's Disease Patients
    Fístulas perianales en enfermos de Crohn
    E.1.1.1Medical condition in easily understood language
    Lesions (fistulas) around the annus in patients with chronic inflamatory
    bowel disease (Crohn)
    Heridas (fistulas) alrededor del ano en pacientes con enfermedad
    crónica inflamatoria del intestino (Crohn)
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10068659
    E.1.2Term Perianal fistula
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Main objective: To evaluate the safety and feasibility of intralesional
    platelet-rich plasma and fibrin clot from autologous origin, processed with PRGF-System tecnology (BTI), for the treatment of perianal fistulas in Crohn's disease.
    Objetivo principal: Evaluar la seguridad y factibilidad de la terapia de la
    enfermedad fistulosa perianal en enfermos de Crohn mediante de plasma
    rico en plaquetas y coagulo de fibrina de origen autólogo procesado mediante la tecnología PRGF-System (BTI)
    E.2.2Secondary objectives of the trial
    Secondary objectives: To evaluate the efficacy in terms of ratio of
    complex perianal fistula closure, decrease in the number of draining
    fistulas after two consecutive visits, and
    percentage of subjects with healed fistula (measured by MRI).
    Objetivos secundarios: Evaluar la posible eficacia en cuanto a cierre de
    fístulas perianales complejas, reducción en el número de fístulas de
    drenaje durante dos visitas consecutivas, y porcentaje de sujetos con
    cicatrización de la fístula (medida por RM).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age 18 or over / Confirmed diagnosis of Crohn's disease a year before
    the inclusion date / Presence of perianal fistula / Identifiable internal
    orifice / Demonstration activity of the fistulizing perianal pathology
    based on clinical (including PDAI) and radiological (pelvic MRI and
    endoanal ultrasound) criteria / Presence of 3 or less fistulous tracts / No
    inflamatory activity in the rectum or proctitis (confirmed by
    colonoscopy) / Written informed consent
    Edad mayor de 18 años/ Diagnóstico confirmado de enfermedad de
    Crohn un año antes de la fecha de inclusión/ Presencia de patología
    fistulizante perianal/Orificio interno identificable/ Demostración de
    actividad de la patología fistulizante perianal en base a criterios clínicos
    (incluyendo PDAI) y radiológicos (RM pélvica y ecografía endoanal)/
    Presencia de 3 ó menos trayectos fistulosos/Ausencia de actividad
    inflamatoria rectal o proctitis (confirmada mediante colonoscopia) /
    Consentimiento informado obtenido por escrito
    E.4Principal exclusion criteria
    Superficial fistulas whose treatment of choice is fistulotomy / Presence
    of more than 3 fistulous tracts / Rectourethral and rectovaginal fistulas
    / Endoanal abscesses larger than 2 cm detected by physical examination
    or imaging (pelvic MRI endoanal ultrasound) / Current anorectal tumors
    / Clinically significant anal fissures or stenosis which prevent the
    rectoscopy or similar procedures / Impossibility of performing MRI for
    any reason (prosthesis, contrast allergy, claustrophobia ...) /
    Impossibility of performing endoanal ultrasound for any reason /
    Clinically inactive fistulizing disease (including PDAI) / Pregnant
    women or women in the first 6 months post-partum / Chemotherapy
    performed in the 6 months prior to study inclusion/ Bleeding diathesis or
    concurrent anticoagulant therapy / Prior
    radiation with evidence of radiation injury in the treatment area /
    Participation in any clinical trial during the 3 months prior to the
    screening visit / Other serious conditions or bio-psycho-social factors
    that may predict lack of compliance with study procedures / Major
    surgery or serious trauma of the subject in the previous semester /
    Congenital or acquired immunodeficiencies / Presence of surgical
    threads, unless they can be removed before starting treatment / Severe
    proctitis (striking friability, spontaneous bleeding, multiple erosions,
    deep ulcers), judging by the sigmoidoscopy / Malignancy in remission
    for less than a years before study inclusion, with the exception of basal
    cell carcinoma (BCC).
    Fístulas superficiales cuyo tratamiento de elección sea fistulotomía /
    Presencia de más de 3 trayectos fistulosos/Fístulas rectovaginales y
    rectouretrales/Presencia de abscesos de más de 2 cms detectados por
    exploración física o técnicas de imagen (RM pélvica o ecografía
    endoanal)/Tumores anorrectales actuales / Fisuras o estenosis anales
    clínicamente significativas que impidan la realización de rectoscopia o
    procedimientos similares / Imposibilidad de realización de RM por
    cualquier motivo que la contraindique (prótesis, alergia al contraste,
    claustrofobia?) / Imposibilidad de realización de ecografía endoanal por
    cualquier motivo que la contraindique / Pacientes con patología
    fistulizante clínicamente inactiva (incluyendo PDAI)/ Mujeres
    embarazadas o en los 6 meses postparto/Quimioterapia durante los 6
    meses anteriores al estudio /Diátesis hemorrágica o terapiaanticoagulante actual /Radiación previa con evidencia de lesión por radiación en
    el área a tratar/Participación en cualquier otro estudio clínico durante
    los 3 meses anteriores a la visita pre-estudio/Pacientes con otros
    trastornos graves o factores bio-psico-sociales que hagan previsible la
    falta de cumplimiento con los procedimientos del estudio /Cirugía mayor
    o traumatismo grave del sujeto en el semestre anterior/Sujetos con
    inmunodeficiencias congénitas o adquiridas/Presencia de sedales, salvo
    que se puedan retirar antes de iniciar el tratamiento/ Presencia de
    proctitis grave (friabilidad llamativa, sangrado espontáneo, erosiones
    múltiples, úlceras profundas) a juzgar por la rectosigmoidoscopia/
    Malignidades en remisión durante menos de un año antes de la inclusión
    en el estudio, con la excepción del carcinoma basocelular (CBC).
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of IMP-related adverse events during a follow-up period of 12
    months post-treatment.
    Incidencia de acontecimientos adversos relacionados con el producto en
    investigación durante un periodo de seguimiento de 12 meses postadministración.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 0, 2, 12, 22, 24, 36, 46 and 48.
    Semanas 0, 2, 12, 22, 24, 36, 46 and 48.
    E.5.2
    E.5.2Secondary end point(s)
    1. Ratio of complex perianal fistula closure in Crohn's disease patients,
    after 24 and 48 weeks of follow-up.
    2. Number of draining fistulas after two consecutive visits at weeks 22,
    24 and 46, 48.
    3. Percentage of subjects with healed fistula (measured by MRI) after 12
    and 24 weeks of follow-up.
    1. Ratio de cierre de fístulas complejas en enfermedad de Crohn perianal
    después de 24 y 48 semanas de seguimiento.
    2. Número de fístulas de drenaje durante dos visitas consecutivas en las
    semanas 22, 24 y 46, 48 de seguimiento.
    3. Porcentaje de sujetos con cicatrización de la fístula (medida por RM)
    tras 12 y 24 semanas de seguimiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 0, 2, 12, 22, 24, 36, 46 and 48.
    Semanas 0, 2, 12, 22, 24, 36, 46 and 48.
    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 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 No
    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 trial1
    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 No
    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
    Ultimo paciente, última visita
    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
    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.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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)
    Expected normal treatment for that condition
    Tratamiento normal esperado para esa condición
    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 Decision2012-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-08
    P. End of Trial
    P.End of Trial StatusOngoing
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