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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
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    The EU Clinical Trials Register currently displays   43843   clinical trials with a EudraCT protocol, of which   7282   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).

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    Summary
    EudraCT Number:2012-000447-27
    Sponsor's Protocol Code Number:USKH_VL1
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2012-04-23
    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 number2012-000447-27
    A.3Full title of the trial
    Open Label Study for the Functional Characterization of Drug Metabolism and Transport in patients before routine visceral surgery
    Offene Studie zur funktionellen Charakterisierung von Arzneimittelmetabolismus und –transport in Patienten vor abdominellen Routineeingriffen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open Label Study for the Functional Characterization of Drug Metabolism and Transport in patients before routine visceral surgery
    A.4.1Sponsor's protocol code numberUSKH_VL1
    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 SponsorUniversitätsklinikum Schleswig-Holstein, Campus Kiel
    B.1.3.4CountryGermany
    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 supportBmBf
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Schleswig-Holstein, Campus Kiel
    B.5.2Functional name of contact pointKlinik für Allgemeine Chirurgie
    B.5.3 Address:
    B.5.3.1Street AddressArnold-Heller-Str. 3, Haus 18
    B.5.3.2Town/ cityKiel
    B.5.3.3Post code24105
    B.5.3.4CountryGermany
    B.5.4Telephone number+4943150020401
    B.5.5Fax number-4943150020404
    B.5.6E-mailwitigo.vonschoenfels@uksh.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 Codeintropfen-CT
    D.2.1.1.2Name of the Marketing Authorisation holderCT Arzneimittel
    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 nameCodeinphosphat-Hemihydrat
    D.3.4Pharmaceutical form Oral drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCODEINE PHOSPHATE HEMIHYDRATED
    D.3.9.4EV Substance CodeSUB30038
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number21,72
    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 Midazolam-ratiopharm
    D.2.1.1.2Name of the Marketing Authorisation holderratiopharm
    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 nameMidazolam
    D.3.4Pharmaceutical form Oral drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMIDAZOLAM
    D.3.9.1CAS number 59467-70-8
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB08950MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 Pravastatin
    D.2.1.1.2Name of the Marketing Authorisation holderHEXAL
    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 namePravastatin-Natrium
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 81131-70-6
    D.3.9.3Other descriptive namePRAVASTATIN SODIUM
    D.3.9.4EV Substance CodeSUB04011MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 4
    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 No
    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 nameTorasemid
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTORASEMIDE
    D.3.9.1CAS number 56211-40-6
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB11195MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,25
    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
    Pharmacokinetic trial in patients, with a good general condition before standard abdominal surgery
    E.1.1.1Medical condition in easily understood language
    good general condition, absence of any decompensated condition. Inclusion of patients with compensated impaired liver or renal function
    E.1.1.2Therapeutic area Not possible to specify
    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
    To establish a cohort of patients before routine visceral surgery. This cohort should serve as a patient cohort for the related healthy volunteer study in Tübingen, Germany (IKP243; EudraCT: 2011-002291-16).
    Functional pharmacokinetic phenotyping of major drug metabolism pathways (cytochrome P450 1A2, 2C9, 2D6, 3A4/5, and uridine glucuronosyl transferase 2B4/7) and drug transporter (OATP1B1) pathways.
    Functional measurement of liver metabolic function
    E.2.2Secondary objectives of the trial
    Noninvasive functional characterization of liver, heart, and kidneys using MRI
    Detailed multi-scale modeling of individuals and personalized prediction of liver detoxification capacity based on biomarkers
    Sampling of biological material (serum, plasma, peripheral blood cells)
    Generation of hypotheses and identification and evaluation of (epi)genetic, genomic, transcriptomic, proteomic and metabolic biomarkers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients before elective visceral surgery including patient with Child A/B liver cirrhosis and/or compensated renal impairment (grade 1-2) without severe edema, ascites etc..
    2. Written informed consent obtained prior to study entry including informed consent for genetic research
    3. Both genders (male and female)
    4. Adults aged ≥18 to <85 years
    5. BMI of subjects of both genders not less than 18 kg/m² and/or not greater than 75 kg/m².
    6. Smokers and nonsmokers.
    7. Willingness to meet the study instructions and to co-operate with the study personal
    8. Female subjects will only be included if they have negative pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception as specified in the respective protocol section.
    E.4Principal exclusion criteria
    1. Participation in a clinical trial involving the administration of medicines during the last 30 days or use of any other investigational or non-registered drug or vaccine during the study period or within 30 days preceding the first dose of study drugs
    2. Blood, plasma or thrombocyte donation during the last 30 days prior to application of the test drugs.
    3. Pregnancy or lactation period
    4. Bradycardia, prolonged PQ-time, AV-block.
    5. Raynaud’s syndrome
    6. Short bowel syndrome, previous bariatric surgery, chronic inflammatory bowel disease (Crohn disease, ulcerative colitis), malabsorption, celiac disease, previous operative intestinal anastomoses such as Y-Roux as they may interfere with the PK of the study drug
    7. Patients with any decompensated medical condition, cardiac failure, edema, active infection, sepsis, open wounds, necrosis, uncontrolled psychiatric disorder or psychosis.
    8. Inability to walk, dementia, parenteral nutrition or nutrition over enteral feeding tube.
    9. Change of the concomitant standard medication of the patients within the last two weeks unless allowed for the specific drug as detailed in the “Concominant Medication” section 3.4.2.
    10. Active alcohol and/or drug addiction and/or active abusive use of medicaments.
    11. Transplanted patients.
    12. History of severe hypersensitivity reactions and anaphylaxis.
    13. History of intolerance or allergic reactions to or contraindication for any of the IMPs. If intolerance, allergic reactions to or contraindication against one of the IMPs is known, enrolment is possible but application of the concerned substance must not be allowed in the affected individual and all siblings (e.g. allergy to sulphonamide prohibits specifically the application of torasemide)
    14. Contraindication against MRI, e.g. pacemakers, cochlea implants, aneurysm clips, claustrophobia, allergy against gadolinum-containing contrast agents. If allergic reactions against gadolinum-containing contrast agents is known, enrolment is possible but the affected patient is excluded from MRI.
    15. Inability or unwillingness to provide informed consent and to abide by the requirements of the study

    E.5 End points
    E.5.1Primary end point(s)
    Blood levels and clearance (dose/AUC) of midazolam, torasemide, codeine, pravastatin
    Endogenous CYP3A markers (urinary 6betaOH cortisol/cortisol ratio or plasma 4-OH cholesterol (CYP3A4/5))
    Blood levels and clearance (dose/AUC) of caffeine, paraxanthine, 5-acetylamino-6-formylamino-3-methyluracil (AFMU), 5-acetylamino-6-amino-3-methyluracil (AAMU)
    PK variables are:
    Area under plasma concentration versus time curve (AUC), oral clearance (CL/F), maximum plasma drug concentration (Cmax), terminal half-life (t½), time to reach Cmax (tmax) and oral volume of distribution (V/F)
    E.5.1.1Timepoint(s) of evaluation of this end point
    While visit 2
    E.5.2Secondary end point(s)
    Plasma metabolite profiles and PK parameters (1-OH-midazolam, OH-torasemide (M1), carboxy-torasemide (M5), morphine, codeine-6-glucuronide, morphine-6-glucuronide, morphine-3-glucuronide, norcodeine, normorphine)
    Urinary levels of 1-OH-midazolam, codeine-3-glucuronide, codeine-6-glucuronide, morphine-6-glucuronide, morphine-3-glucuronide, norcodeine, normorphine, pravastatin, AFMU, AAMU
    Plasma and/or urinary metabolic ratios of parent compound versus the metabolites generated by the enzymes of interest (Table 5).
    Following selected secondary endpoints will be calculated per phenotyping probe:
    Pravastatin
    -Elimination rate constant of pravastatin as an indicator of hepatic OATP1B1 activity
    Codeine:
    -Renal excretion (Ae) of morphine as an indicator of CYP2D6 activity
    -Renal excretion (Ae) of codeine-glucuronides and morphine-glucuronides as indicators of UGT2B4 and -2B7 activity
    -Renal excretion (Ae) of norcodeine and normorphine as indicators of CYP2C8 and CYP3A4 activities
    Torasemide:
    -Metabolite formation clearances for torasemide as indicators of hepatic CYP2C9 activity
    13C-caffeine test:
    -Urinary metabolite ratio of caffeine metabolites AAMU and AFMU as indicators of hepatic NAT2 activity
    -1,7-Dimethylxanthine (paraxanthine) over caffeine plasma metabolic ratios at 2 hours as an indicator of hepatic CYP1A2 activity
    Laborchemical parameters for liver and renal function
    Liver MRI (facultative): Cross-sectional area (S), maximum velocity (Vmax), Mean velocity (Vmean), and flow rate (Q) of portal and proper hepatic artery; liver volume (LV)
    Cardiac MRI (facultative): left / right ventricular end-diastolic volume (LVEDV, RVEDV), left / right ventricular end-systolic volume (LVESV, RVESV), left / right ventricular ejection fraction (LVEF, RVEF), left / right ventricular stroke volume (LVSV / RVSV)
    Body composition MRI (facultative): visceral adipose tissue, subcutaneous adipose tissue, sagittal and transverse abdominal diameters
    Spirometry (facultative): minute ventilation (VE), oxygen consumption (VO2), carbon dioxide production (VCO2), heart rate (HR), blood pressure (RR) and respiratory frequency (RF).
    E.5.2.1Timepoint(s) of evaluation of this end point
    while visit 2
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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.8.5The 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
    closure of clinical trial data base
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 200
    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 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    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)
    standart treatment according to the surgery
    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 Decision2012-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-09
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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