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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:2016-001186-85
    Sponsor's Protocol Code Number:HIVEC-HR
    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:2016-06-01
    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 number2016-001186-85
    A.3Full title of the trial
    HIVEC HR: USE OF CHEMOHYPERTHERMIA WITH INTRAVESICAL MITOMYCIN (HIVEC) FOR THE TREATMENT OF PATIENTS WITH NMIBC AND HIGH RISK (HR)
    HIVEC HR: USO DE LA QUIMIOHIPERTERMIA CON MITOMICINA INTRAVESICAL HIVEC) COMO TRATAMIENTO DEL PACIENTE CON TUMOR VESICULA NO MÚSCULO INFILTRANTE DE RIESGO ALTO (HR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    HIVEC HR: USE OF CHEMOHYPERTHERMIA WITH INTRAVESICAL MITOMYCIN (HIVEC) FOR THE TREATMENT OF PATIENTS WITH NMIBC AND HIGH RISK (HR)
    HIVEC HR: USO DE LA QUIMIOHIPERTERMIA CON MITOMICINA INTRAVESICAL HIVEC) COMO TRATAMIENTO DEL PACIENTE CON TUMOR VESICULA NO MÚSCULO INFILTRANTE DE RIESGO ALTO (HR)
    A.3.2Name or abbreviated title of the trial where available
    HIVEC HR
    HIVEC HR
    A.4.1Sponsor's protocol code numberHIVEC-HR
    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. Felipe Villacampa
    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 supportLaboratorios Inibsa
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr. Felipe Villacampa
    B.5.2Functional name of contact pointHospital Universitario 12 Octubre
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Córdoba s/n
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28041
    B.5.3.4CountrySpain
    B.5.4Telephone number+34637569593
    B.5.6E-mailfvillacampa@yahoo.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 Yes
    D.2.1.1.1Trade name Mitomycin-C
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratorios Inibsa
    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 Yes
    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 Muscle Invasive Bladder Cancer
    Tumor Vesical No Músculo Infiltrante
    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
    Evaluate disease free survival time after 24 months follow up of TURBT followed by HIVEC compared with TURBT followed by standard BCG therapy
    Evaluar el tiempo libre de enfermedad tras 24 meses de seguimiento de la RTU vesical seguido de tratamiento con HIVEC comparado con RTU vesical seguida de tratamiento estándar con BCG
    E.2.2Secondary objectives of the trial
    1. Time to progression of HIVEC vs. BCG
    2. Cancer specific survival of HIVEC vs BCG
    3. Adverse Events of HIVEC vs BCG
    4. QoL of HIVEC vs. BCG
    1. Tiempo hasta progresión de HIVEC vs. BCG
    2. Supervivencia cáncer específica
    3. Efectos secundarios HIVEC vs. BCG
    4. Calidad de Vida HIVEC vs. BCG
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. All patients operated of non invasive bladder tumour that meet high
    risk criteria as per EORTC risk categories
    2. Above 18 years old
    3. Accept to participate in the trial and sign the consent form
    1. Todos los pacientes operados de tumor no infiltrante de vejiga que
    cumplan criterios de riesgo elevado según EORTC
    2. Mayores de edad
    3. Acepten ser incluidos en el estudio y firmen el consentimiento
    informado
    E.4Principal exclusion criteria
    1. Patients with invasive lesions or CIS
    2. Hypersensitivity or allergy to MMC
    3. History of severe adverse reaction to BCG
    4. Epithelial cells carcinoma involving prostatic urethra or upper urinary
    tract
    5. Patients with tumors histologically different than transitional cell
    carcinoma
    6. Patients that for any reason should receive simultaneous
    chemotherapy
    7. Withdrawal of CI
    8. Pregnant or lactating or women of childbearing age
    who do not want or can not use non-hormonal contraceptives
    9. Urethral stenosis that contraindicates catheterization for the
    instillation
    10. Treatment with immunosuppressants that contraindicates BCG
    therapy
    1. Pacientes con tumor músculo infiltrante, o con Carcinoma In Situ.
    2. Hipersensibilidad o alergia a la mitomicina.
    3. Antecedentes de reaccion adversa severa a BCG.
    4. Carcinoma de células uroteliales comprometiendo uretra prostática o
    tracto urinario superior
    5. Pacientes con tumores histológicamente diferentes al carcinoma
    transicional de vejiga
    6. Pacientes que por cualquier motivo deban recibir quimioterapia de
    forma simultánea
    7. Rechazo o retirada del consentimiento
    8. Mujeres embarazadas o en período de lactancia o mujeres en edad
    fértil que no deseen o no puedan usar anticonceptivos no hormonales
    9. Estenosis de uretra que contraindique el sondaje para la instilación.
    10. Tratamiento con inmunosupresores que contraindique la instilación
    con BCG.
    E.5 End points
    E.5.1Primary end point(s)
    Disease Free survival after 24 months follow up
    Tiempo libre de enfermedad tras 24 meses de seguimiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months after last instillation
    24 meses tras la última instilación
    E.5.2Secondary end point(s)
    1. Time to progression
    2. Cancer specific survival
    3. Adverse Events of HIVEC compared with BCG
    4. Quality of Life
    2. Tiempo libre de progresión
    3. Supervivencia cáncer específica.
    4. Efectos secundarios en la aplicación de la QHT comparado con
    efectos secundarios en la aplicación de la BCG.
    XML File Identifier: 4Rd8nkFs5x0FoMjXgBed5MQiTZg=
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    5. Medición de calidad de vida
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 months after the last instillation
    24 meses tras la última instilación
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    Calidad de Vida
    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) Yes
    E.8.2.2Placebo No
    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
    Last Visit Last Subject
    Ultima Visita Último Paciente
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state50
    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)
    Normal treatment of that condition
    Tratamiento habitual para su enfermedad
    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 Decision2016-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-29
    P. End of Trial
    P.End of Trial StatusOngoing
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