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    Summary
    EudraCT Number:2016-000823-24
    Sponsor's Protocol Code Number:P-HIPEC
    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:2021-06-08
    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 number2016-000823-24
    A.3Full title of the trial
    P-HIPEC CYTOREDUCTION
    PLUS HIPEC IN PATIENTS AFFECTED BY PERITONEAL CARCINOMATOSIS: A FEASIBILITY TRIAL
    P-HIPEC Fattibilit¿ della cito-riduzione
    associata ad HIPEC
    nei pazienti con carcinosi peritoneale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PERITONEAL NEOPLASTIC DISEASE TREATMENT BY SURGERY AND
    INTRA-ABDOMINAL INFUSION OF CHEMOTHERAPIC DRUGS
    TRATTAMENTO DELLE NEOPLASIE DEL
    PERITONEO MEDIANTE CHIRURGIA E SOMMINISTRAZIONE DI FARMACI CHEMIOTERAPICI IN CAVITA' ADDOMINALE
    A.3.2Name or abbreviated title of the trial where available
    P-HIPEC
    P-HIPEC
    A.4.1Sponsor's protocol code numberP-HIPEC
    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 OSPEDALIERO-UNIVERSITARIA DI MODENA
    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 supportCREMONINI SPA
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportBPER Banca Popolare Emilia Romagna
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportSignora Annunziata Albertini e Sig. Luigi Schiavi
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportSignora Marina Orlandi
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOU POLICLINICO DI MODENA
    B.5.2Functional name of contact pointSC CHIRURGIA 1
    B.5.3 Address:
    B.5.3.1Street Addressvia del Pozzo, 71
    B.5.3.2Town/ cityModena
    B.5.3.3Post code41124
    B.5.3.4CountryItaly
    B.5.4Telephone number0594223662
    B.5.5Fax number0594224370
    B.5.6E-mailchir1@unimore.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 MITOMYCIN C - 10 MG POLVERE PER SOLUZIONE INIETTABILE1 FLACONE
    D.2.1.1.2Name of the Marketing Authorisation holderPROSTRAKAN LIMITED
    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 nameMitomicina
    D.3.2Product code mittomicina
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMITOMICINA
    D.3.9.2Current sponsor codeMITOMICINA
    D.3.9.3Other descriptive nameMITOMYCIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCISPLATINO
    D.3.9.2Current sponsor codeCISPLATINO
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 100
    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 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) 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.IMP: 2
    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 DOXORUBICINA ACCORD HEALTHCARE ITALIA - 2MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 10MG/5ML
    D.2.1.1.2Name of the Marketing Authorisation holderACCORD HEALTHCARE ITALIA S.R.L.
    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 namedoxorubicina
    D.3.2Product code doxorubicina
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOXORUBICINA CLORIDRATO
    D.3.9.2Current sponsor codedoxorubicina
    D.3.9.3Other descriptive namedoxorubicin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number15 to 30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCISPLATINO
    D.3.9.2Current sponsor codecisplatino
    D.3.9.3Other descriptive namecisplatin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 100
    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 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) 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.IMP: 3
    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 CISPLATINO ACCORD HEALTHCARE ITALIA - 1 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO IN VETRO DA 100 ML
    D.2.1.1.2Name of the Marketing Authorisation holderACCORD HEALTHCARE ITALIA S.R.L.
    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 namecisplatino
    D.3.2Product code cisplatino
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCISPLATINO
    D.3.9.2Current sponsor codecisplatino
    D.3.9.3Other descriptive namecispatin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMITOMICINA
    D.3.9.2Current sponsor codemitomicina
    D.3.9.3Other descriptive namemitomycin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDOXORUBICINA CLORIDRATO
    D.3.9.2Current sponsor codedoxorubicina
    D.3.9.3Other descriptive namedoxorubicin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number15 to 30
    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 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) 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
    peritoneal carcinomatosis
    carcinosi peritoneale
    E.1.1.1Medical condition in easily understood language
    peritoneal carcinomatosis
    carcinosi peritoneale
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10026442
    E.1.2Term Malignant neoplasm of retroperitoneum and peritoneum
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10039867
    E.1.2Term Secondary malignant neoplasm of retroperitoneum and peritoneum
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    evaluate the feasibility of surgical cytoreduction
    associated to hypertemic intraperitoneal chemotherapy (HIPEC) in patients with peritoneal carcinomatosis
    valutare la fattibilit¿ della cito-riduzione chirurgica associata a chemio-ipertermia intraperitoneale
    (HIPEC) per pazienti affetti da carcinosi peritoneale
    E.2.2Secondary objectives of the trial
    evaluete the overall and disease free
    survival at 1, 3 and 5 years; evaluation of post-operative ccomplication rate and perioperative death
    valutare la sopravvivenza libera da malattia dopo il trattamento citoriduttivo e chemioterapico
    intraperitoneale; valutare la sopravvivenza globale a1,3 e 5 anni e intervallo libero da malattia a 1,3 e 5 anni dei pazienti dopo
    trattamento; valutare le complicanze legate al trattamento e la mortalit¿ perioperatoria
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    patients affected by peritoneal carcinomatosis by gastric, colon and ovarian cancer, pseudomixoma periotnei, peritoneal mesotelioma between 18 and 75 years old
    Saranno inclusi in questo studio tutti i pazienti affetti da carcinosi peritoneale di origine gastrica, colica, ovarica, mesotelioma peritoneale, pseudomixoma peritonei di età compresa tra i 18 e i 75 anni
    E.4Principal exclusion criteria
    peritoneal cancer index (PCI) >20;
    intraperitoneal unresectable disease;
    extraperiotneal disease;
    poor cardiac function (EF < 40%);
    poor renal function (creatinin > 1.5 time threshold or creatinin clearence< 60mL/min);
    poor epatic function (AST, ALT, Bilirubin >1.5 threshold);
    poor bone marrow function (WBC <4000mm3 or PMN <1500/mm3 or PLT <80000/mm3);
    poor pulmonary function (BCPO or rescrictive deficiency with FEV1 <50%, DLCO <40% of normal value adjusted for age).
    • peritoneal cancer index (PCI) >20;
    • malattia intraperitoneale non resecabile;
    • malattia extraperitoneale;
    • funzionalità cardiaca alterata (FE <40%);
    • funzionalità renale alterata (creatinina >1.5 volte il valore soglia oppure clearance della creatinina<60mL/min);
    • funzionalità epatica alterata (AST, ALT, bilirubina >1.5 volte il valore soglia);
    • funzionalità midollare alterata (WBC <4000/mm3 oppure PMN <1500/mm3 oppure PLT <80000/mm3);
    • funzionalità polmonare alterata (BPCO oppure deficit restrittivo con FEV1 <50% oppure DLCO <40% del valorenormale
    aggiustato per l’età)
    E.5 End points
    E.5.1Primary end point(s)
    feasibility of 80%: optimal cytoreduction
    with disease residue inferior to 2.5 mm (CCR0-1) and permorming HIPEC at the end of surgical procedure
    fattibilità del 80%: ottenimento di una cito-riduzione ottimale con un residuo di malattia inferiore ai
    2.5mm (CCR0-1) e l’effettuazione della chemio-ipertermia intraperitoneale al termine del tempo chirurgico
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 mesi
    E.5.2Secondary end point(s)
    major postoperative complications < 30%; perioperative mortality (within 30 days
    after treatment); Median survival in the overall treatment 1,3,5 years and stratified by disease; disease-free survival at 1,3,5 years after treatment
    complicanze postoperatorie maggiori < 30% ; mortalit¿ perioperatoria (entro 30gg dal trattamento) <3.9%; sopravvivenza media a 1,3,5 anni dal trattamento complessiva e stratificata per patologia; intervallo libero da malattia a 1,3,5 anni dal trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days; 30 days; 1,3,5 years from treatment; 1,3,5 years from treatment
    30 giorni; 30 giorni; 1,3,5 anni dal trattamento; 1,3,5 anni dal trattamento
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 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
    LVLS
    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 months30
    E.8.9.1In the Member State concerned days91
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months30
    E.8.9.2In all countries concerned by the trial days91
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 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 2021-06-08. Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    incapable adults
    adulti incapaci
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    follow up and or other oncological therapies
    follow up e successive terapie oncologiche
    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 Decision2016-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-14
    P. End of Trial
    P.End of Trial StatusOngoing
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