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    Summary
    EudraCT Number:2004-000935-27
    Sponsor's Protocol Code Number:0468H1-313-EU
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2005-05-04
    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
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2004-000935-27
    A.3Full title of the trial
    A Randomized, Open-label, Comparative Evaluation of Conversion from Calcineurin Inhibitor Treatment to Sirolimus Treatment Versus Continued Calcineurin Inhibitor Treatment in Liver Allograft Recipients Undergoing Maintenance Therapy.
    A.4.1Sponsor's protocol code number0468H1-313-EU
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorWyeth Research Division of Wyeth Pharmaceuticals Inc.Clinical Research & Development Department
    B.1.3.4CountryUnited States
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Rapamune 1mg coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa Ltd
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 nameRapamune 1mg
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNsirolimus
    D.3.9.1CAS number 53123-88-9
    D.3.9.2Current sponsor code0468
    D.3.9.3Other descriptive nameRapamycin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeSelective immunosuppressive agent produced by conventional fermentation using Streptomyces hygroscopicus
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Rapamune 2mg coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa Ltd
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 nameRapamune 2mg
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNsirolimus
    D.3.9.1CAS number 53123-88-9
    D.3.9.2Current sponsor code0468
    D.3.9.3Other descriptive nameRapamycin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeSelective immunosuppressive agent produced by conventional fermentation using Streptomyces hygroscopicus
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Rapamune 5mg coated tablets: MA pending (positive opinion for procedure number EMEA/H/C/273/X/21 adopted on 21st oct-04)
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa Ltd
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 nameRapamune 5mg
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNsirolimus
    D.3.9.1CAS number 53123-88-9
    D.3.9.2Current sponsor code0468
    D.3.9.3Other descriptive nameRapamycin
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeSelective immunosuppressive agent produced by conventional fermentation using Streptomyces hygroscopicus
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Rapamune oral solution 1mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa Ltd
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 nameRapamune oral solution 1mg/ml
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNsirolimus
    D.3.9.1CAS number 53123-88-9
    D.3.9.2Current sponsor code0468
    D.3.9.3Other descriptive nameRapamycin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeSelective immunosuppressive agent produced by conventional fermentation using Streptomyces hygroscopicus
    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
    Liver allograft recipients under maintenance therapy
    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 demonstrate the following in stable transplant recipients:
    a) Superiority of the sirolimus (SRL) conversion regimen over the calcineurin inhibitor (CI) continuation regimen with regard to the change from baseline in calculated glomerular filtration rate (GFR, Cockcroft-Gault method) at 12 months. The comparison will be performed on an intent-to-treat (ITT) basis (incorporating calculated GFRs for all subjects for whom a 12-month creatinine value is available).
    b) Non-inferiority of the SRL conversion regimen with regard to the rate of the first occurence of graft loss or death at 12 months in the ITT population.
    E.2.2Secondary objectives of the trial
    To compare the following between the 2 treatment groups:
    a) incidence of biopsy-confirmed acute rejection
    b) subject and graft survival
    c) change in creatinine values in the ITT and on-therapy populations
    d) GFR values calculated by the methods of Cockcroft-Gault and Levey and measured GFR values for the ITT and on-therapy population
    e) slope of the regression line for a plot of 1/creatinine and GFR values versus time
    f) incidence of treatment failure (defined as the first occurence of acute rejection or premature discontinuation from treatment for any reason)
    g) mean systolic and diastolic blood pressures and mean arterial pressure
    h) percentage of subjects requiring treatment for hypertension and number of antihypertensive agents used
    i) quality of life outcomes
    j) change in the hepatic fibrosis score over time
    k) incidence of malignancy and infection
    l) long term safety for up to 6 years
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Age >=13 years (>=18 years in Austria, Czech Republic, Denmark, Finland, France, Germany, Norway, Poland, Sweden, Switzerland, United Kingdom and as required by local regulation or ethical committees) and weight >=40 kg.
    2. Women of childbearing potential must have a negative serum pregnancy test result before random assignment and must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of randomly assigned treatment. Any woman becoming pregnant during the treatment period must withdraw from the study.
    3. Subjects receiving immunosuppressive therapy with a stable regimen of CI or a combination of CI with CS and/or antimetabolite therapy for a minimum of 4 weeks prior to randomization.
    4. Treatment with the same CI for at least 4 weeks before random assignment.
    5. Six (6) to 144 months after orthotopic liver transplantation.
    6. Cockcroft-Gault GFR values >=40 mL/min and <=90 mL/min at screening.
    7. Doppler ultrasound performed within 4 weeks before random assignment showing no evidence of thrombosis or of clinically significant stenosis of hepatic artery, hepatic vein, or portal vein.
    8. Total white blood cell count >3.0 x 10 9/L (>3,000/mm3), platelet count >75 x 10 9/L (>75,000/mm3 ), fasting triglycerides <3.95 mmol/L (<350 mg/dL), fasting cholesterol <7.8 mmol/L (<300 mg/dL). If subjects are currently untreated for elevated cholesterol and/or triglycerides and are excluded from the study based on the above criteria, subjects may be initiated on antihyperlipidemic therapy and re-screened.
    9. Liver function test (LFT) results (ie, aspartate aminotransferase [AST], alanine aminotransferase [ALT], total bilirubin, and alkaline phosphatase) <3 times the upper limit of normal on 2 consecutive determinations within 3 months before random assignment. For subjects who are Hepatitis C positive (determined by PCR), AST and ALT values must be < 5 times the upper limit of normal on 2 consecutive determinations within 3 months before random assignment.
    10. Subjects with any LFT (AST, ALT, total bilirubin, or alkaline phosphatase) >2 times the upper limit of normal (on 2 consecutive determinations within 3 months before random assignment) must have a liver biopsy performed within 3 months before random assignment showing no evidence of acute rejection unless a clear alternative etiology is apparent for elevated LFTs.
    Subjects who are Hepatitis C positive (determined by PCR) with total bilirubin or alkaline phosphatase values > 2 times the upper limit of normal on 2 consecutive determinations less than 3 months before random assignment, must have a liver biopsy performed less than 3 months before random assignment to exclude rejection unless a clear alternative etiology for elevated LFT(s) is apparent. Prior discussion with the medical monitor about the alternative etiology is required before randomizing any patient who meets this criteria.
    11. All Hepatitis C positive subjects (as determined by PCR) must have a liver biopsy performed within 6 months before random assignment showing no evidence of acute rejection or Liver Fibrosis score 4, 5 or 6 (Banff 1997) or correlating Metavir score of F3 or F4 (See Attachment 10).
    12. Subjects undergoing therapy for Hepatitis C infection who completed a full course of therapy must be at least 6 months post therapy. Subjects who were non-responders or who failed HCV therapy, must be at least 4 weeks post discontinuation of therapy (See Screening and Evaluating for Hepatitis C Virus Status in section 11 of the synopsis and Study Flowchart 6).
    13. Subjects who had malignant liver tumors (primary hepatocellular carcinoma) discovered incidentally at the time of transplantation or coincidentally before transplantation may be enrolled if they had 1) a primary solitary liver tumor of less than 5 cm or 2) 3 or fewer lesions with none exceeding 3 cm in diameter, without extrahepatic metastases.
    14. Subjects with malignant liver tumors (primary hepatocellular carcinoma) that were treated with chemoembolization or radiofrequency ablation before transplantation and who meet the above criteria may be enrolled unless systemic chemotherapy was/is being administered. However, patients may be enrolled if post-transplant prophylactic chemotherapy was discontinued > 6 months before random assignment.
    15. Written, signed, and dated IRB- or IEC-approved informed consent (subjects younger than the legal age of consent will sign an assent form, but a parent or legal guardian must provide written permission).
    E.4Principal exclusion criteria
    1. History of nonhepatic transplantation.
    2. Serum creatinine at the time of screening that has increased > 30% above the last value obtained at least 8 weeks prior to screening. Subjects with values that deviate from this exclusion criterion may be enrolled only with the approval of the Wyeth Research (WR) global medical monitor.
    3. Concomitant therapy with an immunosuppressive agent other than CI, CS, or antimetabolite therapy (MMF or AZA) within 4 weeks before random assignment.
    4. Evidence of systemic infection (ie, sepsis, bacteremia, pneumonia, etc.) at time of random assignment.
    5. Biopsy performed within 3 months before random assignment showing Banff 1997 grade I or II acute rejection or biopsy performed within 12 months before random assignment showing grade III rejection.
    6. Any treatment for suspected or biopsy-confirmed acute rejection within 3 months before random assignment or treatment with anti-lymphocyte antibody for suspected or biopsy-confirmed acute rejection within 12 months before random assignment.
    7. Stage 4, 5 or 6 hepatic fibrosis score using Banff 1997 scoring criteria or correlating Metavir fibrosis grade F3 or F4 on any posttransplant biopsy and/or in the opinion of the investigators, signs of decompensated liver disease of the current liver allograft.
    8. Therapy for recurrent Hepatitis B infection received within 4 weeks before random assignment (excluding approved prophylaxis).
    9. Known or suspected malignancy <= 5 years before random assignment (with the exception of adequately treated basal cell or squamous cell carcinomas of the skin or malignant liver tumors [primary hepatocellular carcinoma] as specified in inclusion criteria 13 and 14).
    10. History of posttransplant lymphoproliferative disease.
    11. Use of any investigational drugs within 4 weeks before random assignment.
    12. Prior or current use of SRL or any of its derivatives (unless prior approval from WR medical monitor).
    13. Treatment with any renal replacement therapy within 2 weeks before random assignment.
    14. Presence of unstable angina or use of ongoing maintenance therapy for a life-threatening arrhythmia.
    15. History of documented human immunodeficiency virus infection.
    16. Hypercoagulable states or any history of deep vein thrombosis, HAT, or portal vein thrombosis . (Exception: incidental vascular thrombosis at time of liver explant which, in the opinion of the investigator, does not place the subject at increased risk of thrombotic event).
    17. Requirement for the administration of terfenadine, cisapride, pimozide, astemizole, (oral) ketoconazole, voriconazole or cimetidine after random assignment.
    E.5 End points
    E.5.1Primary end point(s)
    1. The change from baseline in calculated GFR (Cockcroft-Gault method) at 12 months in the ITT population (incorporating calculated GFRs for all subjects for whom a month 12 creatinine value is available).
    2. The rate of the first occurrence of graft loss or death at 12 months in the ITT population.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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.8.3 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    The study is expected to be completed with the last visit of the last subject. However Wyeth Research may terminate the study at any time for any of the following reasons:
    1. Failure to enroll subjects.
    2. Protocol violations.
    3. Inaccurate or incomplete data.
    4. Unsafe or unthetical practices.
    5. Questionable safety of the test article.
    6. Suspected lack of efficacy of the test article.
    7. Marketing authorization in the respective region or country.
    8. Administrative decision.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months85
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months85
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    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 2005-05-04. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 600
    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 Decision2005-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-05-18
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
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