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    Summary
    EudraCT Number:2017-001209-34
    Sponsor's Protocol Code Number:PRGFFC17
    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:2017-09-18
    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 number2017-001209-34
    A.3Full title of the trial
    Phase III CLINICAL TRIAL, MULCHNTRIC, RANDOMIZED, BLIND DOUBLE IN
    TWO PARALLEL GROUPS TO COMPARE THE EFFECTIVENESS AND SAFETY OF THE SIMPLE CLOSURE OF THE CRYPTTOGLANDULAR ANAL FISTULA WITH OR WITHOUT THE ADJUVANT ADMINISTRATION OF PLASMA RICO IN
    GROWTH FACTORS (ENDORET® / PRGF® TECHNOLOGY), IN A PERIOD OF 48 WEEKS
    ENSAYO CLÍNICO FASE III, MULCÉNTRICO, ALEATORIZADO, DOBLE CIEGO EN
    DOS GRUPOS PARALELOS PARA COMPARAR LA EFICACIA Y SEGURIDAD DEL CIERRE SIMPLE DE LA FÍSTULA ANAL CRIPTOGLANDULAR CON O SIN LA ADMINISTRACIÓN ADYUVANTE DE PLASMA RICO EN
    FACTORES DE CRECIMIENTO (TECNOLOGÍA ENDORET®/PRGF®), EN UN PERIODO DE 48 SEMANAS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STUDY TO DETERMINE AS EFFECTIVE AND SAFE IS THE RICH PLASMA IN GROWTH FACTORS IN THE TREATMENT OF A TYPE OF ANAL FISTULA IN COMPARISON WITH PLACEBO
    ESTUDIO PARA DETERMINAR COMO DE EFICAZ Y SEGURO ES EL PLASMA RICO EN FACTORES DE CRECIMIENTO EN EL TRATAMIENTO DE UN TIPO DE FÍSTULA ANAL EN COMPARACIÓN CON PLACEBO
    A.3.2Name or abbreviated title of the trial where available
    PRGF IN ACF
    PRGF EN FAC
    A.4.1Sponsor's protocol code numberPRGFFC17
    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 SponsorFISEVI
    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 supportFISEVI
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFISEVI
    B.5.2Functional name of contact pointFISEVI
    B.5.3 Address:
    B.5.3.1Street AddressAVDA MANUEL SIUROT S/N
    B.5.3.2Town/ citySEVILLA/SEVILLA
    B.5.3.3Post code41013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34954012292
    B.5.6E-maildelaportilla@ucpsevilla.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 namePLATELET RICH FACTORS
    D.3.2Product code other plasma protein fractions
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPRGF
    D.3.9.3Other descriptive namePLATELETS
    D.3.9.4EV Substance CodeSUB25592
    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
    Patients with anal fistula
    Los pacientes tienen diagnosticada una fistula anal compleja del tipo criptoglandular con un orificio interno y uno externo.
    E.1.1.1Medical condition in easily understood language
    Although most fistulas are simple and can be solved easily fewer cases
    of them are complex, since it must preserve continence, while
    eradicates the suppurative process
    Aunque la mayoría de las fístulas son simples un menor número de
    ellas son complejas, constituyendo un reto puesto que debe preservarse
    la continencia, a la vez que erradica el proceso supurativo
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of the study was to evaluate the efficacy and safety of plasma rich in growth factors as adjuvant to curettage and simple closure of the internal orifice compared to a control group (serum) in patients with complex cryptoglandular anal fistulas. Efficacy and safety will be monitored for a total of 12 months after completion of treatment.

    Primary objective
    To assess efficacy by the proportion of responders after 12 months of treatment, compared with responders to placebo.
    El objetivo del estudio es evaluar la eficacia y seguridad del plasma rico en factores de crecimiento como adyuvante al curetaje y cierre simple del orifico interno en comparación con un grupo control (suero) en pacientes con fistulas anales criptoglandulares complejas. Se realizará un seguimiento de la eficacia y seguridad durante un total de 12 meses después de la finalización del tratamiento.

    Objetivo primario
    Evaluar la eficacia mediante la proporción de pacientes respondedores al cabo de los 12 meses de terminado el tratamiento, comparando con los respondedores al placebo.
    E.2.2Secondary objectives of the trial
    Secondary Objectives

    The secondary efficacy endpoints (comparing both groups) are as follows:
    - Evaluate the clinical response - total or partial - at each visit and at the end of the trial, with respect to the baseline data.
    - Evaluate the time to clinical remission - total or partial - defined at each visit and at the end of the trial, compared to the baseline data.
    - Evaluate the response by endoanal ultrasound / MRI at the end of the trial with respect to baseline ultrasound data.
    - Evaluate the variations in the quality of life assessed by the Quality of Life Questionnaire SF36 at each visit and at the end of the trial, compared to the baseline data.

    The safety assessment will be part of the secondary endpoints and will include potential PRFG adverse events measured by recording adverse events reported during the study and the clinical findings of physical examination. The evaluation will also consider the assessment of fecal incontinence.
    Objetivos secundarios
    - Evaluar la respuesta clínica –total o parcial-, en cada visita y a la finalización del ensayo, respecto a los datos basales.
    - Evaluar el tiempo hasta la remisión clínica –total o parcial- definida en cada visita y a la finalización del ensayo, respecto a los datos basales.
    - Evaluar la respuesta mediante ecografía endoanal/RM al final del ensayo respecto a los datos ecográficos basales.
    - Evaluar las variaciones de la calidad de vida, valorada mediante el Cuestionario de calidad de vida SF36 en cada visita y a la finalización del ensayo, respecto a los datos basales.

    La evaluación de la seguridad formará parte de los criterios de valoración secundarios e incluirá los posibles acontecimientos adversos de PRFG, medida mediante el registro de los acontecimientos adversos notificados durante el estudio y los hallazgos clínicos de la exploración física. En dicha evaluación se considerará también la valoración de incontinencia fecal.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Signature of consent, age greater than 18 years and complex fistulas of cryptoglandular origin with a single path, and equal number of internal and external holes.
    Firma de consentimiento, edad mayor de 18 años y fístulas anales de origen criptoglandular complejas con un único trayecto, e igual número de orificios interno y externos.
    E.4Principal exclusion criteria
    Non-resolved interposed or coexisting collections, non-localization of the internal orifice, simple fistula (submucosal / subcutaneous / low-interphosphorylated), pregnant, active or past cancer in less than 5 years, HIH, anal stricture to prevent anal fistula exploration, allergy To the sealing product used, rectovaginal fistulas, active or non-rectal inflammatory disease, inability to follow up, platelet antiplatelet therapy that can not be discontinued at least one week before surgery and one week later patients receiving Currently any investigational drug, or have received it within 3 months prior to enrollment in this clinical trial.
    Colecciones interpuestas o coexistentes no resueltas, no localización del orificio interno, fístula simples (submucosas/subcutáneas/interesfinterianas bajas), embarazadas, cáncer activo o pasado en menos de 5 años, HIH, estenosis anal que impida la exploración de la fístula anal, alergia al producto de sellado empleado, fístulas rectovaginales, enfermedad de inflamatoria activa o no de recto, imposibilidad de cumplimiento del seguimiento, toma de antiagregante plaquetario que no pueda ser suspendido al menos una semana antes de la cirugía y una semana después, pacientes que estén recibiendo actualmente cualquier fármaco en investigación, o lo hayan recibido en los 3 meses previos a la inscripción en este estudio clínico.
    E.5 End points
    E.5.1Primary end point(s)
    The fistula is considered cured when the external fistula orifice, are
    closed and / or does not drain after compression finger. Persistence of
    symptoms after three months of surgery: recurrence and / or failure of
    treatment is considered.
    La Fístula se considera curada cuando el orificio fistuloso externo, esta
    cerrado y/o no drena, tras compresión con dedo. Se considera
    recurrencia y/o fracaso de tratamiento: persistencia de síntomas
    después de tres meses de la cirugía.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At three, six, and twelve months after treatment
    A los 3, 6 y 12 meses post tratamiento
    E.5.2Secondary end point(s)
    The safety assessment will be part of the secondary endpoints and
    include possible adverse events PRGF measured by recording adverse
    events reported during the study and clinical findings of the physical
    examination. The evaluation will also consider the evaluation of fecal
    incontinence.
    La evaluación de la seguridad formará parte de los criterios de
    valoración secundarios e incluirá los posibles acontecimientos adversos
    de PRFG, medida mediante el registro de los acontecimientos adversos
    notificados durante el estudio y los hallazgos clínicos de la exploración
    física. En dicha evaluación se considerará también la valoración de
    incontinencia fecal
    E.5.2.1Timepoint(s) of evaluation of this end point
    At three, six, and twelve months after treatment
    A los 3, 6 y 12 meses post tratamiento
    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 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 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
    complete cure, defined as 1 year after discharge or no stained by OFE
    and this is completely re-epithelized. A partial cure when within 1 year
    after the seal has not stained by oozing or OFE, but it is completely reepithelized
    NO.
    The primary efficacy was measured at each follow-up period (1, 3, 6
    months), the secondary efficacy measure after one year follow-up after
    treatment
    curación completa, se define cuando al cabo de 1 año no presenta
    supuración ni manchado por el OFE y este se encuentra totalmente
    reepitelizado. Un curación parcial cuando al cabo de 1 año posterior al
    sellado no presenta supuración ni manchado por el OFE, pero el éste
    NO se encuentra totalmente reepitelizado.
    La eficacia primaria se medirá en cada periodo de seguimiento (1, 3, 6
    meses), la eficacia secundaria se medirá al cabo de un año de
    seguimiento tras tratamiento
    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: 100
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    Monitoring and control by surgery to see if the fistula again recidivarse
    According to clinical practice
    Seguimiento y control por parte de cirugía para ver si vuelve a
    recidivarse la fístula
    Según práctica clínica habitual
    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 Decision2018-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-22
    P. End of Trial
    P.End of Trial StatusOngoing
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