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    Summary
    EudraCT Number:2009-015953-18
    Sponsor's Protocol Code Number:DORIPED3002
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2011-09-14
    Trial results View 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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2009-015953-18
    A.3Full title of the trial
    A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Cefepime in Hospitalized Children With Complicated Urinary Tract Infections
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Safety and Tolerability Study of Doripenem Compared with Cefepime in Children Hospitalized with Complicated Urinary Tract Infections
    A.4.1Sponsor's protocol code numberDORIPED3002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01110408
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/192/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
    B.1.3.4CountryBelgium
    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 supportJohnson & Johnson Pharmaceutical Research & Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen- Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressJanssen Biologics BV - Clinical Registry Group
    B.5.3.2Town/ cityArchimedesweg 29
    B.5.3.3Post code2333CM Leiden
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715242166
    B.5.5Fax number+31715242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.com
    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 DORIBAX
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Powder for 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 INNDORIPENEM MONOHYDRATE
    D.3.9.1CAS number 364622-82-2
    D.3.9.2Current sponsor codeJNJ-38174942
    D.3.9.3Other descriptive nameDORIPENEM
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 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 MAXIPIME
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb S.p.A
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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.3.4Pharmaceutical form Powder for 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.3.9.3Other descriptive nameCEFEPIME DIHYDROCHLORIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB26333
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 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.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Powder for 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.3.9.3Other descriptive nameCEFEPIME DIHYDROCHLORIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB26333
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Complicated Urinary Tract Infections
    E.1.1.1Medical condition in easily understood language
    Complicated Urinary Tract Infections or pyelonephritis
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10046571
    E.1.2Term Urinary tract infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to establish the safety and tolerability profile of doripenem compared with that of cefepime in hospitalized children 3 months to <18 years of age with cUTI (complicated Urinary Tract Infection).
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    •To determine the clinical cure rate of doripenem compared with that of cefepime at the TOC (Test Of Cure) visit
    •To determine the favorable microbiological response rate of doripenem compared with that of cefepime at the TOC visit
    •To determine the clinical improvement rate of doripenem compared with that of cefepime at the end of treatment with IV study drug therapy (EIV) visit
    •To determine the favorable microbiological response rate of doripenem compared with that of cefepime at the EIV visit
    •To determine the sustained clinical cure rate of doripenem compared with that of cefepime at the late follow-up (LFU) visit
    •To determine the favorable microbiological response rate of doripenem compared with that of cefepime at the LFU visit
    •To characterize the pharmacokinetics of doripenem in hospitalized children with cUTI based on a sparse pharmacokinetic sampling scheme
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1- Have evidence of pyuria as demonstrated by either of the following:
    o A urine specimen that is positive for leukocyte esterase via urine dipstick or urinalysis
    o A urine specimen with ≥10 WBCs per microliter from an unspun sample or ≥5 WBCs per high power field from a centrifuged specimen.
    2- Have a current documented or suspected cUTI or pyelonephritis as indicated by the following clinical signs or symptoms:
    COMPLICATED URINARY TRACT INFECTION
    o Symptomatic cUTI
    Children 3 months to <2 years of age
    Must have at least ONE of the following signs or symptoms:
    – Vomiting
    – Recent weight loss or failure to thrive
    – Abdominal pain
    – Irritability
    – Poor feeding
    – Decrease in normal level of activity
    AND
    – have at least ONE complicating factor (see below)
    Children 2 to <18 years of age
    Must have at least ONE of the following signs or symptoms:
    – Dysuria
    – Increased urinary frequency
    – Urgency
    – Suprapubic or abdominal pain
    – Secondary urinary incontinence
    AND
    – have at least ONE complicating factor (see below)
    o Asymptomatic cUTI
    Children 3 months to <18 years of age
    Must be unable to perceive symptoms of UTI due to congenital or acquired spinal cord injury or abnormality
    AND
    have at least ONE complicating factor (see below)
    Complicating Factors for All Age Categories (3 months to <18 years of age): All subjects enrolled with a diagnosis of complicated UTI must have at least ONE of the following complicating factors:
    - Indwelling urinary catheter or other indwelling urinary tract instrumentation that is anticipated to be removed during the course of IV study drug therapy
    - Use of intermittent urinary catheterization
    - Urogenital surgery within the 7 days before administration of the first dose of IV study drug
    - Known functional or anatomic abnormality of the urogenital tract
    - Obstructive uropathy where the obstruction is likely to resolve or be relieved during the course of IV study drug therapy administration
    - Previously documented vesicoureteral reflux
    - Neurogenic disturbances of micturition with significant impact on bladder emptying with bladder residual volume ≥50 mL for children weighing <40 kg and ≥100 mL for children weighing ≥40 kg as previously determined by voiding cystourethrogram (VCUG) or ultrasound or urinary catheterization immediately post void. (Chang 2009)
    - Recurrent UTI (defined as 2 or more previous UTIs within a 12-month period)
    - Evidence that the current UTI may be caused by a resistant uropathogen including a suspected breakthrough infection in a child receiving chronic antimicrobial prophylaxis for the prevention of UTI
    - Prior documentation of congenital structural or functional urologic
    abnormality including but not limited to findings from prenatal or postnatal ultrasound or postnatal VCUG
    PYELONEPHRITIS
    Subjects in all age categories (3 months to <18 years of age) enrolled with a diagnosis of pyelonephritis must have both:
    Evidence of systemic inflammatory response as demonstrated by at least ONE of the following:
    o Fever (oral temperature >38.0C, tympanic temperature >38.3C, or rectal or core temperature >38.8C) or hypothermia (rectal or core temperature <35.0C)
    o Have leukocytosis defined as WBC >or=15,000 cells/microL OR >or=15% immature neutrophils, regardless of the total peripheral white cell count
    AND
    Have at least ONE of the following signs or symptoms:
    Children 3 months to <2 years of age
    – Vomiting
    – Recent weight loss or failure to thrive
    – Abdominal pain
    – Irritability
    – Poor feeding
    – Decrease in normal level of activity
    Children 2 to <18 years of age
    – Nausea
    – Vomiting
    – Chills
    – Dysuria
    – Increased urinary frequency
    – Urgency
    – Lower back or flank pain or costovertebral angle tenderness
    3- Must, based on the judgment of the investigator, require hospitalization initially and 10 to 14 days of antibacterial therapy for the treatment of the presumed cUTI. (Note that the subject must require at least 3 days of IV antibiotic therapy initially).
    E.4Principal exclusion criteria
    1 - Have a history of hypersensitivity reactions to carbapenems, cephalosporins, penicillins, or other beta-lactam antibiotics. Note: Subjects with a history of mild non-urticarial skin rash temporally related to but considered not associated with the previous use of beta-lactam antibiotics are permitted to enroll in the study. For such subjects, there must be a description of the rash and documentation by the investigator that upon review of the history it is his/her opinion that the rash was unlikely due to any of the above-mentioned classes of drugs for the subject to qualify for inclusion in the study.
    2 - Concomitant infection including but not limited to suspected or confirmed meningitis or other central nervous system infection requiring systemic antibiotic or antifungal therapy at the time of randomization. (Clarification: possible bacteremia with the presumed same urinary pathogen is acceptable).
    3 - Received any amount systemic antibiotic therapy within 96 hours (4 days) before obtaining the pretreatment baseline urine culture specimen. (Exception: Subjects receiving oral antibiotics for UTI prophylaxis and are suspected to have a breakthrough UTI are eligible to enroll if all other eligibility criteria are met including obtaining a baseline urine culture specimen).
    4 - Have received more than 24 hours of systemic antibiotic therapy after obtaining the pretreatment baseline urine culture specimen
    5 - Girls who are pregnant or are nursing a child or are menarchal, and, if sexually active, are not practicing a highly effective method of birth control (eg, prescription hormonal contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method, eg, condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel, male partner sterilization) as local regulations permit, before screening and do not agree to continue using a highly effective method of birth control (as previously described) for 30 days after administration of the last dose of study drug therapy. Note: for all menarchal girls, confirm a negative urine or serum pregnancy test (beta-human chorionic gonadotropin [beta-hCG]) at screening, before enrolling the subject into the study.
    6 - Have a history of uncontrolled epilepsy defined as at least 1 seizure within the 6 months before randomization
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events, Clinical laboratory tests and Vital signs measurements
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline up to 42 days after the last dose of study drug
    E.5.2Secondary end point(s)
    1 - To determine the clinical cure rate and favorable microbiological response rate of doripenem compared with that of cefepime at
    the test of cure (TOC) visit
    2 - To determine the clinical improvement rate and favorable microbiological response rate of doripenem compared with that of
    cefepime at the end of treatment with iv study drug therapy (EIV) visit
    3 - To determine the sustained clinical cure rate and favorable microbiological response rate of doripenem compared with that of cefepime at the late follow-up (LFU) visit
    4 - To characterize the pharmacokinetics of doripenem in hospitalized children with cUTI on the basis of a sparse pharmacokinetic sampling scheme
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 - 7 to 14 days after the last dose of iv study drug including oral antibiotic therapy
    2 - Within 24 hours after completion of the last dose of iv study drug
    3 - 28 to 42 days after the last dose of iv study drug including oral antibiotic therapy
    4 - 1, 2, 4 and 6 hours after the 4th, 5th, 6th, or 7th dose administrations of doripenem/doripenem placebo
    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 No
    E.6.6Pharmacokinetic Yes
    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
    tolerability
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Argentina
    Brazil
    Colombia
    Czech Republic
    Germany
    India
    Latvia
    Lithuania
    Mexico
    Panama
    Poland
    Uganda
    Ukraine
    United States
    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
    End of trial is last visit of the last subject (Late Follow Up visit)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days17
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 140
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 26
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 54
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric population: subjects from 3 months to <18 year of age.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 140
    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)
    After the study is over, the sponsor will not continue to provide the subject with the study medication. The subjects will be followed by the study doctor according to the local standard of care.
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: United States
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