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    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) .
     
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    Summary
    EudraCT Number:2013-002628-18
    Sponsor's Protocol Code Number:HIVECI
    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:2013-08-01
    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 number2013-002628-18
    A.3Full title of the trial
    HIVEC (Hyperthermic IntraVEsical Chemotherapy) FOR PATIENTS WITH INTERMEDIATE RISK NMIBC COMPARED WITH STANDARD INTRAVESICAL INSTILLATION OF CHEMOTHERAPY AS ADYUVANT TREATMENT.
    A COMPARATIVE, PROSPECTIVE, RANDOMIZED STUDY.
    HIVEC (Quimioterapia Intravesical Hipertérmica) PARA PACIENTES CON TVNMI RIESGO INTERMEDIO COMPARADO CON INSTILACIÓN INTRAVESICAL DE QUIMIOTERAPIA ESTÁNDAR COMO TRATAMIENTO ADYUVANTE. ESTUDIO COMPARATIVO, PROSPECTIVO, RANDOMIZADO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFECT OF HYPERTHERMIA IN THE TREATMENT OF SUPERFICIAL BLADDER CANCER
    EFECTO DE LA HIPERTERMIA EN EL TRATAMIENTO DEL CÁNCER SUPERFICIAL DE VEJIGA
    A.3.2Name or abbreviated title of the trial where available
    HIVEC I
    HIVEC I
    A.4.1Sponsor's protocol code numberHIVECI
    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 SponsorCOMBAT MEDICAL LTD
    B.1.3.4CountryUnited Kingdom
    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 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, LUGO
    B.5.3.3Post code27400
    B.5.3.4CountrySpain
    B.5.4Telephone number+34982403795
    B.5.5Fax number+34918874444
    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 number40
    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
    NON MUSCULAR INVASIVE BLADDER CANCER WITH INTERMEDIATE RISK OF RECURRENCE
    TUMOR VESICAL NO MÚSCULO INVASIVO CON RIESGO INTERMEDIO DE RECURRENCIA
    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 the efficacy in terms of disease-free survival after 24 months of follow of hyperthermic vs. non hyperthermic intravesical instillation with Mitomycin
    Comparar la eficacia en términos de supervivencia libre de enfermedad tras 24 meses de seguimiento de instilación intravesical con Mitomicina hipertérmica vs. no hipertérmica
    E.2.2Secondary objectives of the trial
    To compare the tolerability, recurrence rate, time to progression and quality of life after 24 months of follow up, of hyperthermic vs non hyperthermic intravesical chemotherapy
    Comparar la tolerabilidad, tasa de recurrencia, tiempo hasta progresión y calidad de vida, tras 24 meses de seguimiento, de instilación intravesical con Mitomicina hipertérmica vs. no hipertérmica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. New or Recurrence of intermediate risk NMIBC following TURBT defined as;
    ? Grade 2 or grade 1 stage T1 disease
    ? Any grade G2 or G1 other than Low risk
    2. Age ? 18 yrs
    3. WHO performance status 0, 1, 2, 3
    4. Normal kidneys and ureters on imaging study within the past 12 months**
    5. Pre-treatment haematology and biochemistry values within acceptable limits:
    - haemoglobin ? 10 g/dl
    - neutrophil count ? 1.5 x 109/l
    - platelets ? 100 x 109/l
    - WBC ? 3.0 x 109/l or ANC ? 1.5 x 109/l
    - Serum creatinine < 1.5 x UNL
    6. Negative pregnancy test for women of child-bearing potential.
    7. Available for long-term follow-up.
    8. Written informed consent.
    1. Paciente con TVNMI nuevo o recurrente al que se haya practicado RTU con riesgo intermedio de recidiva definido como
    ? Grado 2 o Grado 1 estadío T1*
    ? Cualquier Grado 1 o Grado 2 que no sea bajo riesgo
    2. Escala WHO 0, 1, 2, 3
    3. Pacientes mayores de 18 años
    4. Pacientes con riñones y uréteres normales según prueba de imagen realizada en los últimos 12 meses
    5. Pacientes con valores hematológicos y bioquímicos pre-tratamiento dentro de los límites aceptables:
    ? Hemoglobina ?10g/dl
    ? Neutrófilos ? 1.5 x 109/l
    ? Plaquetas ? 100 x 109/l
    ? WBC ? 3.0 x 109/l ó ANC ? 1.5 x 109/l
    ? Creatinina Sérica < 1.5 x UNL
    6. Test de embarazo negativo en mujeres en edad fértil con alguna posibilidad de estar embarazadas.
    7. Con posibilidad de realizar seguimiento a largo plazo.
    8. Pacientes que hayan firmado el consentimiento informado
    E.4Principal exclusion criteria
    1. Patients with any of the following conditions:
    - Grade 3 UCC.
    - CIS
    - Primary Solitary Ta G1<3cm
    - Primary Solitary Ta G2 <3cm
    2. ?T2 UCC
    3. Previous intravesical chemotherapy in the past 6 months, other than single instillation post-TUR.
    4. History of limited vesical capacity (<200cc)
    5. UCC involving the prostatic urethra or upper urinary tract.
    6. Known allergy to MMC
    7. Pregnant or lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception.
    8. Other malignancy within the past five years, except: non-melanomatous skin cancer cured by excision, adequately treated carcinoma in situ of the cervix or DCIS/LCIS of the breast or prostate cancer with less than 5yrs life expectancy.
    9. Patients with tumours histologically different tan transitional cell carcinoma
    10. Concurrent chemotherapy.
    1. Pacientes con alguna de las siguientes características
    ? Grado 3 TCC
    ? CIS
    ? Tumor primario único TaG1<3cm
    ? Tumor primario único TaG2<3cm
    2. Pacientes con estadiaje >T2 TCC
    3. Pacientes que hayan sigo tratados con quimioterapia intravesical en los últimos 6 meses excepto aquellos que hayan recibido únicamente instilación inmediata post RTU
    4. Pacientes con hipersensibilidad o alergia a MMC
    5. Pacientes con capacidad vesical limitada inferior a 200c.c.
    6. Carcinoma de células uroteliales comprometiendo uretra prostática o tracto urinario superior
    7. Mujeres embarazadas o en período de lactancia o mujeres en edad fértil que no deseen o no puedan usar anticonceptivos no hormonales
    8. Pacientes con otros tumores malignos en los últimos 5 años excepto cáncer de piel no melanomatoso curado por escisión, carcinoma in situ de cérvix tratado adecuadamente, carcinoma in situ ductal o lobular (DCIS/ LCIS) de cáncer de mama o próstata con menos de 5 años de esperanza de vida
    9. Pacientes con tumores histológicamente diferentes al carcinoma transicional de vejiga.
    10. Pacientes que por cualquier motivo deban recibir quimioterapia de forma simultánea.
    E.5 End points
    E.5.1Primary end point(s)
    EFFICACY PARAMETERS

    ? Disease-free survival
    ? Recurrence rate
    ? Time to progression
    PARÁMETROS DE EFICACIA:
    ? Supervivencia libre de enfermedad
    ? Tasa de recurrencia
    ? Tiempo hasta la progresión
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cystoscopy at the end of the treatment and at 4, 8, 12, 18 and 24 months of follow up
    Cistoscopia al final del tratamiento y a los 4, 8, 12, 18 y 24 meses de seguimiento
    E.5.2Secondary end point(s)
    Safety Parameters
    - Dysuria, Urinary frequency, nocturia by IPSS scale
    - Graded visual pain scale (VAS)
    - Others reported by the health professional
    - EORTC Quality of Life Questionnaire QLQ-BLS24
    PARÁMETROS DE SEGURIDAD
    - Disuria, Polaquiuria, nicturia mediante escala IPSS
    - Escala visual de dolor graduada (VAS)
    - Otros manifestados por el profesional sanitario (dificultad de sondaje, hematuria, rash cutáneo, calor)
    - Calidad de Vida Cuestionario EORTC QLQ-BLS24
    E.5.2.1Timepoint(s) of evaluation of this end point
    ? Before each new instillation: the patient will report any side effect occurred from the last instillation.
    ? After the instillation:
    - the patient will report any side effect occurred during the present instillation.
    - healthcare professional will report any other side effect occurred during the present instillation.
    ? The quality of life questionnaire will be completed by the patients before receiving adjuvant treatment and repeated in the last study visit.
    ? Antes de cada nueva instilación el paciente reportará el estado miccional desde la última dosis
    ? Al finalizar la instilación:
    - el paciente reportará la sensación de dolor de la instilación recibida
    - el profesional sanitario evaluará cada una de los ciclos recibidos de forma independiente
    ? El cuestionario de calidad de vida será cumplimentado por el pacientes antes de recibir el tratamiento adyuvante y se repetirá en la última visita del estudio.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 device
    Device assisted therapy
    E.8.2.4Number of treatment arms in the trial3
    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 concerned7
    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
    Ultima visita último sujeto
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state300
    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
    Ninguna
    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 Decision2013-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-05
    P. End of Trial
    P.End of Trial StatusOngoing
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