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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2019-000514-11
    Sponsor's Protocol Code Number:SAKK01/18
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-10-17
    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 ConcernedGermany - BfArM
    A.2EudraCT number2019-000514-11
    A.3Full title of the trial
    Reduced intensity radio-chemotherapy for stage IIA/B seminoma. A multicenter, open label phase II trial with two cohorts
    Radio-Chemotherapie mit reduzierter Intensität bei Patienten mit einem Seminom des Stadiums IIA/B. Eine multizentrische, offene Phase-II-Studie mit zwei Patientengruppen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Combination of radio- and chemotherapy for patients with stage IIA/B seminoma with reduced intesity.
    Kombination aus Strahlen- und Chemotherapie mit verminderter Intensität bei Patienten mit Stadium IIA/B Hodenkrebs (Seminom).
    A.4.1Sponsor's protocol code numberSAKK01/18
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03937843
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1303-1967
    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 SponsorSwiss Group for Clinical Cancer Research (SAKK)
    B.1.3.4CountrySwitzerland
    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 supportRising Tide Foundation for Clinical Cancer Research
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportSwiss Group for Clinical Cancer Research (SAKK)
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportHedy Glor Meyer Stiftung
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportSSKK
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportRoche
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCROLLL GmbH
    B.5.2Functional name of contact pointScientific Head
    B.5.3 Address:
    B.5.3.1Street AddressWörnitzstr. 115a
    B.5.3.2Town/ cityNürnberg
    B.5.3.3Post code90449
    B.5.3.4CountryGermany
    B.5.4Telephone number004991125268846
    B.5.5Fax number004991125268840
    B.5.6E-mailtobias.leidig@crolll.de
    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 Cisplatin
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCisplatin
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCISPLATIN
    D.3.9.1CAS number 15663-27-1
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.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 Etoposide
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameEtoposide
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEtoposide
    D.3.9.1CAS number 33419-42-0
    D.3.9.4EV Substance CodeSUB07337MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.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 Carboplatin
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCarboplatin
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCARBOPLATIN
    D.3.9.1CAS number 41575-94-4
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration numberAUC7
    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
    stage IIA/B seminoma
    Seminom Stadium IIA/B
    E.1.1.1Medical condition in easily understood language
    stage IIA/B testicular cancer
    Hodenkrebs im Stadium IIA/B
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10043351
    E.1.2Term Testicular seminoma (pure) stage II
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to investigate efficacy of a stage-adapted treatment regimen in stage IIA/B seminoma.
    Die Hypothese dieser Studie ist die Untersuchung der Wirksamkeit einer stadiumadaptierten Behandlungsstrategie bei Seminompatienten im Stadium IIA/B.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Rational of the microRNAs project
    In this part of the study we aim to confirm the utility of measuring serum levels of microRNA-371a-3p for monitoring the course of the disease after completing treatment.
    To achieve that goal, serum samples are to be collected from the consenting trial patients, at baseline, after treatment and upon follow-up examinations.
    The hypothesis of this substudy is that these microRNAs are markers that could reflect disease progression in seminoma patients earlier than the traditional methods of monitoring

    Rationale of the long-term toxicity and serum platin level project:
    The substudy's objective is to confirm the utility of measuring serum levels of platin levels in patients treated with platin-based chemotherapy using the inductively coupled plasma mass spectrometry (ICP-MS) and to monitor the long-term exposure to platin which might serve as a surrogate marker for long-term adverse effects.
    Rationale des mikroRNA Projektes:
    In diesem Teil der Studie soll nachgewiesen werden, dass die Messung der Serumlevel von mikroRNA-371a-3p dazu dienen kann, den Verlauf der Erkrankung nach erfolgter Behandlung zu beobachten.
    Um dieses Ziel zu erreichen werden Serumproben der Patienten, die für den Teil der Studie eingewilligt haben, bei Baseline, nach Behandlung und während des Follow-Ups gesammelt und untersucht.
    Die Hypothese ist, dass diese mikroRNA als Marker herangezogen werden könnte, um das Fortschreiten der Krankheit bei Seminompatienten früher darzustellen, als es die Standardmethoden können.

    Rationale des Projektes zur Langzeittoxizität und zu Platinleveln im Serum
    Das Ziel dieses Subprojektes ist es Platinlevel im Serum bei Patienten, die mit einer Platin basierten Chemotherapie behandelt wurden, mittels Massenspektrometrie mit induktiv gekoppeltem Plasma nachzuweisen, um den Verlauf der Langzeitexposition von Platin zu beobachten, das möglicherweise als Surrogatmarker für späte unerwünschte Nebenwirkungen dienen kann.
    E.3Principal inclusion criteria
    - Histologically confirmed classical seminoma treated with primary inguinal orchidectomy or partial orchidectomy
    - Patients with a seminoma stage IIA or B, either newly diagnosed or recurrent after primary active surveillance, adjuvant carboplatin or radiotherapy for stage I disease
    - Stage IIA in patients with equivocal lymph node enlargement needs to be confirmed with a repeated CT/MRI scan
    - Patients with a prior malignancy treated with curative intention are eligible if all treatment was completed at least 5 years before registration and the patient has no evidence of disease at registration
    - WHO performance status 0-2
    - Adequate bone marrow and renal function
    • Histologisch bestätigtes klassisches Seminom, behandelt mit primärer inguinaler Orchiektomie oder partieller Orchiektomie
    • Patienten mit Stadium IIA oder B Seminom, entweder neu diagnostiziert oder rezidiviert nach anfänglicher aktiver Überwachung, adjuvanter Carboplatin- oder Strahlentherapie bei Stadium I Erkrankung
    •Patienten im Stadium IIA mit nicht eindeutig suspekter Lymphknotenvergrößerung muss der Befund mit wiederholtem CT/MRT Scan bestätigt werden
    • Patienten mit weiteren Tumorerkrankungen in der Vorgeschichte, die mit einer kurativen Intention behandelt wurden, sind für die Studie geeignet, solange die Behandlung mindestens fünf Jahren vor Registrierung abgeschlossen wurde, und der Patient keine Krankheitsanzeichen bei der Registrierung aufweist
    • WHO Performance Status 0-2
    • Adäquate Knochenmarks- oder Nierenfunktion
    E.4Principal exclusion criteria
    - No other histological component than seminoma
    - No elevated levels of AFP (≥ 2x ULN)
    - No involved nodes (metastatic) in previously irradiated localizations in the abdomen or pelvis
    - No anti-cancer therapy after primary tumor resection in patients presenting with primary stage IIA/B seminoma
    - No serious underlying medical condition (i.e. current renal insufficiency, severe hepatic insufficiency, severe bone marrow dysfunction, tumor bleeding, major Hearing defects) or serious co-morbidity which could impair the ability of the patient to participate in the trial (according to investigator’s judgment)
    - No concomitant drugs contraindicated for use with the trial drugs according to the approved product information or contraindicated for use with radiotherapy.
    • Keine weiteren histologischen Komponenten als das Seminom
    • Keine erhöhten AFP (≥ 2x ULN) Level
    • Keine Lymphknotenbeteiligung (Metastasen) in zuvor bestrahlten Regionen des Abdomens oder Beckens
    • Keine vorausgegangene tumorspezifische Therapie nach primärer Tumorresektion bei Patienten, die ein primäres Stadium IIA/B Seminom aufweisen
    • Keine schwerwiegenden zu Grunde liegenden Erkrankungen (z. B. gegenwärtige Niereninsuffizienz, schwerwiegende Leberinsuffizienz, schwerwiegende Knochenmarksdisfunktion, Tumorblutungen, erhebliche Hörschäden) oder schwerwiegende Begleiterkrankungen, die einen Einfluss auf die Fähigkeit zur Studienteilnahme haben könnten (nach Ermessen des Prüfarztes)
    • Keine Begleitmedikationen, die entsprechend der Fachinformation kontraindiziert gegenüber der Gabe der Studienmedikation ist bzw. gegenüber einer Strahlentherapie
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is:
    Progression free survival (PFS) 3 years after registration
    Primärer Endpunkt:
    Der primäre Endpunkt ist das progressionsfreie Überleben (PFS) 3 Jahre nach Registrierung
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 years after registration
    3 Jahre nach Registrierung
    E.5.2Secondary end point(s)
    Secondary endpoints of the trial are:
    • Response rate (RR)
    • PFS
    • Time to progression (TTP)
    • Overall survival (OS)
    • Seminoma-specific survival
    • Time to distant metastasis
    • Time to next treatment
    • Localization of progression
    • Method of detection of progression
    • Adverse events (AEs) temporarily associated with the trial treatment
    • Late AEs
    • Incidence of second tumors
    • Development of metabolic syndrome
    • Development of hypogonadism
    Sekundäre Endpunkte:
    • Ansprechrate (RR)
    • Progressionsfreies Überleben (PFS)
    • Zeit bis zur Progression (TTP)
    • Gesamtüberleben (OS)
    • Seminomspezifisches Überleben
    • Zeit bis zum Auftreten von Fernmetastasen
    • Zeit bis zur nächsten Behandlung
    • Lokalisierung der Progression
    • Nachweismethode für die Feststellung einer Progression
    • Unerwünschte Ereignisse (AEs) im zeitlichen Zusammenhang mit der Studienbehandlung
    • Späte AEs
    • Inzidenz von Sekundärtumoren
    • Entwicklung eines metabolischen Syndroms
    • Entwicklung eines Hypogonadismus
    E.5.2.1Timepoint(s) of evaluation of this end point
    at every study visit
    Bei jeder Studienvisite
    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 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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    Germany
    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
    LPLV - last patient last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years25
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years25
    E.8.9.2In all countries concerned by the trial months0
    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: 167
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    F.2 Gender
    F.2.1Female No
    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 state95
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 170
    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)
    Post-treatment examinations are in line with international guidelines
    Die Nachsorgeuntersuchungen entsprechen den üblichen Untersuchungen nach internationalen Richtlinien
    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 Decision2019-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-28
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 11:15:11 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA