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    The EU Clinical Trials Register currently displays   41501   clinical trials with a EudraCT protocol, of which   6826   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2018-003507-19
    Sponsor's Protocol Code Number:HOPE9
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-003507-19
    A.3Full title of the trial
    “Phase III, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy of pre-surgical HPV 9-valent vaccination in women treated with electrosurgical excision with diathermic loop (LEEP) for high-grade cervical intraepithelial neoplasia (CIN2 +) up to initially invasive cervical cancer (FIGO IA1) - HOPE 9 STUDY”
    “Studio di fase III, randomizzato, in doppio cieco, controllato con placebo multicentrico, per valutare l’efficacia della vaccinazione anti HPV 9-valente pre-chirurgica in donne trattate con escissione elettrochirurgica con ansa diatermica (LEEP) per neoplasia cervicale intraepiteliale di alto grado (CIN2+) fino a cancro cervicale inizialmente invasivo (FIGO IA1) - HOPE 9 STUDY”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact on Disease Relapse of HPV Vaccination in Women Treated With electrosurgical excision with diathermic loop (LEEP) for Cervical Intraepithelial Neoplasia.
    Impatto sulla recidiva di malattia della vaccinazione anti-HPV nelle donne trattate con escissione elettrochirurgica con ansa diatermica (LEEP) per neoplasia cervicale intraepiteliale.
    A.3.2Name or abbreviated title of the trial where available
    HOPE9
    HOPE9
    A.4.1Sponsor's protocol code numberHOPE9
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03848039
    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 SponsorAZIENDA USL TOSCANA NORD OVEST
    B.1.3.4CountryItaly
    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 supportMSD ITALIA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAZIENDA USL TOSCANA NORD OVEST
    B.5.2Functional name of contact pointTASK FORCE SPERIMENTAZIONI
    B.5.3 Address:
    B.5.3.1Street AddressVIA COCCHI 7/9
    B.5.3.2Town/ cityPISA
    B.5.3.3Post code56121
    B.5.3.4CountryItaly
    B.5.4Telephone number0586223031
    B.5.5Fax number0586223217
    B.5.6E-mailsperimentazioni.cliniche@uslnordovest.toscana.it
    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 GARDASIL9 0,5 ml - sospensione iniettabile - uso intramuscolare – siringa pre-riempita (vetro) - 1 siringa preriempita + 2 aghi
    D.2.1.1.2Name of the Marketing Authorisation holderMSD ITALIA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameGARDASIL9 0,5 ml - sospensione iniettabile - uso intramuscolare – siringa pre-riempita (vetro) - 1 s
    D.3.2Product code [GARDASIL9 0, 5 ml - sospensione iniettabile - uso
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPapillomavirus (tipi umani 6,11,16,18,31,33, 45,52,58)
    D.3.9.2Current sponsor codeProteina L1 tipi 6,11,16,18,31,33, 45,52,58 di Papillomavirus umano
    D.3.10 Strength
    D.3.10.1Concentration unit DF dosage form
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolvent for parenteral use
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevention of recurrence after a first episode of high-grade cervical intraepithelial neoplasia (CIN2 +) up to initially invasive cervical cancer (FIGO IA1)
    Prevenzione della recidiva dopo un primo episodio di neoplasia cervicale intraepiteliale di alto grado (CIN2+) fino a cancro cervicale inizialmente invasivo (FIGO IA1)
    E.1.1.1Medical condition in easily understood language
    Prevention of recurrence after a first episode of high-grade cervical intraepithelial neoplasia up to initially invasive cervical cancer
    Prevenzione della recidiva di malattia dopo un primo episodio di neoplasia cervicale intraepiteliale di alto grado fino a cancro della cervice inizialmente invasivo
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008229
    E.1.2Term Cervical cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10056576
    E.1.2Term Cervical intraepithelial neoplasia
    E.1.2System Organ Class 100000004872
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10064328
    E.1.2Term Human papilloma virus test positive
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the impact of pre-surgical HPV 9-valent vaccination in patients subjected to conization for the management of high-grade cervical intraepithelial neoplasia (CIN2 +) and initially invasive cervical cancer in terms of possible reduction of recurrent post-surgical disease.
    Valutare l'impatto della vaccinazione anti HPV 9-valente pre-chirurgica in pazienti sottoposte a conizzazione per la gestione della neoplasia cervicale intraepiteliale di alto grado (CIN2+) e del cancro cervicale inizialmente invasivo in termini di possibile riduzione di recidiva di malattia post chirurgica.
    E.2.2Secondary objectives of the trial
    1. Analysis of the possible impact of the 9-valent vaccine on the post-surgical natural history of HPV infection.
    2. Evaluation of 9-valent HPV vaccination in patients treated for CIN2 + in terms of possible reduction of the follow-up scheme in the cervical screening program (investigation on the possible temporal reduction of post-surgical surveillance).
    1. Analisi del possibile impatto del vaccino 9-valente sulla storia naturale post-chirurgica dell'infezione da HPV.
    2. Valutazione della vaccinazione anti HPV 9-valente nelle pazienti trattate per CIN2+ in termini di possibile riduzione dello schema di follow-up nel programma di screening cervicale (indagine sulla possibile riduzione temporale della sorveglianza post-chirurgica).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients = 18 years old and ecog performance status = 1
    2. Patients diagnosed with high-grade cervical intraepithelial neoplasia or initially invasive cervical cancer (histological findings = CIN2 + and = Ia1 according to the FIGO staging of cervical cancer)
    3. No fever at the time of vaccination
    4. No previous HPV vaccination
    5. Ability to understand and write in Italian
    6. Signature of informed consent and consent to personal data
    1. Pazienti di età =18 anni e con ecog performance status = 1
    2. Pazienti con diagnosi di neoplasia intraepiteliale cervicale di alto grado o cancro cervicale inizialmente invasivo (risultati istologici = CIN2+ e = Ia1 secondo la stadiazione FIGO del cancro cervicale)
    3. Assenza di febbre al momento della vaccinazione
    4. Assenza di pregressa vaccinazione anti HPV
    5. Capacità di comprendere e scrivere in italiano
    6. Firma del consenso informato e del consenso al trattamento dei dati personali
    E.4Principal exclusion criteria
    1. Patients enrolled in other clinical trials
    2. History of allergic reaction or serious adverse events to previous vaccinations
    3. Assessment of the state of pregnancy at the time of vaccination
    4. Patients on immunosuppressive therapy
    5. Subjects who received immunoglobulins or blood products in the 3 months prior to vaccination.
    6. Thrombocytopenia or any other coagulation disorder that may lead to bleeding following intramuscular administration
    7. Clinical criteria contraindicating the surgical act of conization
    8. ECOG performance status =2
    1. Pazienti arruolate in altri studi clinici
    2. Storia di reazione allergica o gravi eventi avversi a precedenti vaccinazioni
    3. Accertamento dello stato di gravidanza al momento della vaccinazione
    4. Pazienti in terapia immunosoppressiva
    5. Soggetti che hanno ricevuto immunoglobuline o emoderivati nei 3 mesi precedenti alla vaccinazione.
    6. Trombocitopenia o ogni altro disturbo della coagulazione che possa portare al verificarsi di un sanguinamento a seguito della somministrazione per via intramuscolare
    7. Criteri clinici controindicanti l’atto chirurgico di conizzazione
    8. ECOG performance status =2
    E.5 End points
    E.5.1Primary end point(s)
    - evaluation of the reduction of disease recurrence (cervical intraepithelial neoplasia up to microinvasive cervical cancer) by comparing the number of recurrences in the two arms.
    - valutazione riduzione delle recidive di malattia (neoplasia cervicale intraepiteliale fino cancro microinvasivo della cervice) mediante confronto della numerosità delle recidive nei due bracci.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the entire duration of the study
    Per tutta la durata dello studio
    E.5.2Secondary end point(s)
    Analysis of the impact of the vaccine on prevalent post-surgery infections by comparing the prevalence of persistent HPV infections (duration greater than 12 months after surgery) in the two arms.; Analysis of the impact of the vaccine in the post-surgical surveillance times, comparison of the viral wash-out times (negativity of the HPV test), times of negativization of the pap test and of the colposcopic exam in the post-operative period: comparison of the overexposed times of negativization in the two arms.
    Analisi dell’impatto del vaccino sulle infezioni prevalenti post chirurgia mediante confronto della prevalenza delle infezioni persistenti HPV (durata maggiore di 12 mesi dalla chirurgia) nei due bracci.; Analisi dell’impatto del vaccino nei tempi di sorveglianza post chirurgica, confronto dei tempi di wash-out virale (negativizzazione del test HPV), tempi di negativizzazione del pap test e del quadro colposcopico nel periodo post operatorio: confronto dei tempi di negativizzazione sovraesposti nei due bracci.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the entire duration of the study; During the entire duration of the study
    Per tutta la durata dello studio; Per tutta la durata dello studio
    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 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 concerned9
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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 - Last Visit Last Subject
    ultima visita dell'ultimo soggetto - LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months90
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months90
    E.8.9.2In all countries concerned by the trial 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: 1200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-05-24. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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 state1220
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1220
    F.4.2.2In the whole clinical trial 1220
    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)
    As a routine clinical practice
    Come normale pratica clinica
    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 Decision2020-09-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-10
    P. End of Trial
    P.End of Trial StatusOngoing
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