Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   41228   clinical trials with a EudraCT protocol, of which   6756   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-005001-20
    Sponsor's Protocol Code Number:HIVECR
    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:2015-03-03
    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 number2014-005001-20
    A.3Full title of the trial
    CHEMO-RESECTION WITH HYPERTHERMIC INTRAVESICAL INSTILLATION (HIVEC-R) VS STANDARD TREATMENT IN PATIENTS WITH NMIBT: COMPARATIVE, PROSPECTIVE AND RANDOMIZED STUDY OF EFFICACY AND TOLERABILITY
    QUIMIO-RESECCIÓN CON INSTILACIÓN INTRAVESICAL HIPERTÉRMICA (HIVEC-R) VS TRATAMIENTO ESTÁNDAR EN PACIENTES CON TVNMI: ESTUDIO COMPARATIVO, PROSPECTIVO Y RANDOMIZADO DE EFICACIA Y TOLERABILIDAD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CHEMO-RESECTION COMPARED WITH STANDARD TREATMENT FOR NMIBT
    QUIMIO-RESECCIÓN COMPARADO CON TRATAMIENTO ESTÁNDAR PARA TVNMI
    A.3.2Name or abbreviated title of the trial where available
    HIVEC - R
    HIVEC - R
    A.4.1Sponsor's protocol code numberHIVECR
    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 SponsorDR. ALEJANDRO SOUSA ESCANDÓN
    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 supportCOMBAT MEDICAL LTD
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHOSPITAL COMARCAL DE MONFORTE
    B.5.2Functional name of contact pointDR. ALEJANDRO SOUSA ESCANDÓN
    B.5.3 Address:
    B.5.3.1Street AddressC/CORREDOIRA S/N
    B.5.3.2Town/ cityMONFORTE DE LEMOS
    B.5.3.3Post code27400
    B.5.3.4CountrySpain
    B.5.4Telephone number+34607856407
    B.5.6E-mailsousa-alejandro@hotmail.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name MITOMYCIN-C
    D.2.1.1.2Name of the Marketing Authorisation holderINIBSA HOSPITAL S.L.U.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameMITOMYCIN-C
    D.3.4Pharmaceutical form Intravesical solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMITOMYCIN
    D.3.9.1CAS number 50-07-7
    D.3.9.4EV Substance CodeSUB09006MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    NMIBT
    TVNMI
    E.1.1.1Medical condition in easily understood language
    Superficial bladder cancer
    Cáncer vesical superficial
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    COMPARE EFFICACY OF NEOADJUNCTIVE THERAPY WITH CHEMO-HYPERTHERMIA WITH STANDARD ADJUNCTIVE THERAPY FOR NMIBT AT 24 MONTHS
    COMPARAR LA EFICACIA DEL TRATAMIENTO NEOADYUVANTE CON QUIMIIO-HYPERTHERMIA CON TRATAMIENTO ADYUVANTE ESTÁNDAR PARA EL TVNMI A LOS 24 MESES
    E.2.2Secondary objectives of the trial
    EVALUATE EFFICACY OF NEOADJUNCTIVE THERAPY IN TERMS OF COMPLETE AND PARTIAL RESPONSE AND COMPARE TOLERABILITY, QOL AND COST EFFECTIVENESS OF BOTH TREATMENT REGIMES
    EVALUAR EFICACIA EN TÉRMINOS DE RESPUESTA PARCIAL Y COMPLETA DEL TRATAMIENTO NEOAYUVANTE Y COMPARAR TOLERABILIDAD, CALIDAD DE VIDA Y COSTE EFECTIVIDAD DE AMBOS REGÍMENES DE TRATAMIENTO
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with NMIBC for which TURB is indicated except those recurrent with previous T1G3 or CIS in the last 12 moths and positive cytology
    - WHO scale 0, 1, 2, 3
    - Age ? 18 yrs
    - Normal kidneys and ureters
    - Pre-treatment haematology and biochemistry values within
    acceptable limits
    - Negative pregnancy test for women of child-bearing potential
    - Written informed consent (IC)
    - Paciente con TVNMI con indicación de próxima RTU vesical excepto paciente recurrente con T1G3 ó CIS previo en los últimos 12 meses y citología positiva.
    - Escala WHO 0, 1, 2, 3
    - Pacientes mayores de 18 años
    - Pacientes con vía urinaria superior normal
    - Pacientes con valores hematológicos y bioquímicos pre-tratamiento dentro de los límites aceptables
    - Test de embarazo negativo en mujeres en edad fértil con alguna posibilidad de estar embarazadas
    - Pacientes que hayan firmado el consentimiento informado (CI)
    E.4Principal exclusion criteria
    - Patient with solid tumor and muscle infiltrating aspect or with associated plane lesions suspicious for CIS
    - Recurrent patients with previous T1G3 or CIS in the last 12 months and positive cytology
    - Patients with hypersensitivity or allergy to MMC
    - History of limited vesical capacity (<200cc)
    - UCC involving the prostatic urethra or upper urinary tract
    - Pregnant or lactating women or women of childbearing potential
    unwilling or unable to use adequate non-hormonal contraception
    - Other malignancy within the past five years, except: nonmelanomatous
    skin cancer cured by excision, adequately treated
    carcinoma in situ of the cervix or DCIS/LCIS of the breast or prostate cancer.
    cancer.
    - Patients with tumours histologically different tan transitional cell
    carcinoma
    - Patients that for any reason should receive concurrent chemotherapy
    - Pacientes con tumor sólido y aspecto músculo infiltrante o con lesiones planas asociadas sospechosas de CIS
    - Pacientes recurrentes con T1G3 ó CIS previo en los últimos 12 meses y citología positiva.
    - Pacientes con hipersensibilidad o alergia a MMC
    - Pacientes con capacidad vesical limitada inferior a 200c.c.
    - Carcinoma de células uroteliales comprometiendo uretra prostática o tracto urinario superior
    - Mujeres embarazadas o en período de lactancia o mujeres en edad fértil que no deseen o no puedan usar anticonceptivos no hormonales
    - Pacientes con otros tumores malignos en los últimos 5 años excepto cáncer de piel no melanomatoso curado por escisión, carcinoma in situ de cérvix, carcinoma in situ ductal o lobular (DCIS/ LCIS) de cáncer de mama o cáncer de próstata tratados adecuadamente.
    - Pacientes con tumores histológicamente diferentes al carcinoma transicional de vejiga
    - Pacientes que por cualquier motivo deban recibir quimioterapia de forma simultánea
    E.5 End points
    E.5.1Primary end point(s)
    DFSR (Disease Free Survival Rate)
    TLE (Tiempo Libre de Enfermedad)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cytoscopy at week 4 and at 4, 8, 12, 18 and 24 months after treatment completion
    Cistoscopia a la semana 4 y al mes 4, 8, 12, 18 y 24 meses de seguimiento
    E.5.2Secondary end point(s)
    Complete and partial response of neoadjunctive therapy, tolerability, quality of life and cost effectiveness
    Respuesta parcial y completa del tratamiento neoayuvante, tolerabilidad, calidad de vida y coste efectividad
    E.5.2.1Timepoint(s) of evaluation of this end point
    Cytology at week 4, side effects reported by patient and healthcare professional before and after every instillation, qol questionnaire at screening visit and last visit.
    Citología en la semana 4, efectos secundarios reportados por profesional sanitario y paciente antes y después de cada instilación, cuestionario calidad de vida en la visita de screening y última visita
    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 Yes
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Terapia asistida por equipo
    Device assiisted therapy
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    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
    UVUS
    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 months6
    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.1.2.1Number of subjects for this age range: 34
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 state68
    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)
    None
    Ninguno
    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 Decision2015-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-03
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2021 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA